Navigation Links
Anti-Smoking Drugs Get FDA 'Black-Box' Warning
Date:7/1/2009

Reports link Chantix and Zyban to risk of psychiatric side effects, including suicidal thoughts,,

WEDNESDAY, July 1 (HealthDay News) -- 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.

For many users, the problems started soon after they began taking the drugs and ended when they stopped taking them. Some users, however, continued to have symptoms even after stopping the drugs. In a few cases, the problems started after the drugs were stopped, Rosebraugh said.

People taking these drugs who develop any of these symptoms should be monitored until their symptoms clear up, even if symptoms develop after stopping these drugs, Rosebraugh added.

The drugs don't contain nicotine, and some of the symptoms may be caused by nicotine withdrawal. People who stop smoking can suffer from depression, anxiety, irritability, restlessness, and sleep disturbances, the FDA noted.

Some patients who were using the drugs experienced the side effects while they were still smoking, the agency said.

Rosebraugh said the risk of using these drugs needs to be balanced with the substantial benefits of quitting smoking, and these drugs can be very effective.

"Stopping smoking is a goal we all want to work towards, and if people need medication to do it they should have access to it. So we don't want to scare people off from trying to use a medication to stop smoking; we just want them to be carefully monitored," he said.

In addition to the warning, the FDA is requesting more prescribing information in the warning section of the label, and new information in the Medication Guide for patients that discusses the risk of mental health events while using these products.

The makers of the drugs will also be required to do a clinical trial to see how often serious psychiatric symptoms occur in patients using a variety of therapies to help them quit smoking, including patients who currently have psychiatric disorders, Rosebraugh said. Results of this trial won't be known for several years, he added.

Chantix is manufactured by Pfizer Inc. Zyban is made by GlaxoSmithKline.

"The labeling update underscores the important role of health-care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely," Dr. Briggs W. Morrison, senior vice president for the Primary Care Development Group at Pfizer, said in a prepared statement. "Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex."

The FDA's review of consumers using nicotine patches did not find a link between patches and psychiatric side effects.

The antidepressant Wellbutrin, which contains the same active ingredient as Zyban, already carries a black-box warning.

More information

For more on how to quit smoking, visit the U.S. Centers for Disease Control and Prevention.



SOURCE: July 1, 2009, teleconference with Curt Rosebraugh, M.D., M.P.H., director, Office of Drug Evaluation II, U.S. Food and Drug Administration


'/>"/>
Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Obama Signs Tough New Anti-Smoking Law
2. BODY WORLDS Exhibition Uses Lung Specimens to Launch Anti-Smoking Campaign at the San Diego Natural History Museum
3. Statewide Anti-Smoking Campaign Takes New Approach in Curbing Teen Smoking
4. America Reaches Major Anti-Smoking Milestone
5. Anti-Smoking Web Site Helps Parents Plug Into Prevention
6. More Movies to Include Anti-Smoking PSAs to Protect Childrens Health
7. Entertainment Industry Foundation Unites Major Studios and State of California for Historic Anti-Smoking Campaign
8. Advisory: Entertainment Industry Foundation, Gov. Schwarzenegger to Announce Major Hollywood Anti-Smoking Initiative
9. Anti-smoking strategy targets fourth-graders, parents in rural and urban Georgia
10. Muslim Groups Kick Off Ramadan With Anti-Smoking Initiative
11. The National Council on Aging and CVS/pharmacy Educate Pennsylvania Seniors on Medication Management and How to Save Money on Prescription Drugs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2017)... ... April 28, 2017 , ... ... with the Home Care Association of America (HCAOA). This agreement allows HCAOA members ... services, as well as discounts on Accreditation University (AU) educational resources that help ...
(Date:4/28/2017)... (PRWEB) , ... April 28, 2017 , ... ... to announce the integration of Microsoft(R) Word(TM) Online(TM), which enables sleep physicians to ... since it streamlines the reporting process and provides a familiar interface that does ...
(Date:4/28/2017)... ... 2017 , ... Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ) announced ... its outlook as “stable.” At the same time, the ratings agency cautioned that the ... dip below “capital adequacy” thresholds required for its strong rating. , “Horizon is committed ...
(Date:4/28/2017)... ... April 28, 2017 , ... GlycoMark, Inc. announced today ... throughout the Northeast U.S. , GlycoMark is the only clinically available blood ... provides a clinically proven one- to two-week measure of hyperglycemic excursions, often related ...
(Date:4/28/2017)... ... April 28, 2017 , ... Ushio America ... lamps offer an instant energy-saving solution for F32T8 fluorescent lamps on most instant-start ... ballasts. These 50,000 hour rated lamps utilize the existing electronic ballast, saving labor ...
Breaking Medicine News(10 mins):
(Date:4/24/2017)... 2017 Solentim, the developer of instrumentation ... of a major new product line called the ... VIPS has been developed for automatically seeding single ... part of the process to generate clonally-derived cell ... more reliable solution when compared to traditional single ...
(Date:4/20/2017)... , April 20, 2017 ... "Global Biosimilar Pipeline and Market Prospects: Addressing Production ... report to their offering. ... "Global Biosimilar Pipeline and Market Prospects: ... Design" provides an in-depth assessment of the current trends ...
(Date:4/20/2017)... April 20, 2017  AbbVie (NYSE: ABBV), a ... (n=145/146) of chronic hepatitis C virus (HCV) infected ... 6 and compensated cirrhosis (Child-Pugh A) achieved sustained ... ) with its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir ... seen following 12 weeks of G/P treatment without ...
Breaking Medicine Technology: