Shown: posts 1 to 14 of 14. This is the beginning of the thread.
Posted by Rick on October 12, 2002, at 20:30:11
Thought Babblers might be interested in the following item from Reuters Medical News:
Glaxo Gets OK for Ads Claiming Paxil Not Addictive
LOS ANGELES (Reuters) Oct 11 - A US judge on Thursday told GlaxoSmithKline Plc, Europe's biggest drug maker, that it can claim its anti-depressant Paxil is not addictive.
US District Judge Mariana Pfaelzer rejected a request by attorneys for a group of Paxil users that advertisements stating that Paxil is "non-habit forming" be permanently barred.Last month, Pfaelzer had granted a temporary injunction against the ads, but she delayed the start date of the order until after hearings held this week.
The Paxil users are suing the British-based drug maker in federal court in Los Angeles, claiming that it deliberately played down the severity of withdrawal symptoms associated with abruptly stopping the drug.
A hearing on a bid to certify the case as a class-action lawsuit has been scheduled for Nov. 18, according to Glaxo.
"We are extremely pleased with the ruling," company spokesman Michael Fleming said, adding that Glaxo has not yet decided whether to resume running ads that say Paxil is non-habit forming.
Glaxo last month launched a new ad campaign for Paxil CR, a sustained-release formulation of the drug, that does not include references to whether the drug is habit forming.
The company was supported in court by the US Food and Drug Administration, which said it had previously reviewed in-depth Paxil's side effects and concluded that the drug is not habit forming and, as a result, the ads did not mislead.
The agency also asked that the court reject the plaintiff's argument because the FDA's authority over prescription drug advertising preempts that of the federal courts.
Paxil, Glaxo's top-selling product, reached sales of $2.7 billion last year.
Posted by Alan on October 12, 2002, at 21:55:51
In reply to Glaxo Gets OK for Ads Claiming Paxil Not Addictive, posted by Rick on October 12, 2002, at 20:30:11
I find the entire thing ironic.
Since the main argument is to "disclose all known side effects" they choose to continue to market the drug under false pretense and confusing language.
Think about it. This seems to be the most important issue at the moment: addictive or not. This plays off the stigma we have in society.
"But the FDA labels drugs as habit-forming only when they "cause drug-seeking behavior, often with the user escalating the dose for psychological or physical gratification."
If that is their idea of "habit forming" I wonder what they feel about flat out addiction? While I do see addiction as a form of behavior, to say it is not "habit forming" is twisting words to fit a marketing agenda.
Does anybody else see the irony and stigma placed on this situation? They have been doing it to the benzo class of meds for years.
The trial isn't over yet. And "secrets" like Paxil withdrawal never keep forever.
As long as doctors are pushing an SSRI at every patient who even looks at them cross-eyed, there's not going to be any opportunity to observe drug-seeking behavior. In fact, what they see right now is ssri-AVOIDANT behavior.
But let the doctors start withholding SSRIs and doing all they can to get people off of them (a day that may well come), and then we will see drug-seeking behavior from people who might even prefer to be off but can't possibly quit over the two week period now recommended as a taper.
Hopefully the lawyers for the plaintiffs are clever enough to make that point.
Posted by oracle on October 12, 2002, at 22:42:30
In reply to Re: Glaxo Gets OK for Ads Claiming Paxil Not Addictive, posted by Alan on October 12, 2002, at 21:55:51
The public generally has incorrect ideas about what "habit forming" and "addictive" mean. Neither applies just because one has side effects
because one stops a med.To real issue here should be if ot if not Glaxo
downplayed SE's. Using the word "addictive" is inflamatory.
Posted by Rick on October 13, 2002, at 0:46:38
In reply to Glaxo Gets OK for Ads Claiming Paxil Not Addictive, posted by Rick on October 12, 2002, at 20:30:11
BTW, I agree with the FDA on their assertion that they should retain sole oversight on issues involving drug ad claims. It's maddening and unfortunate that the FDA is unduly influenced by big-company clout, but the courts have no business ruling on what's an acceptable drug ad claim. Going down that road would create a huge legal mess that would benefit no one except lawyers. If an ad claim that's OK in Pittsburgh can be ruled a no-no in Philadelphia, that would kill drug advertising altogether (hmmm...maybe that *wouldn't* be such a bad thing after all...)
Rick
Posted by utopizen on October 13, 2002, at 20:15:47
In reply to Re: Glaxo Gets OK for Ads Claiming Paxil Not Addictive, posted by Rick on October 13, 2002, at 0:46:38
I'm not quite sure how labeling it as habit-forming is going to help those who have developed withdrawl to it already.
Let's admit it to ourselves, many of us were aware these drugs had withdrawl side-effects at the time we were prescribed them. My doctor even gave me Celexa first because he said he wanted to avoid Paxil's withdrawl effects if he could. Obviuosly some claim Celexa has withdrawl effects, but I never had any.
Anyway, people say the same thing about the sexual side effects- doctors will say that the patient doesn't care about hearing them, he just wants to get the prescription and get depression/whatever out of his life. Once it is, that's when they start complaining about sexual side effects.
So I'm not saying people are less legitimate for their argument, but honestly, I knew Effexor has withdrawl problems, and I got on it a few months ago. I'm not going to not take it for a year of better living for fear of two weeks or so of withdrawl. My whole life is sucky, I WISH I could become annoyed that two weeks would be too much.
And what about those patients who complain their doctors didn't tell them about antipsychotic side effects? Good for them. Doctors aren't required to tell me what's on the package insert, and patients are complaining obscure side effects not even common enough to be in the insert should be told to every patient by his doctor?
I was on Accutane, which makes Ritalin backlash and paranoia look benign. It was VERY annoying to hear my doctor go through a long list of side effects. If someone doesn't notice they have neon stools, then that's their problem.
Posted by djmmm on October 14, 2002, at 16:35:28
In reply to Glaxo Gets OK for Ads Claiming Paxil Not Addictive, posted by Rick on October 12, 2002, at 20:30:11
There is a clear distinction between witdraw, associated with an addiction, and discontinuation effects associated with chronic use of a drug.
SSRIs are not addictive, however, abrupt discontinuation after chronic use causes specific effects...theoretically due to the rapid change in the quantity of serotonin at the reuptake pumps, not the drug (ssri) itself. Removing a SSRi allows the pump to function normally, and due to the previously constant presense of serotonin in the synapse, certain receptors have downregulated, causing (over time)less seroton in the synapse. Now that the pumps are functioning normally, the lower concentration of serotonin is taken back up in to pumps causing the "withdraw" we associate with the drug itself.
The same discontinuation syndrome is seen in some MDMA (ecstasy) users days after taking the drug. Serotonin levels are dramatically decreased days after MDMA use
SSRIs change serotonin neurons, this is how (or at least partially) they work. Naturally, there are going to be effects when these meds are stopped.
Posted by Shawn. T. on October 15, 2002, at 16:18:07
In reply to Glaxo Gets OK for Ads Claiming Paxil Not Addictive, posted by Rick on October 12, 2002, at 20:30:11
I really can't express how much of a shame this situation is. I believe that most people on this board would accept that the withdrawal effects of the SSRI+noradrenaline reuptake inhibitor Effexor are more severe than those of the SSRI's. An obvious conclusion is that the effects on noradrenaline cause the problem. Based on this logic, Paxil is more addictive than the other SSRI's. In fact, Paxil is not a selective serotonin reuptake inhibitor according to a recent article in the American Journal of Psychiatry. In vivo, Paxil inhibits noradrenaline reuptake by approximately 27%. So the next time you hear that the "selective" serotonin reuptake inhibitor Paxil isn't addictive, you should thank the FDA for allowing such lies to be spread.
http://ajp.psychiatryonline.org/cgi/content/abstract/159/10/1702
Shawn
Posted by FredPotter on October 15, 2002, at 22:30:20
In reply to American Journal of Psychiatry: Paxil not an SSRI, posted by Shawn. T. on October 15, 2002, at 16:18:07
When doctors worry about addiction in benzos etc aren't they really worried about people taking pills to get a pleasant buzz instead of taking them because they're ill? That doesn't happen with SSRIs but it does with benzos apparently, although I can't see what the fuss is about
Posted by Rick on October 15, 2002, at 23:12:01
In reply to American Journal of Psychiatry: Paxil not an SSRI, posted by Shawn. T. on October 15, 2002, at 16:18:07
Very interesting! I understand that none of the SSRI's are really completely "selective" (although the Lexa's are close), but it's surprising to see how much of an adrenergic impact Paxil has.
But re the conclusion that noradrenaline reuptake inhibition underlies the withdrawal difficulties... aren't there other NRI's (some TCA's, reboxetine) that *aren't* known for withdrawal distress?
Rick
> I really can't express how much of a shame this situation is. I believe that most people on this board would accept that the withdrawal effects of the SSRI+noradrenaline reuptake inhibitor Effexor are more severe than those of the SSRI's. An obvious conclusion is that the effects on noradrenaline cause the problem. Based on this logic, Paxil is more addictive than the other SSRI's. In fact, Paxil is not a selective serotonin reuptake inhibitor according to a recent article in the American Journal of Psychiatry. In vivo, Paxil inhibits noradrenaline reuptake by approximately 27%. So the next time you hear that the "selective" serotonin reuptake inhibitor Paxil isn't addictive, you should thank the FDA for allowing such lies to be spread.
>
> http://ajp.psychiatryonline.org/cgi/content/abstract/159/10/1702
>
> Shawn
Posted by Rick on October 15, 2002, at 23:30:26
In reply to Re: American Journal of Psychiatry: Paxil not an SSRI, posted by FredPotter on October 15, 2002, at 22:30:20
When you say "it does with benzos apparently," what does the "it" refer to? Doctors worrying, or benzos creating a pleasant buzz? I'm guessing the former, but I'm not sure. Either way, I agree that it's hard to see the justification for the amount of hand-wringing that takes place over benzos.
I know I haven't had a "pleasant buzz" from Klonopin since the third day of the three years I've been taking it. OTOH, that one .5 mg Xanax I may take once every 3-4 months for rare insomnia may create a very mild buzz/acute relaxation...but certainly nothing that makes me want to keep popping more.
