Psycho-Babble Medication Thread 55118

Shown: posts 1 to 12 of 12. This is the beginning of the thread.

 

Media Qs about Wellburin aka Zyban, CamW?? and...

Posted by dj on February 28, 2001, at 12:42:18

The following article is from a Montreal newspaper and the info. after that is from the link cited at the end of the article.

I took Wellbutrin for four months or so 1.5 years ago and don't recall any flagrant reactions and am considering taking it again. However I am curious what CamW. or Sunnely or informed others might have to say about the following published info. which raises questions but no clear answers, in the highlighted case at least.

I'm wondering if the general reactions cited in Health Canada's "Canadian Adverse Drug Reaction Newsletter" are extraordinary for an AD or any medication for that matter?. There are no other ADs cited there, in the DRUGS OF CURRENT INTEREST section, that I recognize.

dj


From: http://www.montrealgazette.com/

Monday 26 February 2001

Kicking the habit: Can anti-smoking pill kill?

JEFF HEINRICH
The Gazette

MARCOS TOWNSEND, GAZETTE / David Landry, found dead on the kitchen floor of his Plateau Mont Royal apartment, had been taking Wellbutrin after quitting smoking. Friends said the pills made his heart race.

His name was David Landry, he was 26, and he was trying to quit smoking. But in the end it was his life, not just his habit, that got snuffed out.

Did his anti-smoking medication kill him?

His friends in Montreal and his family back home in Moncton, N.B., believe so, and a Quebec coroner is investigating the suspected link, adding to a long list of similar cases being probed worldwide.

Landry was found dead on the kitchen floor of his Plateau Mont Royal apartment two weeks ago, a sponge by his side and a bottle of little purple pills in the adjacent bathroom.

The pills were bupropion hydrochloride. Taken by more than one million Canadians and subsidized in Quebec under the province's drug-insurance plan, it's a stimulant used to treat depression or to help people stop smoking.

It's sold under a couple of names: Wellbutrin and Zyban.

Smokers pop two pills a day for three months, hoping they'll be one of the lucky one in three for whom the drug cuts the body's craving for nicotine, breaking the habit.

Landry, a tattooed astrology buff and painter who ate vegetarian and made his living in telemarketing, had been on the medication for 10 days, and had doubled the dosage as prescribed after the first week.

According to friends, the pills had made his heart race and his mood slightly euphoric. But figuring those were just normal side-effects of the drug, and adamant that he would quit smoking, he kept taking it.

"There was nothing that really triggered any alarm in him or in us, his friends," said hairdresser Jenn Griffin, 24, whose family doctor prescribed Landry his Wellbutrin.

"It was just the usual side-effects."

Griffin found Landry's body in his Gilford St. flat the night of Feb. 11. Stunned, searching for an explanation, she leaped to the conclusion that the pills in the bathroom cupboard had been her friend's downfall.

"There was no other explanation. He was healthy, he had no history of heart problems, just a bit of depression in his family. From the moment I found him, I knew it was the (Wellbutrin) that killed him."

But the coroner won't yet go that far.

"It's surprising when a young man of 26 dies suddenly and non-violently," said Francois Houle, of the coroner's office.

"But until the police and coroner's investigations are complete, it's too early to say" whether the pills were the cause, he added.

The drug's manufacturer, the pharmaceutical giant GlaxoSmithKline, denies any suggestion its product can cause death.

"There has not been a direct link between Zyban and fatalities - it's unproven," said Carlo Mastrangelo, spokesman at Glaxo's Canadian headquarters in Mississauga, Ont.

But there is no denying the controversy.

In the three years since it started being marketed internationally as an aid to stop smoking, bupropion has been suspected as the cause of hundreds of cases of unwanted side-effects and even death.

In several Western countries, including Canada, health authorities are monitoring so-called "adverse events" associated with the drug.

Among the more severe side-effects reported have been seizures, strokes, heart attacks, psychotic episodes and depression. In Britain, Australia and Canada, Zyban has been suspected in at least 22 deaths.

"There's a kind of panic right now about Zyban," said Marcel Boulanger, a retired anesthetist who runs the Montreal Heart Institute's smoking-cessation program.

"It's true the drug has a number of undesirable effects; it's not a harmless drug," said Boulanger, an occasional paid consultant to Glaxo who has taught medical students how to prescribe it.

But put in perspective, he added, the risk is very low. More than one million Canadians have taken the drug since it came on the market in mid-1998, but at last count only 407 Zyban users and 67 Wellbutrin users have had any adverse reaction.

Health Canada statistics compiled in January 2000 show that 256 of those Zyban reactions were serious. They included three people who died of heart attacks; two had a history of heart disease.

Because smokers are at risk of a lot of deadly and debilitating things anyway, and because quitting smoking itself can be stressful, it's hard to pinpoint Zyban as aggravating their condition - least of all causing death.

Landry was a case in point.

Like many in his circle in the bohemian Plateau, he liked to go to bars, drink, smoke a bit of pot, his friends say. And before he tried to quit, he was a half-a-pack-a-day cigarette smoker.

While on his medication, however, he cleaned up his act. A few days before he died, for example, he declined an invitation from friends to go out drinking. He knew alcohol and bupropion don't mix.

The drug's labeling carries other warnings: it can cause seizures in one patient per 1,000 and has milder side-effects, like insomnia, dry mouth and skin rashes. Those are the ones Glaxo emphasizes on its packaging.

But now concerns over a link to fatal heart attacks and mental problems have put the company on the defensive, as it fends off a backlash by doctors and anti-smoking advocates who once hailed the drug.

In Australia, where the drug went on sale last November, the Melbourne newspaper the Age said last week there have been 68 official reports of suspected adverse events, including 24 reports of psychological disturbances and one death - a patient who suffered a massive lung clot about three days after stopping Zyban.

Psychiatrists and family doctors warned last Monday that the drug could trigger a psychotic episode in schizophrenics and should be used with caution. In England, the national Department of Health is also monitoring Zyban after receiving notification of 18 deaths possibly associated with the drug.

Zyban has been approved for smoking-cessation in Canada, the United States, Australia, New Zealand and most European countries. Glaxo estimates that more than 15 million people worldwide have taken Zyban since it was first marketed in 1997. Last year in Canada, pharmacists filled out 1.2 million prescriptions for Zyban and Wellbutrin, totaling $70 million in retail sales, the drug statistics firm IMS Health Canada estimates.

Landry was one of those who tried it. His bottle of Wellbutrin cost him $60. Until the coroner's report, it will be unclear whether he ultimately paid a much higher price: his life.

"The take-home message for people thinking of taking a new medication is to always be on guard," said Mark Palayew, a respirologist at Jewish General Hospital. "Always beware and make sure you don't fit the profile of someone who shouldn't be taking that drug."

- GlaxoSmithKline's corporate Web site for Zyban is www.zyban.com/

- For details of problems with Zyban reported in Canada, consult Health Canada's Adverse Drug Reaction Newsletter of January 2000. It's on the Web at www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/publicat/adrv10n1_e.html

Bupropion (Zyban«, sustained-release tablets): update

Adverse drug reactions (ADRs) to Zyban« (marketed in Canada since August 1998) were previously reported in the April 1999 issue of this newsletter.1 The CADRMP continues to receive spontaneous ADR reports for Zyban« sustained-release tablets, and as of Sept. 16, 1999, received 407 reports (Table 1), of which 256 were serious. Also received were 67 reports for Wellbutrin SR«, another brand of sustained-release bupropion, which is indicated for the relief of symptoms of depression. These 2 drugs contain the same active ingredient, but because of their use in different patient populations this article will focus on Zyban« as indicated for smoking cessation. Although not all of the ADRs in Table 1 are currently listed in the product monograph, it is important to read the product monograph carefully to minimize the risk of ADRs.

