The Food and Drug Administration (FDA) has pulled bupropion, the generic form of the antidepressant drug Wellbutrin, off the market.
The decision was made after analysis showed the generic form of the bupropion, 300 mg dose, was not bioequivalent to its Wellbutrin counterpart. The discovery led to Impax Laboratories and distributor Teva Pharmaceuticals having to stop distribution of the medication due to efficacy and safety concerns.
“The U.S. Food and Drug Administration (FDA) has reviewed new data that indicate Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and marketed by Teva Pharmaceuticals USA, Inc., is not therapeutically equivalent to Wellbutrin XL 300 mg,” said the FDA in a statement.
“This announcement relates only to Budeprion XL 300 mg manufactured by Impax and marketed by Teva. It does not affect the Impax/Teva Budeprion 150 mg product or generic bupropion products made by other manufacturers.”
Bupropion has historically been used as an inexpensive alternative to Wellbutrin, given to patients who have a need for antidepressant medication.
It is currently approved for the treatment of severe depression, and according to the National Alliance on Mental Illness, the medication can also be used for seasonal affective disorder and to aid in smoking cessation. In serious cases, the drug has been used to help women stop smoking during pregnancy.
“This kind of result puts a cloud over all of the generic XL [forms of bupropion],” said to HealthDay News Dr. David Hellerstein, a professor of psychiatry at Columbia University Medical Center, in New York City. “Patient would complain that generic XL is not the same as brand-name XL — it wears off sooner, it has more side effects. I tell patients not to go to XL unless you’re committed to taking brand name.”
According to the FDA, the efficacy of bupropion was not the only issue, and reports of adverse effects had begun to surface within the agency. The agency explained some people taking bupropion complained of fatigue, anxiety, headaches, and worsening depression symptoms; symptoms which improved once patients were switched back to brand name Wellbutrin.
“The role of patients and health care professionals in sharing their experiences with generic versions of Wellbutrin XL 300 mg contributed to further studies, which led to this action,” concluded the FDA. “FDA remains firmly committed to its science-based responsibilities and to making sure that generic drugs are safe and effective.”