Rick
> When doctors worry about addiction in benzos etc aren't they really worried about people taking pills to get a pleasant buzz instead of taking them because they're ill? That doesn't happen with SSRIs but it does with benzos apparently, although I can't see what the fuss is about
Posted by chad_3 on October 15, 2002, at 23:40:47
In reply to American Journal of Psychiatry: Paxil not an SSRI, posted by Shawn. T. on October 15, 2002, at 16:18:07
Now I get it!
Well I'm kidding (halfway) - but I did notice two things (not counting sedation / apathy / sleepiness) - with Paxil that resembled Effexor to me. One was a deeper voice - the other was a this effect where my "manhood" did not express itself so fully.
The other antidpepressant which I noticed *really* put the skinny on my manhood was "reboxetine" - the pure NA drug - apparently a common side effect.
Hmm.
I will continue to stay with the MAOI's and Klonopin for now....
PS
So what is deal with Lexapro - have not read about it - is this drug like Serzone or like Celexa.
PPS the new prozac is more prozac per capsule.Chad/Kregpark/ActionJackson/Rick1001/Ray etal etal
> I really can't express how much of a shame this situation is. I believe that most people on this board would accept that the withdrawal effects of the SSRI+noradrenaline reuptake inhibitor Effexor are more severe than those of the SSRI's. An obvious conclusion is that the effects on noradrenaline cause the problem. Based on this logic, Paxil is more addictive than the other SSRI's. In fact, Paxil is not a selective serotonin reuptake inhibitor according to a recent article in the American Journal of Psychiatry. In vivo, Paxil inhibits noradrenaline reuptake by approximately 27%. So the next time you hear that the "selective" serotonin reuptake inhibitor Paxil isn't addictive, you should thank the FDA for allowing such lies to be spread.
>
> http://ajp.psychiatryonline.org/cgi/content/abstract/159/10/1702
>
> Shawn
Posted by djmmm on October 16, 2002, at 14:47:07
In reply to American Journal of Psychiatry: Paxil not an SSRI, posted by Shawn. T. on October 15, 2002, at 16:18:07
That's not really news, in fact "SSRI" is somewhat of a misnomer. All SSRIs effect other neurotransmitter systems; ironically, Prozac, the prototype SSRI, is not very selective at all.
I believe when this term was coined, med developers were attempting to distinguish between medications with a tricyclic structure, primarily effecting norepinephrine, and these "new" meds unrelated in structure, primarily effecting serotonin.
Calling Prozac, Paxil or Zoloft "SSRIs" is like calling a TCA a "SNRI"..... it's semantics, and the terms are used simply for classification
Posted by Shawn. T. on October 16, 2002, at 16:31:48
In reply to Re: American Journal of Psychiatry: Paxil not an SSRI, posted by djmmm on October 16, 2002, at 14:47:07
I think that the big difference between Paxil and SNRI's is that Paxil combines a moderate SNRI component with the most potent serotonin reuptake capability available. The strong potency is likely a big part of the withdrawal issue, but my thinking is that the addition of the noradrenaline reuptake component makes Paxil truly unique. As far as the semantics issue is concerned, I believe that it is important for health care consumers and doctors to be aware of the differences that exist among a class of seemingly similar medications. Having this knowledge available makes it easier to avoid complications that a patient might be concerned about. Someone that has had serious problems with Effexor might not want to make Paxil his or her next choice of treatment.
With regards to tricyclic antidepressants and a relative lack of withdrawal symptoms, this could be a result of a longer half-life of either the parent compound or an active metabolite. I'm not a TCA expert, so I can't really say for sure.
Really the big issue with regards to all of this is what constitutes acceptable advertising for psychoactive drugs. Deciding to take an SSRI or a related drug is a serious choice. Misleading advertising should not be allowed to convince a person to make such an important decision that they might not otherwise make. If a company were to advertise that a benzodiazepine with a short half-life is nonaddictive, I don't believe that many health experts would find that acceptable.
Shawn
Posted by Rick on October 16, 2002, at 17:37:02
In reply to Re: American Journal of Psychiatry: Paxil not an SSRI, posted by Shawn. T. on October 16, 2002, at 16:31:48
>If a company were to advertise that a benzodiazepine with a short half-life is nonaddictive, I don't believe that many health experts would find that acceptable.
That's for sure. On a related note, I find it interesting that a med like Provigil, which you can stop on a dime, is in a restricted-substance class, while Effexor and Paxil aren't. I guess it's because there was an experiment where some monkeys chose to go for more Provigil after they had been given some. Given how much monkeys like sex, I guess the drugmakers aren't too worried that they're going to trade in their bananas for more Paxil or Effexor. What's really going on here in the benzos vs AD department -- at least where non-depressive anxiety disorders are concerned -- boils down largely to three things:
1) Money Talks. SSRI's shout, "$$$$$!!," while
off-patent benzos cower and whisper, "cents?"
2) Doctors want to impress their peers, and benzos
are just too unglamorous and seem like the
"easy way out"
3) Doctors are afraid of malpractice suitsRick
This is the end of the thread.
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