Among the cases reporting cardiovascular reactions were 3 deaths, including 2 from myocardial infarction (in a 52-year-old man1 and a woman in her 60s with a history of coronary artery disease) and 1 from cardiac arrest (in a 53-year-old man with a pulmonary embolism). In addition to the 2 cases of fatal myocardial infarction, there were 7 nonfatal cases of myocardial infarction (2 women, 5 men; age range 44-69 years). Three of these 7 patients had prior cardiovascular disease; another had unspecified risk factors.

The CADRMP received 64 reports of convulsions or grand mal convulsions. Two of the grand mal convulsions were reported as status epilepticus. In one case, a 49-year-old woman had had a single seizure 25 years earlier, and in the other a woman of unknown age had had a single seizure 20 years before this event. Neither reported the use of concomitant medications. The events were reported to have resolved without sequelae in both instances. Among the 64 reports, 29 included the following risk factors for seizure: history of head injury (1); alcohol use (5); diabetes mellitus (4); history of seizure (7); and use of concomitant medications that may lower seizure threshold: antidepressants (4), mefloquine (1) and antipsychotics (1). There were 6 reports of patients who took Zyban« in other than the recommended dose. The risk of seizures with the use of bupropion is associated with a dose-dependent effect.2 Bupropion should be administered with extreme caution in patients at risk of seizures because of clinical conditions or concurrent medications.2

Seven cases of hypoglycemia were reported. In 5 cases the patients were taking insulin concomitantly. Another case involved a Zyban« overdose. Three of the 7 patients also suffered convulsions; 2 of them were taking insulin. The current product monograph indicates that the use of buproprion in diabetic patients treated with oral hypoglycemic agents or insulin is associated with an increased risk of seizure.2

There were 128 cases reporting predominantly allergic reactions. In an additional 35 cases allergic reactions were reported in combination with musculoskeletal disorders, including 14 cases of serum sickness (8 women and 6 men; age range 21-46, age unknown in 1 case). Four of the patients with serum sickness were admitted to hospital, and for 2 others the event was considered disabling. Four of the 14 cases of serum sickness were reported as serum-sickness-like syndrome.

There were 52 cases in which psychiatric reactions were reported predominantly. Among these were 7 cases of suicidal ideation (Table 1) in which 2 of the patients had a history of depression. One case of suicide attempt was also reported.

Sixteen reports of visual disturbances were received (8 women, 7 men, 1 sex unknown; age range 21-62 years). The following symptoms occurred: blurred vision, photosensitivity, dilated pupils, decreased vision, retinal vein occlusion, amblyopia, diplopia, difficulty reading, watery eyes, glaucoma, spots, conjunctivitis and myopia.

Spontaneous postmarketing ADR reports constitute one of the key elements used by the TPP to detect new signals and update the product monograph and labelling information. The TPP continues to work with the manufacturer to re-evaluate and update the safety profile of Zyban«.

Written by: Heather Dunlop, BNSc, MLIS, Bureau of Drug Surveillance.

References

HÚbert S. Bupropion (Zyban«, sustained-release tablets): reported adverse reactions. Can Adverse Drug Reaction Newsl 1999;9(2):1-2. [Also in CMAJ 1999;160(7):1050-1.]
Zyban«, bupropion hydrochloride; 150mg sustained-release tablets: smoking cessation aid [product monograph]. Mississauga (ON): Glaxo Wellcome Inc.; 1999 Aug 19.
Table 1: Suspected adverse reactions to bupropion (Zyban«) reported in 407 reports* submitted to the CADRMP between Aug. 18, 1998, and Sept. 16, 1999...

 

Re: Media Qs about Wellburin aka Zyban, CamW?? and... ╗ dj

Posted by Cam W. on February 28, 2001, at 13:44:46

In reply to Media Qs about Wellburin aka Zyban, CamW?? and..., posted by dj on February 28, 2001, at 12:42:18

dj - This underscores the need to have a medical examination before undergoing any medication treatment for any disease state. Possible complicating factors range from undiagnosed heart &/or circulatory problems to concommitant stimulant use (eg from high dose pseudoephedrine to Ecstacy or amphetamine use). I'd be interested to hear of the toxicology report on this gentleman. I can't even count the number of times I have been told by patients that they have cleaned up their act, only to find that they have relapsed. It is tough to clean up one's act, especially without some sort of perceptual shift (eg cognitive-behavioral therapy, interpersonal therapy, group therapy, etc) and a real want to change. It is something that has to be actively worked at. I'm not saying that this guy didn't "clean-up his act", but I'd like to see the results of a hair analysis.

Aside from this, there are no absolutely safe medications. This is a given. Why did this guy not tell his doc of the rapid heartbeat with the Wellbutrin? If he did, did the doc do any testing of blood pressure, etc., to rule out heart problems? A racing heart with Wellbutrin, especially after the first couple of weeks of use is a noteworthy side effect. This should have been reported to the doctor, especially when accompanied with the stress of quitting smoking.

In most people, an mild increase in heart rate (usually transient with Wellbutrin use) does not adversely affect a person. People do have to take the responsibility of reporting any adverse side effects to their doctor, as much as the doctor needs to inquire of any side effects noticed with the meds.

The article stresses that we should also take responsibility for our treatments and not just let a doctor treat us. We have to be active partners in the treatment process.

Just my opinion - Cam

 

Re: Good comments ╗ Cam W.

Posted by dj on February 28, 2001, at 14:10:00

In reply to Re: Media Qs about Wellburin aka Zyban, CamW?? and... ╗ dj, posted by Cam W. on February 28, 2001, at 13:44:46

> The article stresses that we should also take responsibility for our treatments and not just let a doctor treat us. We have to be active >partners in the treatment process.

Amen,Cam! Active and well informed, though there is so much conflicting info. out there from some sources, it's hard for lay folk to sort through it by times, which is where helpful and insightful professionals like yourself make a huge difference in sorting through... unfortunately not all medical 'professionals' are as helpful or informative and the same with consumers - both of whom are sometimes focused on other priorities... so it goes...

BTW, a somewhat minor earthquake shook things up an hour ago and even more so in Seattle. If it picks up in intensity later, you may have beachfront property in Alberta, yet. ; )

Sante!

dj

BTW, do the hair analyses done in some health food stores have any validity or is that a pseudo-science application of the same or similar technology...??

 

Re: Media Qs about Wellburin aka Zyban, CamW?? and...

Posted by Sunnely on February 28, 2001, at 19:32:52

In reply to Media Qs about Wellburin aka Zyban, CamW?? and..., posted by dj on February 28, 2001, at 12:42:18

dj,

Like Cam, I think it's best to wait for the postmortem report. However, for the sake of discussion, and take for granted this unfortunate man indeed died from a serious adverse effect of Zyban per se, I can think of a couple of possibilities:

1. Some form of severe allergic reaction such as an anaphylactic shock leading to death. This is highly unlikely since he had been taking this drug for at least 10 days. Allergic reaction generally occurs upon first exposure to the allergen. This type of reaction is generally not dose-related.

2. On the other hand, toxic reaction usually occurs after several days of drug intake (or overdose). Granted that this individual did not intentional overdosed on Zyban, or was not taking other drugs that can interfere with the metabolism of Zyban, or did not have any medical condition that could interfere with the proper breakdown and elimination of the drug, one possibility (probably a long shot) is genetic polymorphism.

Zyban (Wellbutrin) is metabolized by several cytochrome enzymes. The parent compound itself (bupropion) is metabolized by CYP2B6 and CYP3A4. One of its active metabolites, hydroxybupropion is mainly metabolized by CYP2D6. It has been hypothesized that hydroxybupropion is more potent than the parent compound in boosting the dopamine and norepinephrine effect. (Both can cause cardiac stimulation.) Seven to 10 percent of the Caucasian population do not possess the enzyme CYP2D6. (I'm supposing this man was Caucasian.) They are genetically deficient of this enzyme. Without this enzyme, the hydroxybupropion is not being metabolized to inactive product. This then results in its greater bioavailability, greater blood concentrations, prolonged elimination half-life, exaggerated pharmacologic response, including toxic effect.

Bupropion (or its active metabolite) in excess can cause generalized seizures. The heart initially becomes tachycardic (fast heart beat) but eventually bradycardia (slowed heart beat) develops, and if not corrected immediately, asystolic cardiac arrest sets in. Aside from the toxicology exam, I would be interested to know this man's blood level of bupropion and its metabolites.

Someday, as the field of pharmacogenetics improve, genetic typing for deficiency of cytochrome enzymes will become a routine procedure to avoid unforseen toxic effects from medications. For those who are genetically deficient of a certain cytochrome enzyme, the dose can be adjusted accordingly, instead of following the "recommended" dosing regimen which could prove toxic, sometimes deadly, for these people.

Just my own 2 cents.

+++++++++++++++++++++++++++++++++++++++++++++

> The following article is from a Montreal newspaper and the info. after that is from the link cited at the end of the article.
>
> I took Wellbutrin for four months or so 1.5 years ago and don't recall any flagrant reactions and am considering taking it again. However I am curious what CamW. or Sunnely or informed others might have to say about the following published info. which raises questions but no clear answers, in the highlighted case at least.
>
> I'm wondering if the general reactions cited in Health Canada's "Canadian Adverse Drug Reaction Newsletter" are extraordinary for an AD or any medication for that matter?. There are no other ADs cited there, in the DRUGS OF CURRENT INTEREST section, that I recognize.
>
> dj
>
>
> From: http://www.montrealgazette.com/
>
> Monday 26 February 2001
>
> Kicking the habit: Can anti-smoking pill kill?
>
> JEFF HEINRICH
> The Gazette
>
> MARCOS TOWNSEND, GAZETTE / David Landry, found dead on the kitchen floor of his Plateau Mont Royal apartment, had been taking Wellbutrin after quitting smoking. Friends said the pills made his heart race.
>
> His name was David Landry, he was 26, and he was trying to quit smoking. But in the end it was his life, not just his habit, that got snuffed out.
>
> Did his anti-smoking medication kill him?
>
> His friends in Montreal and his family back home in Moncton, N.B., believe so, and a Quebec coroner is investigating the suspected link, adding to a long list of similar cases being probed worldwide.
>
> Landry was found dead on the kitchen floor of his Plateau Mont Royal apartment two weeks ago, a sponge by his side and a bottle of little purple pills in the adjacent bathroom.
>
> The pills were bupropion hydrochloride. Taken by more than one million Canadians and subsidized in Quebec under the province's drug-insurance plan, it's a stimulant used to treat depression or to help people stop smoking.
>
> It's sold under a couple of names: Wellbutrin and Zyban.
>
> Smokers pop two pills a day for three months, hoping they'll be one of the lucky one in three for whom the drug cuts the body's craving for nicotine, breaking the habit.
>
> Landry, a tattooed astrology buff and painter who ate vegetarian and made his living in telemarketing, had been on the medication for 10 days, and had doubled the dosage as prescribed after the first week.
>
> According to friends, the pills had made his heart race and his mood slightly euphoric. But figuring those were just normal side-effects of the drug, and adamant that he would quit smoking, he kept taking it.
>
> "There was nothing that really triggered any alarm in him or in us, his friends," said hairdresser Jenn Griffin, 24, whose family doctor prescribed Landry his Wellbutrin.
>
> "It was just the usual side-effects."
>
> Griffin found Landry's body in his Gilford St. flat the night of Feb. 11. Stunned, searching for an explanation, she leaped to the conclusion that the pills in the bathroom cupboard had been her friend's downfall.
>
> "There was no other explanation. He was healthy, he had no history of heart problems, just a bit of depression in his family. From the moment I found him, I knew it was the (Wellbutrin) that killed him."
>
> But the coroner won't yet go that far.
>
> "It's surprising when a young man of 26 dies suddenly and non-violently," said Francois Houle, of the coroner's office.
>
> "But until the police and coroner's investigations are complete, it's too early to say" whether the pills were the cause, he added.
>
> The drug's manufacturer, the pharmaceutical giant GlaxoSmithKline, denies any suggestion its product can cause death.
>
> "There has not been a direct link between Zyban and fatalities - it's unproven," said Carlo Mastrangelo, spokesman at Glaxo's Canadian headquarters in Mississauga, Ont.
>
> But there is no denying the controversy.
>
> In the three years since it started being marketed internationally as an aid to stop smoking, bupropion has been suspected as the cause of hundreds of cases of unwanted side-effects and even death.
>
> In several Western countries, including Canada, health authorities are monitoring so-called "adverse events" associated with the drug.
>
> Among the more severe side-effects reported have been seizures, strokes, heart attacks, psychotic episodes and depression. In Britain, Australia and Canada, Zyban has been suspected in at least 22 deaths.
>
> "There's a kind of panic right now about Zyban," said Marcel Boulanger, a retired anesthetist who runs the Montreal Heart Institute's smoking-cessation program.
>
> "It's true the drug has a number of undesirable effects; it's not a harmless drug," said Boulanger, an occasional paid consultant to Glaxo who has taught medical students how to prescribe it.
>
> But put in perspective, he added, the risk is very low. More than one million Canadians have taken the drug since it came on the market in mid-1998, but at last count only 407 Zyban users and 67 Wellbutrin users have had any adverse reaction.
>
> Health Canada statistics compiled in January 2000 show that 256 of those Zyban reactions were serious. They included three people who died of heart attacks; two had a history of heart disease.
>
> Because smokers are at risk of a lot of deadly and debilitating things anyway, and because quitting smoking itself can be stressful, it's hard to pinpoint Zyban as aggravating their condition - least of all causing death.
>
> Landry was a case in point.
>
> Like many in his circle in the bohemian Plateau, he liked to go to bars, drink, smoke a bit of pot, his friends say. And before he tried to quit, he was a half-a-pack-a-day cigarette smoker.
>
> While on his medication, however, he cleaned up his act. A few days before he died, for example, he declined an invitation from friends to go out drinking. He knew alcohol and bupropion don't mix.
>
> The drug's labeling carries other warnings: it can cause seizures in one patient per 1,000 and has milder side-effects, like insomnia, dry mouth and skin rashes. Those are the ones Glaxo emphasizes on its packaging.
>
> But now concerns over a link to fatal heart attacks and mental problems have put the company on the defensive, as it fends off a backlash by doctors and anti-smoking advocates who once hailed the drug.
>
> In Australia, where the drug went on sale last November, the Melbourne newspaper the Age said last week there have been 68 official reports of suspected adverse events, including 24 reports of psychological disturbances and one death - a patient who suffered a massive lung clot about three days after stopping Zyban.
>
> Psychiatrists and family doctors warned last Monday that the drug could trigger a psychotic episode in schizophrenics and should be used with caution. In England, the national Department of Health is also monitoring Zyban after receiving notification of 18 deaths possibly associated with the drug.
>
> Zyban has been approved for smoking-cessation in Canada, the United States, Australia, New Zealand and most European countries. Glaxo estimates that more than 15 million people worldwide have taken Zyban since it was first marketed in 1997. Last year in Canada, pharmacists filled out 1.2 million prescriptions for Zyban and Wellbutrin, totaling $70 million in retail sales, the drug statistics firm IMS Health Canada estimates.
>
> Landry was one of those who tried it. His bottle of Wellbutrin cost him $60. Until the coroner's report, it will be unclear whether he ultimately paid a much higher price: his life.
>
> "The take-home message for people thinking of taking a new medication is to always be on guard," said Mark Palayew, a respirologist at Jewish General Hospital. "Always beware and make sure you don't fit the profile of someone who shouldn't be taking that drug."
>
> - GlaxoSmithKline's corporate Web site for Zyban is www.zyban.com/
>
> - For details of problems with Zyban reported in Canada, consult Health Canada's Adverse Drug Reaction Newsletter of January 2000. It's on the Web at www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/publicat/adrv10n1_e.html
>
>
>
> Bupropion (Zyban«, sustained-release tablets): update
>
> Adverse drug reactions (ADRs) to Zyban« (marketed in Canada since August 1998) were previously reported in the April 1999 issue of this newsletter.1 The CADRMP continues to receive spontaneous ADR reports for Zyban« sustained-release tablets, and as of Sept. 16, 1999, received 407 reports (Table 1), of which 256 were serious. Also received were 67 reports for Wellbutrin SR«, another brand of sustained-release bupropion, which is indicated for the relief of symptoms of depression. These 2 drugs contain the same active ingredient, but because of their use in different patient populations this article will focus on Zyban« as indicated for smoking cessation. Although not all of the ADRs in Table 1 are currently listed in the product monograph, it is important to read the product monograph carefully to minimize the risk of ADRs.
>
> Among the cases reporting cardiovascular reactions were 3 deaths, including 2 from myocardial infarction (in a 52-year-old man1 and a woman in her 60s with a history of coronary artery disease) and 1 from cardiac arrest (in a 53-year-old man with a pulmonary embolism). In addition to the 2 cases of fatal myocardial infarction, there were 7 nonfatal cases of myocardial infarction (2 women, 5 men; age range 44-69 years). Three of these 7 patients had prior cardiovascular disease; another had unspecified risk factors.
>
> The CADRMP received 64 reports of convulsions or grand mal convulsions. Two of the grand mal convulsions were reported as status epilepticus. In one case, a 49-year-old woman had had a single seizure 25 years earlier, and in the other a woman of unknown age had had a single seizure 20 years before this event. Neither reported the use of concomitant medications. The events were reported to have resolved without sequelae in both instances. Among the 64 reports, 29 included the following risk factors for seizure: history of head injury (1); alcohol use (5); diabetes mellitus (4); history of seizure (7); and use of concomitant medications that may lower seizure threshold: antidepressants (4), mefloquine (1) and antipsychotics (1). There were 6 reports of patients who took Zyban« in other than the recommended dose. The risk of seizures with the use of bupropion is associated with a dose-dependent effect.2 Bupropion should be administered with extreme caution in patients at risk of seizures because of clinical conditions or concurrent medications.2
>
> Seven cases of hypoglycemia were reported. In 5 cases the patients were taking insulin concomitantly. Another case involved a Zyban« overdose. Three of the 7 patients also suffered convulsions; 2 of them were taking insulin. The current product monograph indicates that the use of buproprion in diabetic patients treated with oral hypoglycemic agents or insulin is associated with an increased risk of seizure.2
>
> There were 128 cases reporting predominantly allergic reactions. In an additional 35 cases allergic reactions were reported in combination with musculoskeletal disorders, including 14 cases of serum sickness (8 women and 6 men; age range 21-46, age unknown in 1 case). Four of the patients with serum sickness were admitted to hospital, and for 2 others the event was considered disabling. Four of the 14 cases of serum sickness were reported as serum-sickness-like syndrome.
>
> There were 52 cases in which psychiatric reactions were reported predominantly. Among these were 7 cases of suicidal ideation (Table 1) in which 2 of the patients had a history of depression. One case of suicide attempt was also reported.
>
> Sixteen reports of visual disturbances were received (8 women, 7 men, 1 sex unknown; age range 21-62 years). The following symptoms occurred: blurred vision, photosensitivity, dilated pupils, decreased vision, retinal vein occlusion, amblyopia, diplopia, difficulty reading, watery eyes, glaucoma, spots, conjunctivitis and myopia.
>
> Spontaneous postmarketing ADR reports constitute one of the key elements used by the TPP to detect new signals and update the product monograph and labelling information. The TPP continues to work with the manufacturer to re-evaluate and update the safety profile of Zyban«.
>
> Written by: Heather Dunlop, BNSc, MLIS, Bureau of Drug Surveillance.
>
> References
>
> HÚbert S. Bupropion (Zyban«, sustained-release tablets): reported adverse reactions. Can Adverse Drug Reaction Newsl 1999;9(2):1-2. [Also in CMAJ 1999;160(7):1050-1.]
> Zyban«, bupropion hydrochloride; 150mg sustained-release tablets: smoking cessation aid [product monograph]. Mississauga (ON): Glaxo Wellcome Inc.; 1999 Aug 19.
> Table 1: Suspected adverse reactions to bupropion (Zyban«) reported in 407 reports* submitted to the CADRMP between Aug. 18, 1998, and Sept. 16, 1999...

