Generic Anti-Depressant Drug Faces Voluntary Recalls

by sequoialegal on December 4, 2012

The American public relies on the Food and Drug Administration to keep the pharmaceutical market safe and effective.  If a drug has been approved, almost no one would find a need to question it and would readily accept a prescription from their doctor.  Unfortunately, the FDA has apparently become a bit lackadaisical in their approval methods, hence the recently issued voluntary recall of the generic Wellbutrin XL 300.

Wellbutrin XL 300 is a popular medication used for treating depression and seasonal affective disorder.  Five years ago, a generic equivalent called Budeprion XL 300 was introduced to the market and many patients switched over to the more cost effective option.  The People’s Pharmacy, a consumer advocacy group, soon began hearing complaints from those who had switched to Budeprion.  People were complaining of anxiety, depression, headaches and trouble sleeping.  Patients who had never had any trouble on Wellbutrin were suddenly experiencing suicidal thoughts. 

Although the People’s Pharmacy voiced their concerns and even had Consumer Lab, an independent testing company in New York, test the generic brand against Wellbutrin with findings of a definite difference, the FDA held firm in their approval of Budeprion XL 300.  They did ask Teva to perform some tests on volunteers, should they find the time.  Teva claimed they had difficulty finding test subjects and the matter never went any further.

In 2010, the FDA finally took some action and did a trail on 24 independent subjects taking Budeprion XL 300 manufactured by Teva Pharmacueticals.  Just as Consumer Lab had discovered, it showed that although the active ingredient in Wellbutrin and Budeprion were exactly the same, the release rate differed greatly.  Budeprion released 34% of its drug within the first two hours, while Wellbutrin had a steady release of only 8% by the same time period.  After 4 hours, Budeprion had released half of it’s product, and Wellbutrin had only released one fourth.  The generic brand was proving to respond more like an immediate release medication instead of the one a day formula it was supposed to be.  It was discovered that the original pill had a membrane that allowed the drugs to slowly come out over an extended period.  The newer generic brand from Teva just breaks apart.  The study also showed that the Budeprion from Teva only delivered 75% of the drug.

This practice of passing higher dosage drugs based on lower-dose version is called “waiving up,” and the FDA is still standing behind the practice.  They claim that it works with a majority of drugs on the market.  This recall brings up a lot of questions about the safety of other generic versions of drugs, specifically of Wellbutrin.  And if the FDA turned a blind eye on the issues with one drug, then who’s to say there aren’t others out there on the market that aren’t doing their job or might have averse side effects?  The FDA has asked other generic drug companies to test their products and produce results by March of 2013.

Article Written By Legal Blogger Juanita Williams, on behalf  of personal injury attorney Michael Brennan




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