Pfizer Boosts Caution On Anti-Smoking Drug

If the quitting treatment makes you want to kill yourself, why not just keep on smoking?
Pfizer said on Friday that it has beefed up its warning on Chantix, a popular anti-smoking treatment, to include language cautioning users about the potential for depression and suicidal behavior. The pharmaceutical maker has recently come under pressure from the U.S. Food and Drug Administration as patients have reported erratic behavior and mood disorders while taking Chantix. The FDA is currently reviewing the drug's safety.
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.
It is especially difficult to evaluate the cause of these negative symptoms, as they could be attributed to the nicotine withdrawal rather than Chantix. Yet, some patients who had pre-existing psychiatric illnesses experienced a worsening of their condition while taking Chantix.
"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.
Perhaps the most famous cases against Chantix is the death of folk-rock musician Carter Albrecht, former member of the groups Edie Brickell and the New Bohemians. Albrecht was shot to death in Dallas after a night of strange and uncharacteristically violent behavior. His father says his son was a happy-go-lucky session man, but in the week after he started taking Chantix he became combative over what used to be minor business details. In addition to having taken Chantix, Albrecht was drinking heavily the night he was shot; his blood-alcohol level was three times the legal limit for driving.