 

Re: Another thoughful response... ╗ Sunnely

Posted by dj on February 28, 2001, at 20:40:31

In reply to Re: Media Qs about Wellburin aka Zyban, CamW?? and..., posted by Sunnely on February 28, 2001, at 19:32:52

Thanks Sunnely. If I spy anything on the post-mortem I'll post it here and encourage others to do the same!

 

Re: Media Qs about Wellburin aka Zyban, CamW?? and... ╗ Cam W.

Posted by kate9999 on February 28, 2001, at 23:29:56

In reply to Re: Media Qs about Wellburin aka Zyban, CamW?? and... ╗ dj, posted by Cam W. on February 28, 2001, at 13:44:46

I'm kind of surprised by what you're saying - I did research on Wellbutrin because my mother who is in her late 60s is on it and at one point had shortness of breath (which the doctor ascribed to anxiety not a cardiovascular side effect).

The literature I read (a review of the safety of ad's for older patients) said that Wellbutrin had no known effect on blood pressure or heart function. At the time that put my mind at ease.

Is this not true? Is there a known or even speculated cardiovascular risk from taking Wellbutrin? More so than with other AD's?

> dj - This underscores the need to have a medical examination before undergoing any medication treatment for any disease state. Possible complicating factors range from undiagnosed heart &/or circulatory problems to concommitant stimulant use (eg from high dose pseudoephedrine to Ecstacy or amphetamine use). I'd be interested to hear of the toxicology report on this gentleman. I can't even count the number of times I have been told by patients that they have cleaned up their act, only to find that they have relapsed. It is tough to clean up one's act, especially without some sort of perceptual shift (eg cognitive-behavioral therapy, interpersonal therapy, group therapy, etc) and a real want to change. It is something that has to be actively worked at. I'm not saying that this guy didn't "clean-up his act", but I'd like to see the results of a hair analysis.
>
> Aside from this, there are no absolutely safe medications. This is a given. Why did this guy not tell his doc of the rapid heartbeat with the Wellbutrin? If he did, did the doc do any testing of blood pressure, etc., to rule out heart problems? A racing heart with Wellbutrin, especially after the first couple of weeks of use is a noteworthy side effect. This should have been reported to the doctor, especially when accompanied with the stress of quitting smoking.
>
> In most people, an mild increase in heart rate (usually transient with Wellbutrin use) does not adversely affect a person. People do have to take the responsibility of reporting any adverse side effects to their doctor, as much as the doctor needs to inquire of any side effects noticed with the meds.
>
> The article stresses that we should also take responsibility for our treatments and not just let a doctor treat us. We have to be active partners in the treatment process.
>
> Just my opinion - Cam

 

Re: Media Qs about Wellburin aka Zyban, CamW?? and... ╗ kate9999

Posted by Cam W. on March 1, 2001, at 0:37:52

In reply to Re: Media Qs about Wellburin aka Zyban, CamW?? and... ╗ Cam W., posted by kate9999 on February 28, 2001, at 23:29:56

Kate - Wellbutrin is structurally similar to the stimulant diet aid Tenuate. It's product monograph lists tachycardia (increased heart rate) and palpitations as side effects. The SSRIs have a similar incidence (2%-3%). The SSRIs are considered safer for the elderly as well.

The SOB your mother experienced was probably anxiety-related, as the doc said, as this is a more common side effect than either palpitations or tachycardia.

The monograph also states that the elderly may be more sensitive to the cardiovascular side effects. Whether this is clinically significant in a healthy elderly person is debatable.

Still, Wellbutrin is much safer in the elderly than the MAOIs, TCAs and probably Effexor for the heart. It is comparable to the SSRIs in terms of safety profile for the elderly.

The product monograph for Wellbutrin can be found in the CPS (in Canada) or the PDR (in the U.S.).

Hope this helps - Cam


> I'm kind of surprised by what you're saying - I did research on Wellbutrin because my mother who is in her late 60s is on it and at one point had shortness of breath (which the doctor ascribed to anxiety not a cardiovascular side effect).
>
> The literature I read (a review of the safety of ad's for older patients) said that Wellbutrin had no known effect on blood pressure or heart function. At the time that put my mind at ease.
>
> Is this not true? Is there a known or even speculated cardiovascular risk from taking Wellbutrin? More so than with other AD's?
>

 

Re: Media Qs about Wellburin aka Zyban, CamW?? and...

Posted by kate9999 on March 4, 2001, at 4:06:15

In reply to Re: Media Qs about Wellburin aka Zyban, CamW?? and... ╗ kate9999, posted by Cam W. on March 1, 2001, at 0:37:52

Thanks, Cam. This was very helpful.

> Kate - Wellbutrin is structurally similar to the stimulant diet aid Tenuate. It's product monograph lists tachycardia (increased heart rate) and palpitations as side effects. The SSRIs have a similar incidence (2%-3%). The SSRIs are considered safer for the elderly as well.
>
> The SOB your mother experienced was probably anxiety-related, as the doc said, as this is a more common side effect than either palpitations or tachycardia.
>
> The monograph also states that the elderly may be more sensitive to the cardiovascular side effects. Whether this is clinically significant in a healthy elderly person is debatable.
>
> Still, Wellbutrin is much safer in the elderly than the MAOIs, TCAs and probably Effexor for the heart. It is comparable to the SSRIs in terms of safety profile for the elderly.
>
> The product monograph for Wellbutrin can be found in the CPS (in Canada) or the PDR (in the U.S.).
>
> Hope this helps - Cam
>
>
>
>
> > I'm kind of surprised by what you're saying - I did research on Wellbutrin because my mother who is in her late 60s is on it and at one point had shortness of breath (which the doctor ascribed to anxiety not a cardiovascular side effect).
> >
> > The literature I read (a review of the safety of ad's for older patients) said that Wellbutrin had no known effect on blood pressure or heart function. At the time that put my mind at ease.
> >
> > Is this not true? Is there a known or even speculated cardiovascular risk from taking Wellbutrin? More so than with other AD's?
> >

 

Re: More Media Qs about Zyban...

Posted by dj on March 24, 2001, at 13:04:38

In reply to Re: Media Qs about Wellburin aka Zyban, CamW?? and..., posted by Sunnely on February 28, 2001, at 19:32:52

> dj,
>
> Like Cam, I think it's best to wait for the postmortem report

I went back to the Montreal Gazette on-line today to see if there was any info. on the post-mortem on the above-noted death. There wasn't but there was the following article. Make of it what you shall...


Friday 2 March 2001

Debating Zyban's safety


Role of anti-smoking drug being probed in 24 deaths
JEFF HEINRICH
The Gazette



DAVE SIDAWAY, GAZETTE / Charles Hammock's widow, Peggy-Ann, wants Zyban off the market.


In the database of the world's largest drug company, the premature death of Charles Hammock at age 48 is listed as Adverse Event No. CD/00/4960.

A Bombardier aircraft upholsterer who lived in Lachine, Hammock died suddenly the morning of Aug. 17, 1999, 10 days after starting treatment with Zyban, the anti-smoking pill.

His widow and five children suspect the drug killed him.

His family doctor reported a possible connection. But a Quebec coroner last March concluded Hammock had died of natural causes: fatal arrhythmia.

What led to those abnormal heart rhythms, which were serious enough to cause cardiac arrest, severe enough to cause Hammock to collapse on the job and die?

Was it the drug? Was it because Hammock, a pack-a-day Belvedere smoker since his teens, already ran a high risk of heart failure? Or was it a symptom of his withdrawing from a lifelong addiction to nicotine?

On those kinds of questions hinges the worldwide debate over the safety of Zyban, a top-selling medication that was launched in 1997 and is used by one million Canadians and 14 million other people worldwide.

The drug is being investigated as the possible cause of at least four other deaths in Canada, including that of 26-year-old Montrealer David Landry in February, as well as of 18 deaths in Britain and one in Australia.

GlaxoSmithKline, the British-based pharmaceutical giant that makes Zyban, denies any proven link so far between its drug and the fatalities. So do investigators at Health Canada and other countries' health authorities.

What makes many of the cases disturbing is how relatively healthy - for smokers - some of the patients like Hammock were before they started taking Zyban, and how sudden and unexpected their deaths were.

Zyban's active ingredient, bupropion hydrochloride, a kind of anti-depressant, also is marketed to psychiatric patients (as well as some smokers) under the brand name Wellbutrin.

A stimulant, it works by changing the balance of chemicals in the brain to reduce a person's craving for nicotine. A typical treatment lasts three months, with the patient quitting smoking after the first week.

Studies suggest one in three patients on Zyban remains off the weed even a year later. Hammock didn't get that far.

"Charlie quit smoking, but unfortunately he had to quit breathing to do it," his widow, Peggy-Ann Scott-Hammock, quipped bitterly in an interview this week, lamenting the sudden end of a marriage that lasted 31 years.

"It was my worst nightmare. You say goodbye to your husband in the morning on his way to work, and he doesn't come home."

A trim 159 pounds, Hammock had an otherwise clean bill of health before he started taking Zyban, his medical chart shows: normal blood pressure, low cholesterol levels, no history of heart or lung problems.

After a checkup on July 28, 1999, and a series of routine lab tests, his family doctor pronounced him fit enough "to live to 100," Scott-Hammock told The Gazette.

Hammock had been encouraged to quit smoking with Zyban after hearing how well it had helped a co-worker at Bombardier break her habit. And he'd seen ads for the product on U.S. cable TV.

Ten days after his physical, he got his prescription filled. But after a few days of popping the little purple Zyban pills, first once, then twice every 24 hours, something went wrong.

"He started telling me how peculiar he felt," said Scott-Hammock, who works as the daycare supervisor at Meadowbrook elementary school in Lachine.

"As a family, we noticed he was majorly agitated. I kept saying to him, 'Charlie, maybe you shouldn't be taking this Zyban.' But he thought the side-effects would wear off after a few days, so he stayed on it."

The night before he died, there was a major blowup at the family supper table. Hammock was testy, irritable, far more than he'd ever been in previous attempts to quit smoking. "I said, 'Calm down, you're going to have a stroke,' " Scott-Hammock recounted.

Like other anti-depressant drugs, Zyban carries a significant risk of seizures: one in 1,000 people will have fits or go into convulsions as result of taking it.

According to Glaxo's lengthy monograph for Zyban, 2 per cent of patients will also experience some heart palpitations while on it. But the jury is out on whether those palpitations can be deadly.

The monograph only warns doctors to be careful prescribing the drug to patients who've had a recent heart attack and other cardiac problems, saying studies have yet to prove its safety for those people.

Early on the morning of his death, around 8:30 a.m., Hammock phoned his wife from work to say he'd had a bad dizzy spell. He also told his supervisor he had a headache, the coroner's report shows.

Less than two hours later, he collapsed in Dorval. At 10:20 his supervisor found him unconscious, lying on the floor of the Canadair Global Express jet on which he'd been working.

His heart was beating but he had no pulse and he wasn't breathing.

An Urgences-Sante technician tried to revive him with a defibrillator, but it was too late. After an ambulance ride to Sacre Coeur Hospital, Hammock was pronounced dead.

His family was left in shock, searching for answers. They called his doctor. They called Glaxo Canada's telephone helpline and talked to a company nurse. The closest they got to an explanation was two months ago, when another official called back.

"The woman told me my husband's case was now registered in an international database of adverse events to Zyban, and that the company was accumulating evidence," Scott-Hammock recalled.

"I told her that wasn't good enough. I told her, 'How many people are going to die before you pull this drug from the market? When will we as consumers know there's something wrong with this drug?' "

The Glaxo official pointed out that as a smoker Hammock had been at risk of heart disease. " 'But he didn't have heart disease, and he didn't die of it, either,' " the widow remembers responding. " 'He went from perfectly healthy to dead in 10 days. Explain that.' "

This week, Glaxo Canada's chief medical officer tried.

