National Alliance on Mental Illness
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I just heard on the news that the FDA is recalling a generic version of Wellbutrin XL (bupropion XL). Can you explain this? Should I stop taking my medication?
By: Karen E. Moeller, PharmD, BCPP
The Food and Drug Administration (FDA) announced in early October that the generic medication Budeprion XL 300 mg, which has the same active ingredient, bupropion hydrochloride, as Wellbutrin XL, manufactured by Impax Laboratories, Inc. and marketed by Teva Pharmeuticals USA, Inc. was not equivalent to the brand name drug Wellbutrin XL 300 mg. The FDA has asked Impax/Teva to recall or remove Budeprion XL 300 mg from the market. Wellbutrin XL is approved for treatment of major depressive disorder and seasonal affective disorder. Results from a recent study of people taking Budeprion XL 300 mg conducted by the FDA found that only 75 percent of the medication entered the bloodstream. Thus people who were switched from brand name Wellbutrin XL to Budeprion XL may see return of symptoms of depression or lack of effectiveness from the drug. However, this was NOT found with the 150 mg strength of Budeprion XL and the FDA has stated that the 150 mg strength of Budeprion XL is bioequivalent to Wellbutrin XL 150 mg.
It is also important to note that there are currently four other generic manufacturers that produce generic versions of Wellbutrin XL 300 mg. These generic products have NOT been recalled by the FDA. Additionally, the FDA believes the results from their study only apply to the Impax/Teva generic product based on consumer complaints. However, the FDA has asked the other generic manufacturers to study the bioequivalence of their 300 mg product to Wellbutrin XL 300 mg.
Consumers may wonder why the FDA approved this generic formulation if it was not bioequivalent. The FDA does require generic manufacturers to demonstrate that their medication is bioequivalent to the brand name product. In the case of Wellbutrin XL generic manufacturers compared their 150 mg product to the brand name Wellbutrin XL 150 mg. Results from these studies found the 150 mg strengths comparable. However, studies were not conducted on the 300 mg strengths of their product. Results from the bioequivalence studies of the 150 mg strength were used to approve the 300 mg product. Thus no direct comparisons were made between the 300 mg strengths.
One may also be worried about taking generic medications after reading this report. Overall there are over 10,000 FDA approved generic medications and complaints about generic drugs are rare. It is important when a prescription is picked up to check and see if there has been a switch to a generic medication or if there has been a switch to a different generic made from another generic manufacturer. If new side effects or worsening symptoms occur while taking these new products, contact a health care professional and ask them to report it to the FDA.
U.S. Food and Drug Administration (2012, Oct 3). Questions and Answers Regarding Market Withdrawal of Budeprion XL 300 mg Manufactured by Impax and Marketed by Teva. Retrieved from http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm322160.htm#q2
U.S. Food and Drug Administration (2012, Oct 3). FDA Update: Budeprion XL 300 mg Not Therapeutically Equivalent to Wellbutrin XL 300 mg. Retrieved from http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm322161.htm