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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...


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poster:dj thread:55118
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