The FDA issued a warning to patients and doctors on Thursday regarding the results of a new study linking use of the anti-smoking drug, Chantix, to an increased risk for developing heart problems. The agency’s warning followed reports from a 700-person trial in which patients who took Chantix for more than 12 weeks were more likely to experience heart problems than those who were given a placebo. While the risk for heart attack was small, 7 out of 353 patients taking Chantix did experience a heart attack, versus only 3 out of the 350 patients who were given the placebo.
Chantix is no stranger to FDA warnings. In 2009, the agency informed doctors and patients that use of the drug may increase the risk of severe adverse reactions such as depression and suicidal thoughts and behaviors. As a result, Chantix currently carries a black box warning regarding the risk for developing these serious side effects. The FDA will also add new warnings to the drug’s label about the findings linking Chantix to an increased risk for heart attack and cardiovascular problems.
The drug’s manufacturer, Pfizer, will be required to better analyze and further assess the real risk of heart attack associated with use of its product. In the meantime, the FDA urges patients currently taking Chantix to consult their physician regarding any new or worsening symptoms of a heart problem, such as chest pain or difficulty breathing.
