US says Teva antidepressant is ineffective

October 3, 2012 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.

Explore further: Generic versions of plavix approved

shares

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.

First generic versions of singulair approved

August 4, 2012
(HealthDay) -- The first generic versions of Singulair (montelukast sodium) have been approved by the U.S. Food and Drug Administration.

FDA approves first generic versions of Zyprexa

October 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

March 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 warns of fake version of ADHD drug Adderall

May 30, 2012
(HealthDay) -- A counterfeit version of the attention-deficit/hyperactivity disorder drug Adderall, sold online, contains the wrong active ingredients, according to the U.S. Food and Drug Administration.

Recommended for you

Opioids overused in migraine treatment, regardless of race, study finds

August 17, 2017
African-Americans are more likely to experience debilitating migraine headaches than whites, but a new study probing the issue found no evidence of racial disparities in treatment practices.

Finding better ways to reduce serious drug side effects

August 14, 2017
Many of the medicines we depend on to treat disease—and even to save our lives—pose potentially serious risks along with their benefits. Data from the U.S. Centers for Disease Control and Prevention indicate that about ...

Ultrasound-triggered liposomes for on-demand, local anesthesia

August 10, 2017
Researchers at Boston Children's Hospital have found a new way to non-invasively relieve pain at local sites in the body; such systems could one day improve pain management by replacing addictive opioids and short-lasting ...

Independent pharmacies and online coupons help patients save money on drugs

August 8, 2017
Uninsured patients or those with limited prescription drug coverage can save significant money by buying their drugs at independent pharmacies instead of big box, grocery or chain drug stores and by using discount coupons, ...

New study generates more accurate estimates of state opioid and heroin fatalities

August 7, 2017
Although opioid and heroin deaths have been rising dramatically in the U.S., the magnitude of the epidemic varies from state to state, as does the relative proportion of opioid vs heroin poisonings. Further complicating the ...

Mind-body therapies immediately reduce unmanageable pain in hospital patients

July 25, 2017
Mindfulness training and hypnotic suggestion significantly reduced acute pain experienced by hospital patients, according to a new study published in the Journal of General Internal Medicine.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.