"It's always a difficult call" whether the death of a patient like Hammock "was due to an underlying problem or due to the drug," said Dr. Anne Phillips, an infectious-disease specialist who is the company's vice-president of research and development.

"People who smoke are at greatly increased risk: they're about five times more likely than non-smokers to have a heart attack or heart problems," she said from Glaxo Canada headquarters in Mississauga, Ont.

"So these events occurring in a patient population which is taking the medication doesn't necessarily, of course, implicate the medication as the cause."

According to Health Canada data dating back to September 1999 - the most recent it and the company say are available - there have been 407 adverse events related to Zyban and 67 related to Wellbutrin.

Of the Zyban events, 312 involved three deaths, seven non-fatal heart attacks, 64 convulsions or seizures, seven cases of hypoglycemia (low blood sugar), 163 allergic reactions, 52 psychiatric reactions (including one suicide attempt), and 16 reports of vision problems.

Health Canada's Therapeutic Products Program, which monitors drug safety, "continues to work with the manufacturer to re-evaluate and update the safety profile of Zyban," it said in a January 2000 report.

Asked about the hundreds of adverse events, Glaxo's Phillips said she wasn't surprised.

"The more people that take any product, even Aspirin, the more side-effects or adverse events are going to be reported," she said.

"When you have that number of people (more than one million Canadians on Zyban) taking anything, even taking a glass of water, some are going to report different adverse events."

What about possible effects on the heart? Shouldn't Zyban users be warned about palpitations - and stop taking the drug at the first sign of them?

"Not necessarily," Phillips said.

"I mean, you have to remember the context in which this product is being used: during withdrawal from an addicting substance (nicotine). And one of the side-effects of withdrawal is often palpitations."

Coming off a nicotine addiction is never pleasant, she added. "It tends to cause a series of physical symptoms: anxiety, palpitations, insomnia are all very common withdrawal syndromes."

Aren't the unexpected deaths of younger Zyban patients like Hammock and especially the 26-year-old Landry last month rather unusual?

Not really, Phillips said.

"We have young people who die suddenly all the time. You hear reports of kids in the gym playing basketball or whatever dropping dead. Young people do die sudden death."

Will the survivors of Zyban patients like Hammock never get a definitive answer? Will they never know for sure whether Zyban did or did not kill their loved one?

Perhaps not, Phillips said.

Just as the families of cancer victims can't know if the drugs in chemotherapy did more harm than good, those with experience with Zyban may never get the answer they're looking for.

"Cancer drugs are just as hard to decide," Phillips noted. "Are adverse events a side-effect of the medication or a progression of the malignancy? We're always faced with these difficult situations."

Scott-Hammock can't shed her suspicions, though. Zyban and Wellbutrin are a $70-million-a-year business for Glaxo in Canada.

If the products are tarnished by safety concerns, the firm stock could take a hit.

"They may be watching the value of their stock," she said.

"But it seems to me that when there are as many sudden deaths as this, Glaxo should be erring on the side of caution and pulling Zyban off the shelves."

For now, Adverse Event No. CD/00/4960 languishes in an international registry, part of a puzzle, perhaps, or simply a footnote in the controversial history of a popular drug.

"I'll be sure to put that on his tombstone," his widow said sardonically. "'Here lies my husband, part of the evidence in an international database.' I'm sure Charlie would like that."

 

Re: More Media Qs about Zyban...

Posted by michael on March 24, 2001, at 14:27:44

In reply to Re: More Media Qs about Zyban..., posted by dj on March 24, 2001, at 13:04:38

Okay, three quick questions...

The first two specifically related to the article in the previous post (or see the post below):

1) What's up with "His heart was beating but he had no pulse ..." Does that make sense? Is that just saying that his heart was beating very weakly?

2) What's up with the following quote which directly follow the previous quote, "An Urgences-Sante technician tried to revive him with a defibrillator, but it was too late." If his heart is beating, are you supposed to use a defribillator?

I'm clearly not a doctor or anything close to one, so maybe that stuff makes sense, but it just seemed illogical when I read it.

3) The real question that I'm curious about though, is whether all of the suspected bupropion-related-deaths are related to zyban/smoking, or if some are related to wellbutrin/psych use of the drug? (of course, there could be some overlap, as in my case)

Fwiw, I'm not concerned about my taking the drug, I've done it for a long time, and am comfortable with it - I'm just curious. Anyone know?

> > dj,
> >
> > Like Cam, I think it's best to wait for the postmortem report
>
> I went back to the Montreal Gazette on-line today to see if there was any info. on the post-mortem on the above-noted death. There wasn't but there was the following article. Make of it what you shall...
>
>
> Friday 2 March 2001
>
> Debating Zyban's safety
>
>
> Role of anti-smoking drug being probed in 24 deaths
> JEFF HEINRICH
> The Gazette
>
>
>
> DAVE SIDAWAY, GAZETTE / Charles Hammock's widow, Peggy-Ann, wants Zyban off the market.
>
>
> In the database of the world's largest drug company, the premature death of Charles Hammock at age 48 is listed as Adverse Event No. CD/00/4960.
>
> A Bombardier aircraft upholsterer who lived in Lachine, Hammock died suddenly the morning of Aug. 17, 1999, 10 days after starting treatment with Zyban, the anti-smoking pill.
>
> His widow and five children suspect the drug killed him.
>
> His family doctor reported a possible connection. But a Quebec coroner last March concluded Hammock had died of natural causes: fatal arrhythmia.
>
> What led to those abnormal heart rhythms, which were serious enough to cause cardiac arrest, severe enough to cause Hammock to collapse on the job and die?
>
> Was it the drug? Was it because Hammock, a pack-a-day Belvedere smoker since his teens, already ran a high risk of heart failure? Or was it a symptom of his withdrawing from a lifelong addiction to nicotine?
>
> On those kinds of questions hinges the worldwide debate over the safety of Zyban, a top-selling medication that was launched in 1997 and is used by one million Canadians and 14 million other people worldwide.
>
> The drug is being investigated as the possible cause of at least four other deaths in Canada, including that of 26-year-old Montrealer David Landry in February, as well as of 18 deaths in Britain and one in Australia.
>
> GlaxoSmithKline, the British-based pharmaceutical giant that makes Zyban, denies any proven link so far between its drug and the fatalities. So do investigators at Health Canada and other countries' health authorities.
>
> What makes many of the cases disturbing is how relatively healthy - for smokers - some of the patients like Hammock were before they started taking Zyban, and how sudden and unexpected their deaths were.
>
> Zyban's active ingredient, bupropion hydrochloride, a kind of anti-depressant, also is marketed to psychiatric patients (as well as some smokers) under the brand name Wellbutrin.
>
> A stimulant, it works by changing the balance of chemicals in the brain to reduce a person's craving for nicotine. A typical treatment lasts three months, with the patient quitting smoking after the first week.
>
> Studies suggest one in three patients on Zyban remains off the weed even a year later. Hammock didn't get that far.
>
> "Charlie quit smoking, but unfortunately he had to quit breathing to do it," his widow, Peggy-Ann Scott-Hammock, quipped bitterly in an interview this week, lamenting the sudden end of a marriage that lasted 31 years.
>
> "It was my worst nightmare. You say goodbye to your husband in the morning on his way to work, and he doesn't come home."
>
> A trim 159 pounds, Hammock had an otherwise clean bill of health before he started taking Zyban, his medical chart shows: normal blood pressure, low cholesterol levels, no history of heart or lung problems.
>
> After a checkup on July 28, 1999, and a series of routine lab tests, his family doctor pronounced him fit enough "to live to 100," Scott-Hammock told The Gazette.
>
> Hammock had been encouraged to quit smoking with Zyban after hearing how well it had helped a co-worker at Bombardier break her habit. And he'd seen ads for the product on U.S. cable TV.
>
> Ten days after his physical, he got his prescription filled. But after a few days of popping the little purple Zyban pills, first once, then twice every 24 hours, something went wrong.
>
> "He started telling me how peculiar he felt," said Scott-Hammock, who works as the daycare supervisor at Meadowbrook elementary school in Lachine.
>
> "As a family, we noticed he was majorly agitated. I kept saying to him, 'Charlie, maybe you shouldn't be taking this Zyban.' But he thought the side-effects would wear off after a few days, so he stayed on it."
>
> The night before he died, there was a major blowup at the family supper table. Hammock was testy, irritable, far more than he'd ever been in previous attempts to quit smoking. "I said, 'Calm down, you're going to have a stroke,' " Scott-Hammock recounted.
>
> Like other anti-depressant drugs, Zyban carries a significant risk of seizures: one in 1,000 people will have fits or go into convulsions as result of taking it.
>
> According to Glaxo's lengthy monograph for Zyban, 2 per cent of patients will also experience some heart palpitations while on it. But the jury is out on whether those palpitations can be deadly.
>
> The monograph only warns doctors to be careful prescribing the drug to patients who've had a recent heart attack and other cardiac problems, saying studies have yet to prove its safety for those people.
>
> Early on the morning of his death, around 8:30 a.m., Hammock phoned his wife from work to say he'd had a bad dizzy spell. He also told his supervisor he had a headache, the coroner's report shows.
>
> Less than two hours later, he collapsed in Dorval. At 10:20 his supervisor found him unconscious, lying on the floor of the Canadair Global Express jet on which he'd been working.
>
> His heart was beating but he had no pulse and he wasn't breathing.
>
> An Urgences-Sante technician tried to revive him with a defibrillator, but it was too late. After an ambulance ride to Sacre Coeur Hospital, Hammock was pronounced dead.
>
> His family was left in shock, searching for answers. They called his doctor. They called Glaxo Canada's telephone helpline and talked to a company nurse. The closest they got to an explanation was two months ago, when another official called back.
>
> "The woman told me my husband's case was now registered in an international database of adverse events to Zyban, and that the company was accumulating evidence," Scott-Hammock recalled.
>
> "I told her that wasn't good enough. I told her, 'How many people are going to die before you pull this drug from the market? When will we as consumers know there's something wrong with this drug?' "
>
> The Glaxo official pointed out that as a smoker Hammock had been at risk of heart disease. " 'But he didn't have heart disease, and he didn't die of it, either,' " the widow remembers responding. " 'He went from perfectly healthy to dead in 10 days. Explain that.' "
>
> This week, Glaxo Canada's chief medical officer tried.
>
> "It's always a difficult call" whether the death of a patient like Hammock "was due to an underlying problem or due to the drug," said Dr. Anne Phillips, an infectious-disease specialist who is the company's vice-president of research and development.
>
> "People who smoke are at greatly increased risk: they're about five times more likely than non-smokers to have a heart attack or heart problems," she said from Glaxo Canada headquarters in Mississauga, Ont.
>
> "So these events occurring in a patient population which is taking the medication doesn't necessarily, of course, implicate the medication as the cause."
>
> According to Health Canada data dating back to September 1999 - the most recent it and the company say are available - there have been 407 adverse events related to Zyban and 67 related to Wellbutrin.
>
> Of the Zyban events, 312 involved three deaths, seven non-fatal heart attacks, 64 convulsions or seizures, seven cases of hypoglycemia (low blood sugar), 163 allergic reactions, 52 psychiatric reactions (including one suicide attempt), and 16 reports of vision problems.
>
> Health Canada's Therapeutic Products Program, which monitors drug safety, "continues to work with the manufacturer to re-evaluate and update the safety profile of Zyban," it said in a January 2000 report.
>
> Asked about the hundreds of adverse events, Glaxo's Phillips said she wasn't surprised.
>
> "The more people that take any product, even Aspirin, the more side-effects or adverse events are going to be reported," she said.
>
> "When you have that number of people (more than one million Canadians on Zyban) taking anything, even taking a glass of water, some are going to report different adverse events."
>
> What about possible effects on the heart? Shouldn't Zyban users be warned about palpitations - and stop taking the drug at the first sign of them?
>
> "Not necessarily," Phillips said.
>
> "I mean, you have to remember the context in which this product is being used: during withdrawal from an addicting substance (nicotine). And one of the side-effects of withdrawal is often palpitations."
>
> Coming off a nicotine addiction is never pleasant, she added. "It tends to cause a series of physical symptoms: anxiety, palpitations, insomnia are all very common withdrawal syndromes."
>
> Aren't the unexpected deaths of younger Zyban patients like Hammock and especially the 26-year-old Landry last month rather unusual?
>
> Not really, Phillips said.
>
> "We have young people who die suddenly all the time. You hear reports of kids in the gym playing basketball or whatever dropping dead. Young people do die sudden death."
>
> Will the survivors of Zyban patients like Hammock never get a definitive answer? Will they never know for sure whether Zyban did or did not kill their loved one?
>
> Perhaps not, Phillips said.
>
> Just as the families of cancer victims can't know if the drugs in chemotherapy did more harm than good, those with experience with Zyban may never get the answer they're looking for.
>
> "Cancer drugs are just as hard to decide," Phillips noted. "Are adverse events a side-effect of the medication or a progression of the malignancy? We're always faced with these difficult situations."
>
> Scott-Hammock can't shed her suspicions, though. Zyban and Wellbutrin are a $70-million-a-year business for Glaxo in Canada.
>
> If the products are tarnished by safety concerns, the firm stock could take a hit.
>
> "They may be watching the value of their stock," she said.
>
> "But it seems to me that when there are as many sudden deaths as this, Glaxo should be erring on the side of caution and pulling Zyban off the shelves."
>
> For now, Adverse Event No. CD/00/4960 languishes in an international registry, part of a puzzle, perhaps, or simply a footnote in the controversial history of a popular drug.
>
> "I'll be sure to put that on his tombstone," his widow said sardonically. "'Here lies my husband, part of the evidence in an international database.' I'm sure Charlie would like that."

 

Thanks for the update dj (np)

Posted by Cam W. on March 24, 2001, at 15:12:31

In reply to Re: More Media Qs about Zyban..., posted by dj on March 24, 2001, at 13:04:38

> > dj,
> >
> > Like Cam, I think it's best to wait for the postmortem report
>
> I went back to the Montreal Gazette on-line today to see if there was any info. on the post-mortem on the above-noted death. There wasn't but there was the following article. Make of it what you shall...
>
>
> Friday 2 March 2001
>
> Debating Zyban's safety
>
>
> Role of anti-smoking drug being probed in 24 deaths
> JEFF HEINRICH
> The Gazette
>
>
>
> DAVE SIDAWAY, GAZETTE / Charles Hammock's widow, Peggy-Ann, wants Zyban off the market.
>
>
> In the database of the world's largest drug company, the premature death of Charles Hammock at age 48 is listed as Adverse Event No. CD/00/4960.
>
> A Bombardier aircraft upholsterer who lived in Lachine, Hammock died suddenly the morning of Aug. 17, 1999, 10 days after starting treatment with Zyban, the anti-smoking pill.
>
> His widow and five children suspect the drug killed him.
>
> His family doctor reported a possible connection. But a Quebec coroner last March concluded Hammock had died of natural causes: fatal arrhythmia.
>
> What led to those abnormal heart rhythms, which were serious enough to cause cardiac arrest, severe enough to cause Hammock to collapse on the job and die?
>
> Was it the drug? Was it because Hammock, a pack-a-day Belvedere smoker since his teens, already ran a high risk of heart failure? Or was it a symptom of his withdrawing from a lifelong addiction to nicotine?
>
> On those kinds of questions hinges the worldwide debate over the safety of Zyban, a top-selling medication that was launched in 1997 and is used by one million Canadians and 14 million other people worldwide.
>
> The drug is being investigated as the possible cause of at least four other deaths in Canada, including that of 26-year-old Montrealer David Landry in February, as well as of 18 deaths in Britain and one in Australia.
>
> GlaxoSmithKline, the British-based pharmaceutical giant that makes Zyban, denies any proven link so far between its drug and the fatalities. So do investigators at Health Canada and other countries' health authorities.
>
> What makes many of the cases disturbing is how relatively healthy - for smokers - some of the patients like Hammock were before they started taking Zyban, and how sudden and unexpected their deaths were.
>
> Zyban's active ingredient, bupropion hydrochloride, a kind of anti-depressant, also is marketed to psychiatric patients (as well as some smokers) under the brand name Wellbutrin.
>
> A stimulant, it works by changing the balance of chemicals in the brain to reduce a person's craving for nicotine. A typical treatment lasts three months, with the patient quitting smoking after the first week.
>
> Studies suggest one in three patients on Zyban remains off the weed even a year later. Hammock didn't get that far.
>
> "Charlie quit smoking, but unfortunately he had to quit breathing to do it," his widow, Peggy-Ann Scott-Hammock, quipped bitterly in an interview this week, lamenting the sudden end of a marriage that lasted 31 years.
>
> "It was my worst nightmare. You say goodbye to your husband in the morning on his way to work, and he doesn't come home."
>
> A trim 159 pounds, Hammock had an otherwise clean bill of health before he started taking Zyban, his medical chart shows: normal blood pressure, low cholesterol levels, no history of heart or lung problems.
>
> After a checkup on July 28, 1999, and a series of routine lab tests, his family doctor pronounced him fit enough "to live to 100," Scott-Hammock told The Gazette.
>
> Hammock had been encouraged to quit smoking with Zyban after hearing how well it had helped a co-worker at Bombardier break her habit. And he'd seen ads for the product on U.S. cable TV.
>
> Ten days after his physical, he got his prescription filled. But after a few days of popping the little purple Zyban pills, first once, then twice every 24 hours, something went wrong.
>
> "He started telling me how peculiar he felt," said Scott-Hammock, who works as the daycare supervisor at Meadowbrook elementary school in Lachine.
>
> "As a family, we noticed he was majorly agitated. I kept saying to him, 'Charlie, maybe you shouldn't be taking this Zyban.' But he thought the side-effects would wear off after a few days, so he stayed on it."
>
> The night before he died, there was a major blowup at the family supper table. Hammock was testy, irritable, far more than he'd ever been in previous attempts to quit smoking. "I said, 'Calm down, you're going to have a stroke,' " Scott-Hammock recounted.
>
> Like other anti-depressant drugs, Zyban carries a significant risk of seizures: one in 1,000 people will have fits or go into convulsions as result of taking it.
>
> According to Glaxo's lengthy monograph for Zyban, 2 per cent of patients will also experience some heart palpitations while on it. But the jury is out on whether those palpitations can be deadly.
>
> The monograph only warns doctors to be careful prescribing the drug to patients who've had a recent heart attack and other cardiac problems, saying studies have yet to prove its safety for those people.
>
> Early on the morning of his death, around 8:30 a.m., Hammock phoned his wife from work to say he'd had a bad dizzy spell. He also told his supervisor he had a headache, the coroner's report shows.
>
> Less than two hours later, he collapsed in Dorval. At 10:20 his supervisor found him unconscious, lying on the floor of the Canadair Global Express jet on which he'd been working.
>
> His heart was beating but he had no pulse and he wasn't breathing.
>
> An Urgences-Sante technician tried to revive him with a defibrillator, but it was too late. After an ambulance ride to Sacre Coeur Hospital, Hammock was pronounced dead.
>
> His family was left in shock, searching for answers. They called his doctor. They called Glaxo Canada's telephone helpline and talked to a company nurse. The closest they got to an explanation was two months ago, when another official called back.
>
> "The woman told me my husband's case was now registered in an international database of adverse events to Zyban, and that the company was accumulating evidence," Scott-Hammock recalled.
>
> "I told her that wasn't good enough. I told her, 'How many people are going to die before you pull this drug from the market? When will we as consumers know there's something wrong with this drug?' "
>
> The Glaxo official pointed out that as a smoker Hammock had been at risk of heart disease. " 'But he didn't have heart disease, and he didn't die of it, either,' " the widow remembers responding. " 'He went from perfectly healthy to dead in 10 days. Explain that.' "
>
> This week, Glaxo Canada's chief medical officer tried.
>
> "It's always a difficult call" whether the death of a patient like Hammock "was due to an underlying problem or due to the drug," said Dr. Anne Phillips, an infectious-disease specialist who is the company's vice-president of research and development.
>
> "People who smoke are at greatly increased risk: they're about five times more likely than non-smokers to have a heart attack or heart problems," she said from Glaxo Canada headquarters in Mississauga, Ont.
>
> "So these events occurring in a patient population which is taking the medication doesn't necessarily, of course, implicate the medication as the cause."
>
> According to Health Canada data dating back to September 1999 - the most recent it and the company say are available - there have been 407 adverse events related to Zyban and 67 related to Wellbutrin.
>
> Of the Zyban events, 312 involved three deaths, seven non-fatal heart attacks, 64 convulsions or seizures, seven cases of hypoglycemia (low blood sugar), 163 allergic reactions, 52 psychiatric reactions (including one suicide attempt), and 16 reports of vision problems.
>
> Health Canada's Therapeutic Products Program, which monitors drug safety, "continues to work with the manufacturer to re-evaluate and update the safety profile of Zyban," it said in a January 2000 report.
>
> Asked about the hundreds of adverse events, Glaxo's Phillips said she wasn't surprised.
>
> "The more people that take any product, even Aspirin, the more side-effects or adverse events are going to be reported," she said.
>
> "When you have that number of people (more than one million Canadians on Zyban) taking anything, even taking a glass of water, some are going to report different adverse events."
>
> What about possible effects on the heart? Shouldn't Zyban users be warned about palpitations - and stop taking the drug at the first sign of them?
>
> "Not necessarily," Phillips said.
>
> "I mean, you have to remember the context in which this product is being used: during withdrawal from an addicting substance (nicotine). And one of the side-effects of withdrawal is often palpitations."
>
> Coming off a nicotine addiction is never pleasant, she added. "It tends to cause a series of physical symptoms: anxiety, palpitations, insomnia are all very common withdrawal syndromes."
>
> Aren't the unexpected deaths of younger Zyban patients like Hammock and especially the 26-year-old Landry last month rather unusual?
>
> Not really, Phillips said.
>
> "We have young people who die suddenly all the time. You hear reports of kids in the gym playing basketball or whatever dropping dead. Young people do die sudden death."
>
> Will the survivors of Zyban patients like Hammock never get a definitive answer? Will they never know for sure whether Zyban did or did not kill their loved one?
>
> Perhaps not, Phillips said.
>
> Just as the families of cancer victims can't know if the drugs in chemotherapy did more harm than good, those with experience with Zyban may never get the answer they're looking for.
>
> "Cancer drugs are just as hard to decide," Phillips noted. "Are adverse events a side-effect of the medication or a progression of the malignancy? We're always faced with these difficult situations."
>
> Scott-Hammock can't shed her suspicions, though. Zyban and Wellbutrin are a $70-million-a-year business for Glaxo in Canada.
>
> If the products are tarnished by safety concerns, the firm stock could take a hit.
>
> "They may be watching the value of their stock," she said.
>
> "But it seems to me that when there are as many sudden deaths as this, Glaxo should be erring on the side of caution and pulling Zyban off the shelves."
>
> For now, Adverse Event No. CD/00/4960 languishes in an international registry, part of a puzzle, perhaps, or simply a footnote in the controversial history of a popular drug.
>
> "I'll be sure to put that on his tombstone," his widow said sardonically. "'Here lies my husband, part of the evidence in an international database.' I'm sure Charlie would like that."

 

Re: Media Qs about Wellburin aka Zyban, CamW?? and...

Posted by DGP on July 31, 2002, at 22:17:51

In reply to Re: Media Qs about Wellburin aka Zyban, CamW?? and..., posted by Sunnely on February 28, 2001, at 19:32:52

I've been doing a bit of research on bupropion and am interested in your message. Could you tell me your source about hydroxybupropion and CYP2D6. Thanks....


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