Bad Medicine: Teva’s Budeprion XL antidepressant pulled from the shelves
Budeprion XL was supposed to be a generic version of Wellbutrin, made by GlaxoSmithKline. It was manufactured by Impax Laboratories for Teva Pharmaceutical Industries Ltd., the largest generic-drug maker in the world…and it was approved in 2006. So what happened?
How this came about
After 85 people complained in 2007 about headaches, anxiety, and sleeplessness, or about the drug simply not working as well as the brand version, the FDA reviewed the product in 2008 and found the drug acceptable. It stayed on the shelves. But an independent company, ConsumerLab was also on the case. In 2007, prompted by alert pharmacists, they did a side-by-side comparison of the Wellbutrin and Budeprion XL and concluded that the generic version released its active ingredient much faster than the branded drug –almost four times as fast. ConsumerLab found that in a two hour window, Wellbutrin drops 8% of its time-release payload. In the same time period, Budeprion XL releases 34%.
Five years goes by. Finally, the FDA takes another look.
What went wrong
A series of things are in play that should alarm everyone in the pharmacy industry. The crux of the matter is simple. The FDA only examined findings from 150 mg doses of the generic drug, but then it was sold in 300 mg doses. The leap in logic, that if 150 mg is safe and effective, then double that must be safe and effective as well, is erroneous. What’s interesting is how this got past the manufacturer AND the FDA. The law says that generic drugs have to be chemically equivalent to the original drug, and work exactly the same way. Clearly, things slip through the cracks.
Questions and more questions
Why was testing so lax? Even a cook will tell you that doubling the recipe can produce some unexpected results, so why would the FDA – or the manufacturer- not test the drug at every dosage? And why, after an independent lab tested it, did it take five full years for the FDA to respond, even in the face of consumer complaints?
Naturally, this has led to a lawsuit, and U.S. District Judge Berle Schiller recently ruled that FDA approval does not absolve generic drug manufacturers from product responsibility. The suit is moving forward, and the language is clear, that both Impax and Teva knew the generic drug released its active ingredient faster and marketed it anyway with no warning. If this lawsuit is won, more will inevitably follow.
This could have a ripple effect in the pharma industry. Testing requirements could become more rigorous, and probably should. This isn’t the first issue arising from generics that don’t work exactly the same as brands. Wellbutrin is likely to regain its market share, with the competition knocked out of the ring, but what about other drugs? It will be interesting to see whether or not the brand manufacturers seize an opportunity to push for testing of other competing generics. Certainly the highest prescribed strength of any medication should be thoroughly vetted before release.