A new international study, led by researchers at Johns Hopkins University has found the drug Chantix increased the risk of hospitalizations for heart problems by 72 percent.
The study, analyzed 14 Pfizer-sponsored drug trials with 8,216
patients and found about one new heart attack or similar disorder
for every 400 patients taking Chantix. In all, of the 4,908 people
taking Chantix, 52 experienced serious cardiovascular problems such as heart attack or arrhythmia (abnormal heart rhythm) compared with 27 of the 3,308 taking dummy drugs. The new analysis shows the greatest increased risk may be among patients with no signs of heart problems, said Sonal Singh,lead author of today’s study.
“I stopped prescribing Chantix several months ago, as soon as we found out about this data,” said Singh, a doctor and professor at Johns Hopkins University School of Medicine in Baltimore. “I’m not saying that nobody should use it, but I think people should have this information. They should decide whether the risk is acceptable to them.” The FDA warned in 2009 that the medicine may increase suicides and erratic behavior. Regulators last month added a warning for patients with a history of heart disease, based on a recent 700-patient study. The studies included in today’s report ranged from 7 to 52 weeks in duration. It’s not clear whether the added heart risk persists after treatment ends, Singh said.
Writing in the Canadian Medical Association Journal, researchers said: “Clinicians should carefully balance the risk of serious cardiovascular events associated with varenicline (Chantix), use against the known benefits of the drug on smoking cessation.
A spokesman for Pfizer, which makes the drug, said the company “disagreed with the interpretation of the data” in the study, which it said had “limitations”.