US FDA says generic Wellbutrin OK despite reports

	Tweet

A cheaper, generic version of GlaxoSmithKline Plc’s Wellbutrin XL antidepressant is just as safe and effective, despite complaints from some patients, the U.S. Food and Drug Administration said on Wednesday.

The FDA said it received 85 reports from patients who switched from Wellbutrin XL to a cheaper generic made by Teva Pharmaceutical Industries Ltd, including 78 who said they slipped back into depression.

Other patients reported new or worsening side effects, including headaches, fatigue, anxiety and digestion issues.

"The question is whether the reported lack of efficacy and/or new onset side effects in these patients who switched suggest a problem with the generic product ... or have some other explanation,” the FDA said in a statement on its website.

Agency scientists reviewed the two drugs, which both use formulations of a chemical called bupropion, and found the data did not show that the problems stemmed from any differences between the two drugs.

One factor that could account for the reported problems is the natural recurrence of depression, which can happen despite treatment, the FDA said.

Half of the patients who went back on the name-brand drug improved, the agency said, adding that it would continue to monitor the issue.

By Susan Heavey
WASHINGTON (Reuters)

RELATED STORIES:
Is ADHD tied to adulthood obesity?   Merck tried to bury Vioxx concerns for years   Asia nations agree to stockpile anti-bird flu drugs   Novartis drug aids bones in Paget’s disease   Putting an old drug to a new use   Bristol-Myers Squibb and Otsuka Pharmaceutical announce availability of 2 mg Abilify (aripiprazole)   People affected by autism believe increase is ‘real,’ not diagnostic   Study: Plavix saves lives after big heart attacks   AstraZeneca drug risk higher than others   Short antibiotic course effective in COPD flare-ups   Be happy and you’ll be more successful   Public to view drug side effects

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]