Generic Wellbutrin XL Recalled, Not As Effective As Original: FDA

Federal health officials have issued a recall for a generic equivalent of Wellbutrin XL, marketed by Teva Pharmaceuticals as Budeprion XL 300 mg, due to a recent study that established the antidepressant is not equivalent to the name-brand version, is not effective and may actually worsen depression in some consumers.

The FDA announced a Budeprion XL recall on October 5, revoking authorization for the 300mg dosage of generic Wellbutrin. The action came after a recent study involving 24 individuals found that the drug is not properly released into the bloodstream.

The generic brand does not release the budeprion into the blood stream at the same rate or amount as Wellbutrin XL 300mg, which can cause adverse consequences to consumers that switch from Wellbutrin XL 300 mg to Budeprion XL 300 mg.

The FDA indicates that this finding could explain why depression has increased in patient’s that switched medications.

Wellbutrin (bupropion) is a popular antidepressant manufactured by GlaxoSmithKline, which was first approved by the FDA in December 1985. The drug was recalled from the market the following year due to a high number of seizures associated with Wellbutrin side effects, but it was reintroduced in 1989 after federal reviewes determined that the seizures were dose specific and lowered the daily dosage of the drug.

More recently, concerns have emerged about a potential risk of birth defects from Wellbutrin when used during pregnancy, after studies found that women who used the antidepressant during the first trimester had double the chance of giving birth to a child with a congential heart problem, known as a left outflow tract defect.

Wellbutrin XL 300mg is a high-dose version of the tablet, designed to provided extended antidepression relief.

Budeprion XL 300 mg was manufactured by Impax Laboratories, Inc. and marketed by Teva Pharmaceuticals, Inc.

Actavis, Anchen, Mylan, and Watson, who are four other generic drug makers that make 300 mg bupropin tablets, have been asked by the FDA to conduct similar studies to verify the therapeutic equivalence of their generic Wellbutrin versions by March 2013.

Consumers who are taking a generic brand of antidepressant should check with their doctor about changing the medication to Wellbutrin XL, since the other four generic brands equivalence has not been proven yet.