U.S. orders suicide warnings on two anti-smoking drugs

By Susan Heavey, Reuters

WASHINGTON (Reuters) - U.S. health officials on Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong "black box" warnings on their anti-smoking drugs to highlight the risk of serious mental health problems, including suicidal thoughts.


The warnings, which must be added to Pfizer's Chantix and Glaxo's Zyban, follow more than five thousand reports of depression, hostility and other behavioral changes, the Food and Drug Administration said.


FDA officials said there was still a need for the medications, their concerns tempered by smoking's health dangers, such as lung cancer and heart disease.


"We don't want to scare people off from trying to use the medication to stop smoking. We just want them carefully monitored," said Dr. Curt Rosebraugh, who oversees the FDA office that reviews smoking-cessation drugs.


Additionally, the FDA strengthened its caution about possible accidents and serious injuries with Chantix linked to loss of consciousness, mental confusion, dizziness and muscle spasms. But it stopped short of adding it to the boxed warning as some health advocates had urged.


Rosebraugh told reporters the FDA could not directly link the reported problems to the drugs, adding that withdrawal from nicotine in tobacco can also cause problems.


The agency is also requiring the companies to conduct additional clinical trials to help determine how serious a problem the mood disorders are, including among patients who already have depression or other similar conditions.


The warnings will limit Pfizer's ability to run some types of advertisements for Chantix, which the world's largest drugmaker had been counting on to help revive profits.


Instead, Pfizer has seen the drug's sales plunge over the last year amid safety concerns. Global first-quarter sales of Chantix fell 36 percent to $177 million.


THOUSAND OF REPORTS


FDA first alerted patients and doctors about possible mood changes with Chantix in November 2007, and has continued to receive reports of problems.


Overall, the agency received 4,762 reports of serious psychiatric events since Chantix's 2006 approval. For Zyban and its generic rivals, it received a total 527 reports, it said.


Specifically, the FDA said it received 98 reports of suicide and 188 reports of attempted suicide with Chantix and 14 reports of suicide and 17 attempts with Zyban and related generics.


Some analysts said investors have already factored in the continuing safety concerns. BMO Capital Markets analyst Robert Hazlett said he was lowering his estimated Chantix sales by $50 million per year starting in 2010.


Pfizer shares finished down less than 1 percent at $14.90 on the New York Stock Exchange on Wednesday. Glaxo shares gained 2 percent to close at $36.04, also on the NYSE.


Chantix, also known as varenicline, is designed to stimulate a type of nicotine receptor in the brain while preventing nicotine from binding to another receptor.


Zyban includes the same active ingredient, bupropion, as Glaxo's antidepressant Wellbutrin, which already carries a boxed warning about suicide and other behavioral risks.


Both Pfizer and Glaxo said they would add the new warning to their products.


Pfizer said it has already begun studying Chantix in hundreds of schizophrenia patients and was planning another trial that would include people with and without psychiatric disorders.


"The benefits of Chantix outweigh the risks for many patients when used as directed," said Dr. Briggs Morrison, a Pfizer senior vice president.


But some consumer advocates said the FDA's Chantix warning was not strong enough for a drug that has been banned for use by pilots.


Thomas Moore, a scientist at the Drug Safety and Policy Institute for Safe Medication Practices, said making the accident caution more prominent was an improvement but it should be as strong as the one for mental side effects.


"Both doctors and patients should carefully weigh the risks and benefits of this drug... and consider alternatives" such as nicotine patches and gums, said Moore, whose group called attention to reported accidents and injuries last year.


(Reporting by Susan Heavey with additional reporting by Lisa Richwine in Washington and Ransdell Pierson in New York; editing by Maureen Bavdek, Richard Chang and Tim Dobbyn)

© Copyright (c) Reuters

http://www.canada.com/life/parenting/orders+suicide+warnings+anti+s...

Views: 33

Comment

You need to be a member of 12160 Social Network to add comments!

Join 12160 Social Network

"Destroying the New World Order"

TOP CONTENT THIS WEEK

THANK YOU FOR SUPPORTING THE SITE!

mobile page

12160.info/m

12160 Administrators

 

Latest Activity

tjdavis posted a blog post
yesterday
Doc Vega posted a blog post
yesterday
Doc Vega posted blog posts
Tuesday
Doc Vega posted blog posts
Monday
Doc Vega favorited tjdavis's photo
Sunday
Doc Vega commented on tjdavis's photo
Thumbnail

Game Night

"Ha! Good one!"
Sunday
Doc Vega commented on FREEDOMROX's blog post MRNA VACCINES: Question
"Listen man I know where you're at but back in October of 2023 thru December of 2023 for months…"
Sunday
tjdavis posted a video

Architecton | Official Trailer HD | A24

SUBSCRIBE: http://bit.ly/A24subscribeWritten and directed by Victor Kossakovsky and starring Michele De Lucchi. ARCHITECTON – Coming Soon RELEASE DATE: Comin...
Sunday
tjdavis posted photos
Sunday
tjdavis posted a blog post
Sunday
Burbia posted a video

Europe Will Not Survive

The hubris.All things Archaix at www.archaix.com
Sunday
FREEDOMROX posted a video
Saturday
Burbia commented on tjdavis's blog post Track AIPAC
Jun 20
rlionhearted_3 commented on Doc Vega's blog post Latest Details on Missile Exchanges Between Iran and Israel
"May get really ugly over there?"
Jun 20
Doc Vega posted a blog post

Latest Details on Missile Exchanges Between Iran and Israel

Latest information about the air attacks between Israel and Iran as the US moves another carrier…See More
Jun 19
tjdavis favorited Less Prone's video
Jun 19
tjdavis posted a blog post
Jun 19
cheeki kea replied to cheeki kea's discussion Tartaria
"Some interesting information has come to light ( from the renaissance period ) which explains that…"
Jun 19
Sandy posted a video
Jun 19
John Miller replied to MAC's discussion BREAKING! UFO whistleblowers drop BOMBSHELL on D.C. | Redacted with Natali and Clayton Morris
"Yes, the whole whistleblower situation is getting more intense, especially with all these bombshell…"
Jun 18

© 2025   Created by truth.   Powered by

Badges  |  Report an Issue  |  Terms of Service

content and site copyright 12160.info 2007-2019 - all rights reserved. unless otherwise noted