Generic Wellbutrin To Get FDA-Sponsored Human Trial Over Safety Concerns

The Wall Street Journal is reporting that generic Wellbutrin XL is going to be the subject of a human trial sponsored by the FDA in hopes of getting at the cause of patient reports that the generic version of the anti-depressant either doesn't work or has awful side effects. The move comes five months after the FDA responded to earlier reports that the generic drug, distributed by Teva, was causing all manner of problems by declaring the drug safe.

Suspicions centered on Teva using a different time-release coating than the patented version of the drug employed, resulting in too much of the drug being delivered at once. The new drug ended up causing all sorts of problems for people whose insurance companies forced them to switch to the generic version of the drug.

Once the FDA declared the generic version safe, patient reports started pouring into the authors of the excellent People's Pharmacy, which is both a syndicated column and website.

From Pharmalot:

"Joe Graedon, a pharmacologist and co-founder of the People’s Pharmacy, wasn’t satisfied with the FDA review and tells the paper complaints about the generic are still being logged on his Web site. He argues the agency probe was unsatisfactory because it was based on data from the 150-milligram version of the drug, not the 300-milligram dose that is at the center of the complaints.

"This past summer, Graedon and others were granted a meeting with senior officials from the FDA’s Center for Drug Evaluation and Research, and he tells the paper there was a 'consensus' by the end of the meeting that the two sides could collaborate on a study that would involve patients who reported problems with the generic after taking the branded version. But he can’t begin a recruitment effort until he is given the details of the study design, and is still waiting to hear from the FDA.

"The FDA spokeswoman says the agency still supports conclusions released in April. While it believes that critics 'are attributing the wrong cause for the problem,' the agency also believes the complaints are “sincere” and is therefore prepared to do more work on the matter. 'The FDA agrees it is important to study further if there is some specific reason…for the product to be not effective in these patients,' she tells the paper."

I'll give the FDA credit for being willing to study the issue, but standing by its earlier claims of safety looks a bit silly to me at this point.