October 2012
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FDA Tells Teva To Pull Generic Wellbutrin, Says It Doesn’t Work Properly

If you take a generic version of anti-depressant Wellbutrin, it’s time to take a look at your medicine bottle because it may be being pulled. The Food and Drug Administration has asked Teva Pharmaceuticals to pull its generic version of Wellbutrin before new tests indicate that it is not working properly:

The Food and Drug Administration said Wednesday it asked Teva to withdraw Budeprion XL 300 after new testing showed the drug releases its key ingredient faster than the original drug Wellbutrin XL 300, made by GlaxoSmithKline.

A spokeswoman for Teva said the company stopped shipping the drug last Thursday.

The action contradicts the FDA’s previous update on the issue in 2008, when regulators said the drugs are essentially the same. That review came after hundreds of patients complained that Teva’s drug did not work as well or caused side effects like headaches, anxiety and insomnia.

In 2007, the website ConsumerLab published an analysis of the two drugs, indicating Budeprion XL released 34 percent of its active ingredient in just two hours, compared to 8 percent for the original drug. ConsumerLab is a small privately-held company that independently tests drugs and nutrition products.

FDA tells Teva to withdraw its generic antidepressant, saying it does not work properly

If you are concerned about the generic drugs that you take, here are some things to keep in mind:

Generic Drugs are “Bioequivalents.” The FDA considers generic drugs to be “identical, or bioequivalent, to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.” However, generic drugs may have a different color, shape or taste than the original brand-name drug.

Generic Drugs Are Reviewed by the FDA. To assure quality, safety and effectiveness, the FDA puts all generic drugs through a thorough review process, including a review of scientific information about ingredients and performance. In addition, the FDA requires that generic drug manufacturers meet the same manufacturing plan standards as those of brand name drugs.

If You Have Any Reaction to Your Generic Drugs…. Despite the FDA’s finding of bioequivalency, some patients have reported reactions to their new medication when switching from brand name to generic or vice versa. These may be due to differences in the inactive ingredients or variations in the amount of active ingredient or the release of the active ingredient in the new drug. As with any new medication, if you have any side effects or have any concerns about changes that have occurred since switching your drugs, you should contact your doctor immediately.

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  5. A Note About Generic Drug Safety

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