US says Teva antidepressant is ineffective

by Matthew Perrone

(AP)—Teva Pharmaceuticals has stopped shipping its generic version of a popular antidepressant off the market after a U.S. government analysis showed the pill does not work properly.

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

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 .

In 2007, the website ConsumerLab published an analysis of the two drugs, indicating Budeprion XL released 34 percent of its in just two hours, compared to 8 percent for the original drug. ConsumerLab is a small privately-held company that independently teswsts 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. Agency officials said they decided to perform their own study after continuing to receive complaints about Budeprion XL 300.

The FDA said it completed its study of the two drugs in 24 adult patients in August, and notified Teva of the findings last month.

"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," said Dr. Gregory Geba, the FDA's director for generic drug.

Wellbutrin, known chemically as buprion, is prescribed to treat depression, anxiety and symptoms of nicotine withdrawal.

The FDA approved the first generic versions of Wellbutrin XL in 2006. Most doctors switch patients from branded drugs to cheaper when they become available, since can cost between 30 to 80 percent less.

Budeprion XL is a once-a-day pill made by U.S.-based Impax Laboratories Inc. and sold by Israel-based Teva Pharmaceutical Industries Ltd.

"FDA's guidance affects the bioequivalence rating of the product and does not reflect any safety issue," said Denise Bradley. "Teva's first priority is to our patients and providing them with quality medicines."

Four other generic drugmakers market 300 milligram versions of Wellbutrin: Anchen, Actavis, Watson and Mylan. The FDA has not tested the equivalence of those drugs, but said it has requested the drugmakers conduct their own studies and submit them to the agency by March 2013.

FDA officials said patients taking the 300 milligram dose of Budepion account for just 2 percent of the U.S. market for the drug.

5 /5 (1 vote)
add to favorites email to friend print save as pdf

Related Stories

Generic versions of plavix approved

May 18, 2012

(HealthDay) -- The first generic versions of Plavix (clopidogrel bisulfate) have been approved by the U.S. Food and Drug Administration.

FDA approves first generic versions of Zyprexa

Oct 24, 2011

(AP) -- Federal health officials on Monday approved the first generic versions of the blockbuster drug Zyprexa, an expensive treatment for schizophrenia and bipolar mood disorder.

First generic lexapro approved

Mar 14, 2012

(HealthDay) -- The Israeli drug maker Teva Pharmaceuticals has gained the first U.S. approval to market generic Lexapro (escitalopram) to treat depression and general anxiety disorder, the U.S. Food and Drug Administration ...

FDA approves generic AIDS drug

Dec 20, 2007

The U.S. Food and Drug Administration has given tentative approval for a generic version of the AIDS drug Viread.

Recommended for you

Study recalculates costs of combination vaccines

Apr 17, 2014

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

Apr 17, 2014

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

User comments