Generic Wellbutrin Comes Under FDA Microscope

[David Baxter PhD]

Generic Wellbutrin Comes Under FDA Microscope
FDAnews Drug Daily Bulletin
Sept. 25, 2008 | Vol. 5 No. 188

The FDA is considering a postmarketing study of Teva Pharmaceutical Industries? generic version of the antidepressant Wellbutrin XL in patients who have reported problems with it, agency spokeswoman Crystal Rice said.

In April, consumer advocates said they were skeptical of the FDA?s clearance of the drug, noting that the agency had received 85 postmarketing reports of patients experiencing side effects, such as loss of antidepressant effect, after switching from GlaxoSmithKline?s (GSK) brand version of the drug to the generic version between Jan. 1 and June 30, 2007.

 

[suewatters1]

Interesting story thanks for posting it

Sue

 

[Retired]

According to the Health Canada Product Database, Teva Pharmaceuticals does not market bupropion in Canada, the company whose product is being investigated by FDA.

If you have concerns about the efficacy or tolerbility of the medication which has been prescribed for you, and you wish to switch to an different manufacturer's version of the compound (if applicable), then, depending on the laws of the jurisdiction in which you live you can ask your pharmacist or doctor to change the prescription.

In some jurisdictions, pharmacists can, on their own, change from one manufacturer to another, while in others, the physician must approve the change. In other places, all that's needed is the patient's request to the pharmacist.