FDA Approves Useless Generic Antidepressant

[Jemima]

This event is revolting all by itself, plus I wonder how many psychiatric patients got doped up with even more drugs when this one failed to act as expected.

 

"Last week, the FDA took a drug off the market, and the reasons should send shivers of fear down the backs of consumers, investors, generic drug companies – and the FDA.

 

The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it."

 

http://www.forbes.com/sites/davidmaris/2012/10/10/fda-recall-points-to-serious-problems-at-the-fda/

[compsports]

This event is revolting all by itself, plus I wonder how many psychiatric patients got doped up with even more drugs when this one failed to act as expected.

 

"Last week, the FDA took a drug off the market, and the reasons should send shivers of fear down the backs of consumers, investors, generic drug companies – and the FDA.

 

The FDA announced last week that the 300mg generic version of Wellbutrin XL manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals was being recalled because it did not work. And this wasn’t just a problem with one batch – this is a problem that has been going on with this particular drug for four or five years, and the FDA did everything it could to ignore it."

 

http://www.forbes.com/sites/davidmaris/2012/10/10/fda-recall-points-to-serious-problems-at-the-fda/

 

It is disgusting as people have been complaining for years about this drug. But I guess the FDA just like psychiatry in general had the attitude that "mental patients" are not to be trusted. For shame.

 

CS

[Barbarannamated]

Very important info regarding the generic approval process, though this case with Wellbutrin brought it to light.

 

I was in communication with the Graedons of The Peoples' Pharmacy early on with this. Husband switched to generic when it became available and went downhill rapidly. *Fortunately*, it was a linear type regression/relapse: fatigue, lowered mood, and not bizarre withdrawal effects as with SS/NRIs. I only say "fortunately" because it was fairly easy to pinpoint cause and effect. Also, Peoples' Pharmacy had many other reports of trouble with the 300mg generic. My understanding is that the 150mg is ok but the 300mg bioequivalence was never tested and the extended release coating was breaking down too fast, resulting in higher peak drug levels sooner and then dropping off sooner. I hadn't thought about the impact on seizure threshold until reading this article.

 

I've posted several times about my problems with generics. I realize insurance mandates use of generics in most cases and brand drugs are prohibitively expensive. IMHO, it's prudent to know which generic is dispensed and which ones work for each of us. Drug/pill Identifier sites help.

 

In the past, some generics were manufactured by the same company that manufactured the brand, but I'm not certain if that is still the case. I believe the brand manufacturer had first dibs on generic for a protected period of time.

 

Thanks for this article, Jemima. I'm not in the process of tapering, but considering the precision of the cuts, this info and the +/- 20% bioequivalence rule is good to be cognizant of.

 

Interesting comment by psychiatrist Moskovitz who sounds reasonable and vigilant:

 

"Wellbutrin XL was designed to release the drug more slowly than its predecessor Wellbutrin SR. This was done primarily to lower the peak blood level at any given dose. Since the risk of seizures with Wellbutrin was related primarily to peak levels, the slower absorption allowed patients to take 300 mg as a single daily dose. Lack of bioequivalence of generics, therefore, introduced the additional possibility of too rapid absorption and risk of seizures. As a psychiatrist, I observed relapses in patients switched to generics soon after they were introduced. I learned that Wellbutrin XL accomplished its goal by embedding the drug within an inert matrix, while conventional tablets dissolved entirely in the GI tract. With the help of a pharmacist, I identified one generic that appeared to use the same technology and which proved over time to be a reliable substitute. Others that I examined were constructed in the conventional way. From then on I always specified either Wellbutrin XL by brand or the specific generic that I believed to be equivalent."