FDA advises consideration of risks and benefits
THURSDAY, Dec. 13 (HealthDay News) -- People who take the smoking cessation drug Chantix may be at increased risk for major adverse cardiovascular events (MACE), according to a Dec. 12 Drug Safety Coummnication bulletin posted by the U.S. Food and Drug Administration.
The agency's cautionary stance is based on the findings of a meta-analysis it insisted the manufacturer of Chantix conduct to evaluate the cardiovascular safety of the drug. The study revealed a higher rate of MACE in the 4,190 patients who took Chantix compared to the 2,812 who took a placebo. The difference between the two groups did not reach statistical significance but still raised concerns for those taking the drug.
The FDA advises health care professionals to weigh the risks of Chantix against its possible benefits, noting that smoking is a major risk factor for cardiovascular disease and that the drug has been shown to be effective in helping smokers quit.
The Agency suggests that health care professionals "counsel patients to seek medical attention if they experience new or worsening symptoms of cardiovascular disease while taking Chantix" and "encourage patients to read the Medication Guide they receive along with their Chantix prescription."
More Information (http://www.fda.gov/Drugs/DrugSafety/ucm330367.htm )