FDAnews Drug Daily Bulletin

Data from tests of generic versions of GlaxoSmithKline’s (GSK) Wellbutrin might explain why consumers have had complaints about these products, according to a report from ConsumerLab.com.

ConsumerLab.com evaluates health and nutrition products, including vitamins and supplements. The company said it initiated its study of GSK’s antidepressant Wellbutrin (bupropion HCl) after being contacted by the authors of “The People’s Pharmacy,” a syndicated newspaper column. The column had received reader reports of problems with generic versions of once-a-day Wellbutrin XL.

Personal accounts posted at www.peoplespharmacy.com indicate that after switching from brand Wellbutrin to generic, many people had symptoms such as headaches, irritability, nausea and insomnia. Others experienced a return of depressive symptoms. Switching to the branded product brought symptoms under control for many people.

The ConsumerLab.com tests show that the generic product released the active ingredient at a different rate than brand Wellbutrin XL. They also show that two generic Wellbutrin SR products released the drug at different rates. Time-released generic drugs often use tablet technologies different from the original product.

The Generic Pharmaceutical Association (GPhA) scoffed at the report, urging consumers to side with the FDA and the U.S. Pharmacopeia over a company “that contracts out testing for headlines.”

The full report is available to ConsumerLab.com subscribers at www.consumerlab.com/results/wellbutrin-bupropion.asp.