BioSpace Collaborative

Academic/Biomedical Research
News & Jobs
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

PROFILES
Company Profiles

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Research Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
Get Our Industry eNewsletter FREE email:    
   

Pfizer Inc. (PFE)'s Chantix Produced More Heart Concerns, FDA Says


12/13/2012 7:54:11 AM

Pfizer Inc. (PFE)’s anti-smoking drug Chantix produced a higher rate of heart attacks or strokes in patients using the treatment than those who didn’t take the product, according to an analysis of clinical trials. The number of cardiovascular issues in patients on Chantix and those who took a placebo was uncommon, the U.S. Food and Drug Administration said today in a safety notice on its website. While the increased risk wasn’t statistically significant for those on Chantix, it seems “more likely that it is related to the drug and not purely a chance finding,” the agency said. Chantix carries a warning that it raises the risks of suicide and may be tied to higher heart danger in patients with cardiovascular disease. The warning label had been changed last year after regulators cited the heart concerns and asked New York-based Pfizer to further evaluate the risks with a large analysis of existing studies of the drug. The agency’s announcement today followed that analysis. Of 4,190 Chantix users, 13 were found to have experienced a major cardiovascular event such as heart attack or stroke compared with six of 2,812 who took a placebo in 15 Pfizer- sponsored clinical trials, the FDA said. The benefits of Chantix outweigh the risks, MacKay Jimeson, a spokesman for Pfizer, said in an e-mail. “The benefits of quitting smoking are immediate and substantial,” Jimeson said. “Chantix has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo.” Smoking is a major risk factor for heart disease, the FDA said. Patients taking Chantix should contact their doctor if they experience new or worsening symptoms of cardiovascular disease, such as chest pain, shortness of breath, calf pain or sudden onset of weakness, numbness or difficulty speaking. Chantix generated $720 million in sales last year for Pfizer, the world’s largest drugmaker, according to data compiled by Bloomberg. The FDA notice said that about 2.3 million Chantix prescriptions were dispensed in the year ended in September.

Read at Bloomberg
Read at Forbes
Read at PharmaLive

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES
 

//-->