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, anxiet
'/>"/>

Copyright©2009 ScoutNews,LLC.
All rights reserved

0

GOOD

Page: 1 2 3

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:5/24/2013)... 2013 According to the National Institutes of ... epidermal necrolysis (TEN) that affects the skin and mucous membranes. ... under the age of 30 (i). In the early ... fever. As SJS advances, it affects the mucous membranes ... anus. Inflammation of the eye causes conjunctivitis (pink eye). ...
(Date:5/24/2013)... BEACH, CA (PRWEB) May 24, 2013 ... health care education community, proudly participated in festivities surrounding ... April 19-21. The event provided the perfect backdrop to ... facilities at 236 E. 3rd Street, housed in an ... Arts Building. , ACC was an active exhibitor throughout ...
(Date:5/24/2013)... FRIDAY, May 24 (HealthDay News) -- About one in ... their teens take up smoking, drinking or illicit drug ... too bad, say experts at the Substance Abuse and ... that parents are actually one of the most influential ... issues. "Surveys of teens repeatedly show that ...
(Date:5/24/2013)... May 2013, Paris, France: Routinely measuring fractional flow ... angiography for diagnosis of chest pain leads to ... four patients, according to results from a study ... routine pressure wire assessment influence management strategy at ... was designed to assess whether routine assessment of ...
(Date:5/24/2013)... youth and diabetes keeps getting worse. The latest data from ... Type 2 diabetes are at high risk to develop heart, ... than people who acquire Type 2 diabetes as adults. ... to be at very high risk for early complications when ... endocrinology in the School of Medicine at The University of ...
Breaking Medicine News(10 mins):Health News:Personal Injury Law Firm Issues New Infographic Detailing a Potential Link Between Stevens Johnson Syndrome and Common Children’s Medicines 2Health News:Personal Injury Law Firm Issues New Infographic Detailing a Potential Link Between Stevens Johnson Syndrome and Common Children’s Medicines 3Health News:American Career College Revs Up Community Support During Toyota Grand Prix of Long Beach 2Health News:Parents Underestimate Influence Over Teens' Substance Abuse: Survey 2Health News:Diagnostic coronary angiography: Functional flow reserve changes decisions in 25 percent of cases 2Health News:Youth with type 2 diabetes at much higher risk for heart, kidney disease 2
... CHAPEL HILL, N.C., May 27 As the ... companies are looking,for ways to up-sell and cross-sell ... the need for such practices, Best Practices LLC ... from less than 5% of their,service calls., ...
... NY/LOS ANGELES, CA: Stand Up To Cancer ... philanthropic dollars for accelerating ground-breaking research, launches today ... networks, entertainment industry executives, celebrities and prominent leaders ... CBS and NBC will donate one hour of ...
... TUCSON, Ariz., May 27 Medipacs, Inc., a ... is has secured an,initial financial investment of $1.65 ... Venture Partners and other investors in Tucson, San,Diego, ... Mark McWilliams comments: "We are very pleased with,the ...
... IMTEC Corporation proudly,introduces a newly redesigned version ... works in conjunction with IMTEC,s proprietary,FlashCT(R) software for ... scanner, Vision provides users with tools for viewing, ... may be in the form of,a raw scan ...
... in Melanoma , Mutations in the p14ARF tumor ... independent of the effect of the p16 gene. , ... on chromosome 9 that is frequently mutated in melanomas. ... p16 tumor suppressor gene occurs frequently in melanomas, it ...
... days off, poor-quality output, study finds , , TUESDAY, May ... hyperactivity disorder (ADHD) miss, on average, more than three ... new global reckoning of the problem. , Altogether, between ... ADHD, according to survey data from the World Health ...
Cached Medicine News:Health News:ABC, CBS, NBC announce historic collaboration to 'stand up to cancer' 2Health News:ABC, CBS, NBC announce historic collaboration to 'stand up to cancer' 3Health News:ABC, CBS, NBC announce historic collaboration to 'stand up to cancer' 4Health News:ABC, CBS, NBC announce historic collaboration to 'stand up to cancer' 5Health News:ABC, CBS, NBC announce historic collaboration to 'stand up to cancer' 6Health News:IMTEC Introduces New Vision Software 2Health News:Also in the May 27 JNCI 2Health News:Also in the May 27 JNCI 3Health News:Also in the May 27 JNCI 4Health News:Adults With ADHD Lose 3 Weeks Worth of Work Annually 2Health News:Adults With ADHD Lose 3 Weeks Worth of Work Annually 3
(Date:5/24/2013)... and BOSTON , May 24, 2013 /PRNewswire/ ... development company, is pleased to announce that it has engaged Mr ... the Company,s business development capabilities in Japan ... 15 years of experience in business development, licensing and alliance management ... Roche Pharma ( Japan ), Nippon Roche and Tanabe ...
(Date:5/23/2013)... DIEGO y PARÍS, 24 de mayo ... VOLC ), un destacado desarrollador y fabricante de ... mejorar la diagnosis y tratamiento de la enfermedad ... preliminares del ensayo ADVISE ( Ad enosine ... E valuation) II durante la sesión de ...
(Date:5/23/2013)... May 23, 2013  Haemonetics Corporation (NYSE: HAE ... CFO & EVP-Business Development, will present at The Deutsche Bank ... Boston, MA on May 29, 2013 at ... ) The public may access Mr. Lindop,s presentation ... About Haemonetics Haemonetics (NYSE: HAE ) ...
Breaking Medicine Technology:Heptares Augments Business Development Capabilities in Japan and Other Asian Territories 2Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 2Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 3Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 4Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 5Volcano anuncia los resultados preliminares del estudio ADVISE II y su inclusión en el ensayo SYNTAX2 6
... 21, 2010 /PRNewswire-FirstCall/ – ERT (Nasdaq: ERES ... the pharmaceutical, biotechnology and medical device industries, today confirmed ... of Dr. Michael J. McKelvey, its President and CEO, ... currently ERT,s Chairman and Chief Scientific Officer, has also ...
... 21, 2010 PTC Therapeutics, Inc. announced today that ... trial of ataluren, an investigational new drug, in patients ... http://photos.prnewswire.com/prnh/20010919/PTCLOGO) The 48-week study is designed to ... with nmCF.  The trial has enrolled 238 patients at ...
Cached Medicine Technology:ERT Announces the Appointment of Joel Morganroth, MD as Interim CEO 2ERT Announces the Appointment of Joel Morganroth, MD as Interim CEO 3PTC Therapeutics Completes Enrollment of Phase 3 Trial of Ataluren in Patients with Cystic Fibrosis 2PTC Therapeutics Completes Enrollment of Phase 3 Trial of Ataluren in Patients with Cystic Fibrosis 3PTC Therapeutics Completes Enrollment of Phase 3 Trial of Ataluren in Patients with Cystic Fibrosis 4
... is designed to play a key ... research involves proteomics, cytomics or genomics. ... enhanced firmware, powerful Optima eXPert software ... L-XP delivers superior functionality, optimized user ...
... integrated chemistry system brings versatility in ... smaller laboratory. A model of innovation ... chemistry system features state-of-the-art Dimension testing ... environment, in a flexible. affordable, easy-to-use ...
The Express Plus clinical chemistry analyzer is a fully automated walk away system designed for maximum productivity, convenience and reliability....
... convenience make the RD/Hitachi 902 the ... workload laboratory. Compact, sample selective clinical ... 26 tests on board (including 3 ... tests per hour respectively up to ...
Medicine Products: