FDA: Antidepressant is ineffective
Posted: Wednesday, October 17, 2012 8:00 pm
WASHINGTON (AP) — Teva Pharmaceuticals has stopped shipping its generic version of a popular antidepressant after a federal analysis showed the pill does not work 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.
“We’re proud we were able to help uncover this problem, but it’s unfortunate that it’s taken the FDA five years to get the product removed,” said Dr. Tod Cooperman, president of ConsumerLab.
“I believe the majority of generics are fine, but there are certainly situations where some aren’t equivalent.”
Generic drugs approved by the FDA are required to be chemically equivalent to the original products, producing the same medical effects in patients.
The FDA said Wednesday that its initial, incorrect ruling was based on tests of the 150 milligram version of Budeprion, under the assumption those results would also apply to the 300 milligram version.
The agency said that approach “is no longer appropriate.”
“Based on the information we had available at that time we concluded that the 150 milligram strength was doing what it should, and that it was acceptable to extrapolate those findings to the 300 milligram strength” said Barbara Davit, director of bioequivalence for FDA’s office of generic drugs. Published in The Messenger 10.17.12