The FDA says Pfizer's ($PFE) smoking-cessation drug Chantix is probably the cause of higher risk for heart attacks among those who use it, but it can't be sure. It says it's certain that smoking can kill you and Chantix can help some people stop.
The agency statement says a meta-analysis of clinical trials for the controversial drug charted a higher rate of heart attacks or strokes in patients using the treatment than in those who took placebos. The results were not statistically significant, the FDA said, but it appears "more likely that it is related to the drug and not purely a chance finding," the agency said.
Chantix has been tied to heart risks and to risk of suicide, which its label warns against. As Bloomberg points out, the FDA last year asked Pfizer to further study the risks with the extended analysis. The agency's announcement Wednesday followed that analysis.
Pfizer has been battling a number of lawsuits related to health concerns. The company recently settled some by families who say members killed themselves after taking Chantix. The lawyers for one claimant recently got a court to agree that they could put Pfizer CEO Ian Read on the stand to testify about Chantix.
The FDA was adamant in reminding people that there are huge heart risks tied to smoking and that the benefits of stopping the habit are "immediate and substantial." It suggests doctors and patients take all of that into consideration when deciding if they should use Chantix.
- here's the FDA announcement
- read the Bloomberg story