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.
