FDA has another look at Chantix

Share this article:

Pfizer has submitted new FDA-requested data for its prescription smoking-cessation drug Chantix, which will be part of an upcoming review regarding the drug's psychiatric and behavioral impacts.

The Associated Press reports that the FDA plans to hold a public hearing about the drug in October. The drug has carried a black box warning since 2009 because of its association with hostility, agitation, depression and suicidal thoughts. The FDA asked for these additional studies at that time. Pfizer said in a statement that the drugmaker has proposed modifying the label based on this additional data.

The AP notes that two of the studies contributing to the data set do not indicate an increased rate of hospitalization for psychiatric reasons compared to the placebo group. The AP also says authors indicate that the focus on psychiatric hospitalization means it is likely many issues were not reported.

Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Novartis apologizes for slow reporting

Novartis is apologizing to Japan after the Ministry of Health, Labor and Welfare said the company had dragged its feet reporting adverse events for two of its cancer drugs.

J&J pulls morcellator from market

The company is calling the move a withdrawal, as opposed to a recall.

Pfizer buys two Baxter vaccines

The meningitis and encephalitis medications earned a combined $300 million last year.