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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 11 of 11. This is the beginning of the thread.
Posted by jrbecker on March 16, 2003, at 18:50:33
Serzone Under Fire (March 15, 2003)
Public Citizen, the public interest lobby founded by Ralph Nader, has petitioned the FDA to immediately remove Serzone from the US market. The petition cites “28 reports of liver failure leading to necrosis or death,” involving 18 deaths worldwide. According to Public Citizen, in January this year the drug’s manufacturer, Bristol-Myers Squibb. withdrew Serzone from Sweden when regulators there demanded a liver enzyme monitoring requirement be added to the product's labeling, and very soon after from the rest of Europe when other countries were considering the same requirement. Public Citizen also pointed out that Serzone is metabolized by the enzyme CYP3A4, which results in raised toxicity for other drugs administered simultaneously, including a 50-fold increase for Buspar. Other drugs affected include Xanax, Halcion, desipramine, Tegretol, Prozac, and the MAOIs.
The drug's labeling contains a black box warning added in Jan 2002, stating that one side effect is potential fatal liver failure. Bristol-Myers says it pulled out of Europe because of low sales rather than safety issues.
http://www.mcmanweb.com/news.htm
Posted by SLS on March 16, 2003, at 19:46:04
In reply to News - Serzone Under Fire , posted by jrbecker on March 16, 2003, at 18:50:33
Hi.
Serzone has already been withdrawn voluntarily from the entire European market.
It is easy to shake a finger at a drug for the liabilities it has. Very few drugs are without side effects or risks. I'm not advocating the continuance of the sale of nefazodone, but I wonder how many of these activists suffer from a life-altering depression for which it is the only effective treatment. What about the people for whom it is the only effective antidepressant that does not inflict ruiness sexual side effects? Is this sufficient reason to keep it available?
It is easy to bash a drug without perspective. How does 18 Serzone deaths worldwide compare to the thousands of cases of irreversible tardive dyskinesia caused by neuroleptic antipsychotics? How many cases of hepatic failure occur in a similar sized cross section of the general population? How many people have died from the cardiac complications of tricyclics? How do the deaths from pneumonia as the iatrogenic consequence of cancer chemotherapy compare in acceptability? Is it acceptable to have in the pharmacopeia an antidepressant that produces EPS at rates comparable to antipsychotics (amoxapine)? Was the rate of hemolytic anemia high enough for nomifensine to warrant its withdrawal from the sizeable number of people for whom it was the only antidepressant to ever work?
Maybe we can simply monitor liver enzymes on a regular basis as is now necessary for Tegretol and Depakote. I'm pretty sure that agranulocytosis occurs with Tegretol at a rate far greater than that seen with Serzone hepatotoxicity.
Should nefazodone be withdrawn? Personally, I don't have enough information to have developed what I deem to be an appropriate perspective. I wonder if the Nader people have.
- Scott
Posted by stjames on March 17, 2003, at 16:17:29
In reply to Re: News - Serzone Under Fire , posted by SLS on March 16, 2003, at 19:46:04
Maybe we can simply monitor liver enzymes on a regular basis as is now necessary for Tegretol and Depakote. I'm pretty sure that agranulocytosis occurs with Tegretol at a rate far greater than that seen with Serzone hepatotoxicity.
I take Lopid, which requires liver enzymes
to be checked and it has not been a big deal
to do this.
Posted by Tabitha on March 18, 2003, at 0:38:56
In reply to News - Serzone Under Fire , posted by jrbecker on March 16, 2003, at 18:50:33
Too bad. If you google serzone nowadays all you see are lawfirms looking to sue on your behalf. It will probably be driven off the market.
If Ralph Nader drives it off, does that make it the Corvair of ADs? Who remembers 'Unsafe at Any Speed'.
I'll be bummed, since except for Serzone, all the ADs give me my choice of insomnia+sexual dysfunction, or sedation+weight gain.
Posted by utopizen on March 18, 2003, at 4:21:17
In reply to Re: News - Serzone Under Fire , posted by Tabitha on March 18, 2003, at 0:38:56
I don't understand why Public Citizen hasn't gone after Gabitril, or even mentioned it, to my knowledge. That made my psychotic for a night!!! I'm not a psychotic, I was taking it for social anxiety!! I thought I was going to die or be institutionalized!
Posted by stjames on March 18, 2003, at 11:43:00
In reply to Re: News - Serzone Under Fire , posted by utopizen on March 18, 2003, at 4:21:17
> I don't understand why Public Citizen hasn't gone after Gabitril, or even mentioned it, to my knowledge. That made my psychotic for a night!!! I'm not a psychotic, I was taking it for social anxiety!! I thought I was going to die or be institutionalized!
So a med should be taken off the market just because you had a problem ? What about all those
who were helped ?
Posted by KrissyP on March 18, 2003, at 12:34:02
In reply to News - Serzone Under Fire , posted by jrbecker on March 16, 2003, at 18:50:33
Posted by KrissyP on March 18, 2003, at 12:35:33
In reply to Re: News - Serzone Under Fire , posted by Tabitha on March 18, 2003, at 0:38:56
Posted by KrissyP on March 18, 2003, at 12:36:26
In reply to Re: News - Serzone Under Fire , posted by stjames on March 18, 2003, at 11:43:00
Posted by utopizen on March 18, 2003, at 17:35:36
In reply to Re: News - Serzone Under Fire , posted by stjames on March 18, 2003, at 11:43:00
5{ understand why Public Citizen hasn't gone after Gabitril, or even mentioned it, to my knowledge. That made my psychotic for a night!!! I'm not a psychotic, I was taking it for social anxiety!! I thought I was going to die or be institutionalized!
>
> So a med should be taken off the market just because you had a problem ? What about all those
> who were helped ?
>Um, I never said that.
We can learn a lot about anxiety, possibly, if we investigate why people like me go psychotic on it.
Just because a bad reaction occurs from a med, that's not to say you either have the option to keep it on the market or take it off. There's this thing called "research" that is an option in-between.
Posted by stjames on March 18, 2003, at 17:41:03
In reply to Re: News - Serzone Under Fire » stjames, posted by utopizen on March 18, 2003, at 17:35:36
> Um, I never said that.
NO, but you choose "Public Citizen" which is like
using a sledge hammer to deal with something that should and is normally reported to the FDA.
This is the end of the thread.
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