Monday, July 6, 2009

FDA puts black box warnings on Chantix and Zyban

Reuters Health Day News reported on July 1, 2009 that the FDA has placed "black box warnings on two smoking cessation drugs: Chantix and Zyban. Here is a snippet from the article:

Two drugs prescribed to help people quit smoking, Chantix and Zyban, will now carry "black-box" warnings on the potential risks of psychiatric problems, including depression and suicidal thoughts, U.S. health officials said Wednesday.

The U.S. Food and Drug Administration said it was mandating the black-box warnings, the strictest possible, based on reports to the agency of these side effects and on a review of clinical trials and scientific literature.

"We are requiring the manufacturers of the smoking-cessation drugs Chantix and Zyban to add a new boxed warning highlighting the risk of serious mental health symptoms with use of these products," Dr. Curt Rosebraugh, director of the FDA's Office of Drug Evaluation II, said during a Wednesday teleconference.

The agency's review found that some people who used Chantix (varenicline) and Zyban (bupropion) experienced unusual changes in behavior, became depressed, or had their depression worsen and had thoughts of suicide or dying, the FDA said.

Rosebraugh said there were reports of 98 suicides and 188 suicide attempts involving Chantix, and 14 suicides and 17 attempts reported with Zyban.

You can read the whole article by clicking here.

To read the FDA News Release click here.

1 comment:

Medical Information said...

Chantix has shown success rate in cessation of the smoking habit. Many people on chantix have experienced side-effects like nauseous feeling, headaches, unpleasant dreams, lunacy, manic behaviour, bipolarity, delirium or schizophrenia. Also fatal accidents and suicides is informed. So FDA has issued black box warnings on chantix and zyban cautioning that doctors should mitigate the use of the drug by adopting a far observant attitude and supervise the patients. To get more information on this topic, refer Smoking cessation drugs