Black Box Warnings Removed From Chantix, Zyban

From the WebMD Archives

Dec. 19, 2016 -- The anti-smoking drug Chantix no longer has to carry a bold-letter warning about possible psychiatric side effects, the U.S. Food and Drug Administration says.

The black box warning about the risks of side effects such as suicidal tendencies, hostility and depression was introduced in 2009, the Associated Press reported.

But the FDA announced Friday that the Pfizer drug no longer had to carry the agency's most serious warning label. The decision was based on an 8,000-patient study of smokers that found no increased risk of psychiatric problems among Chantix users who had no previous history of mental illness.

Based on the same data, European regulators previously removed a similar warning from Chantix.

The FDA also announced Friday that a black box warning about possible psychiatric side effects is no longer required on Zyban, an anti-smoking drug marketed by GlaxoSmithKline PLC, the AP reported.

Information about psychosis, paranoia, anxiety and other problems will still have to be listed on the labels of Chantix and Zyban, just not within a black box warning.

"The risk of these mental health side effects is still present, especially in those currently being treated for mental illnesses such as depression, anxiety disorders, or schizophrenia, or who have been treated for mental illnesses in the past," according to an FDA online post, the AP reported.