Pfizer on Friday finally beefed up its warning on its stop-smoking drug, Chantix, to caution users about the increased potential for depression and suicidal behavior. The pharmaceutical maker has come under fire over the past year from patient advocacy groups, health bloggers, and the U.S. Food and Drug Administration as patients have reported erratic behavior and serious mood symptoms while taking Chantix.
Pfizer said it worked with the U.S. Food and Drug Administration to update an earlier label change enacted last year for Chantix.
The new label offers a similar recommendation to monitor patients, but the language is more prominently located to better get the attention of doctors, Pfizer officials said. The revised section is not a “black box,” a warning reserved for what the FDA deems the most dangerous potential adverse events.
The new label includes a warning that patients who are attempting to quit smoking by taking Chantix should be observed by a physician for serious neuropsychiatric symptoms like changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior. Pfizer noted that a causal relationship between Chantix and those neuropsychiatric symptoms has not been established. However, in some instances a relationship could not be ruled out.
“By putting this information in a more prominent location we’re hoping it will be included in the dialog between patients and physicians,” said Pfizer Vice President Ponni Subbiah. Pfizer plans to send letters regarding the updated warning to doctors as well as adding the information to its advertisements.
Chantix was approved in May of 2006 and has since been prescribed more than 4.0 million times in the U.S. alone. Jotham Coe, the inventor of Chantix, was originally assigned to Pfizer’s anti-smoking project in 1995. The goal was to create a drug that could gently hug nicotinic receptors, easing cravings without getting the smoker high. After eight years of clinical trials in 5,000 patients, Chantix hit the market with a bang before reports of serious psychological side effects began trickling in.
The drug has been prescribed to 4 million people in the United States since approval in 2006, according to Pfizer.
The FDA is currently also reviewing the drug’s safety.
Source: News wire