Navigation Links
Quit-Smoking Drug May Raise Suicide Risk
Date:2/1/2008

FDA asks maker of Chantix to revise warning on product label

FRIDAY, Feb. 1 (HealthDay News) -- There's increasing evidence that the smoking-cessation drug Chantix is linked to serious "neuropsychiatric" side effects, including agitation, depressed mood and even suicide, U.S. health officials said Friday.

The U.S. Food and Drug Administration has asked Chantix's manufacturer, Pfizer Inc., to make the warning about these potential problems more prominent on prescribing information and on the drug's label. The agency is also working with Pfizer to produce a Medication Guide for patients, officials said.

"We have become increasingly concerned as we have seen a number of compelling cases that truly look as if they are the result of exposure to the drug and not to other causes," Dr. Bob Rappaport, director of the FDA's Division of Anesthesia, Analgesia and Rheumatology Products, said during an afternoon teleconference.

"These cases involve abnormal behaviors, changes in mood, and suicidal ideation and suicide," Rappaport said.

The FDA knows of 491 cases of suicidal behavior associated with Chantix, said Dr. Celia Winchell, a team leader in the FDA's Division of Anesthesia, Analgesia and Rheumatology Products.

"Of these, 420 are from the United States," Winchell said. "There are 39 that involve completed suicides, 34 in the United States."

According to Pfizer, 5 million patients have taken Chantix, whose generic name is varenicline.

Friday's warning follows a Nov. 20 FDA statement that the agency was "evaluating post-marketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior."

At that time, Pfizer said there had never been a cause-and-effect relationship shown between Chantix and these symptoms. The company also said that part of the problem may be due to nicotine withdrawal.

Last month, Pfizer agreed, after consulting with the FDA, to update packages of Chantix sold in the United States to more prominently display a warning that users should be monitored for suicidal behavior, depressed mood, and other mental health symptoms.

The FDA approved Chantix in May 2006 as a smoking-cessation drug. It acts in areas of the brain affected by nicotine and may ease withdrawal symptoms and block the effects of nicotine if users resume smoking.

On Friday, FDA officials advised patients to tell their doctor about any history of psychiatric illness before starting Chantix. The drug can cause current psychiatric illness to get worse even if it is under control. Chantix may also cause the recurrence of an old psychiatric illness, the officials warned.

Patients should also report changes in mood and behavior to their doctor. Symptoms to look out for include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide, the FDA officials said.

In most cases, these symptoms developed while taking Chantix, but they can also appear after stopping the drug, the officials noted.

"We are continuing with the review process over the next several months as we try to pin down to what extent these problems are being seen with Chantix," Rappaport said.

Vivid, unusual, or strange dreams may occur while taking the drug. Patients may also experience impaired ability to drive or operate heavy machinery, the officials said.

More information

For more on quitting smoking, visit Smokefree.gov.



SOURCES: Feb. 1, 2008, teleconference with Bob Rappaport, M.D., director, and Celia Winchell, M.D., team leader, Division of Anesthesia, Analgesia and Rheumatology Products, Office of Drug Evaluation II, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Health Organizations Join Forces Around Quit-Smoking Help
2. New review suggests caution on drugs to raise good cholesterol
3. Antioxidant Supplements May Raise Womens Skin Cancer Risk
4. Acrylamide Wont Raise Breast Cancer Risk
5. The Philadelphia Walk Now for Autism Expected to Draw 10,000 Walkers and Raise $1 Million to Help Find Answers About the Nations Fastest-Growing Developmental Disorder
6. BlueCare(R) Family Plan, a HUSKY Health Plan from Anthem Blue Cross and Blue Shield in Connecticut, Raises Awareness, Funds and Diapers for New Haven Diaper Bank
7. Mercedes-Benz Special Edition C350 Sport Sedan to Raise $1 Million for Saks Fifth Avenues KEY TO THE CURE
8. Care reforms raise concerns over patient access to GP services
9. The Will and Jada Smith Family Foundation and Maybelline Join Forces With the Lupus Foundation of America for a Star-studded Gala to Raise Awareness for Lupus
10. Computer models help raise the bar for sporting achievement
11. Nautica Malibu Triathlon Presented by Toyota Raises $718,000 for Childrens Hospital Los Angeles Pediatric Cancer Research
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Quit-Smoking Drug May Raise Suicide Risk
(Date:10/13/2017)... , ... October 13, 2017 , ... PurhealthRX , ... Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize ... providing a CBD form that can be easily incorporated into liquid products, while reducing ...
(Date:10/13/2017)... N.Y (PRWEB) , ... October 13, 2017 , ... Lori ... became a member of ElderCounsel, a national organization of elder law and special needs ... changing laws and rules. It also provides a forum to network with elder law ...
(Date:10/13/2017)... ... , ... Many families have long-term insurance that covers care for a family ... for care if the client has a cognitive impairment diagnosis. , “What this ... often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, owner ...
(Date:10/13/2017)... York, NY (PRWEB) , ... October 13, 2017 , ... ... influential people in business to advocate for action towards gender equality at their inaugural ... views from around the globe, and reached a social audience of over 3 million. ...
(Date:10/13/2017)... Abilene, Texas (PRWEB) , ... October 13, 2017 , ... ... publication this week that explains one of the most popular and least understood books ... seems like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... 10, 2017  NDS received FDA 510(k) clearance in May 2017 ... display stand specifically designed for endoscopy environments. An innovative secondary monitor ... clinical solution to support the improvement of patient outcomes, procedural efficiency, ... ... ...
(Date:10/4/2017)... Oct. 4, 2017  According to the Centers for Disease Control and ... October . PhysicianOne Urgent Care is helping communities across Massachusetts ... , by offering no-cost* flu shots through the end of the ... certain health insurance regulations. ... time to get a flu shot is by the end of October, ...
(Date:10/2/2017)... Halo Labs announces the European launch of their new ... at MIBio 2017 in Cambridge, U.K on ... in biopharmaceutical samples with unprecedented speed and sensitivity while using far ... Membrane Imaging. ... particle analysis system ...
Breaking Medicine Technology: