France has decided to stop paying for Pfizer's stop-smoking drug Champix. The treatment, sold as Chantix in the U.S., will be pulled from the government formulary of meds eligible for reimbursement because of ongoing controversy about its potential side effects, Health Minister Xavier Bertrand said.
"Questions have been raised about Champix, so I've decided it will no longer be covered by (state) health insurance," Bertrand said in a television interview (as quoted by Reuters). As the news service reports, the FDA in 2009 called for new warnings about potential psychiatric effects from Chantix use.
The FDA warning came after a wave of complaints about Champix/Chantix. Hundreds of patients reported psychiatric side effects ranging from outbursts of anger to suicidal thoughts. One of those patients--a member of the band The New Bohemians--made headlines when he went into a rage, confronted a noisy neighbor and was shot to death. The patient's girlfriend blamed Chantix for his uncontrolled anger.
And just last week, a Tasmanian man committed suicide; a coroner there warned Champix users to be on the lookout for psychiatric symptoms. In early May, a Pennsylvania couple's estates sued Pfizer, alleging that the stop-smoking drug caused their murder-suicide. Sean Wain, who had been taking Chantix, killed his wife and himself in May 2009.
Meanwhile, two weeks ago, a non-profit watchdog claimed Pfizer had misreported adverse Chantix events to the FDA, delaying 589 reports of severe side effects, including 150 suicides. The adverse events also included suicide attempts, depression, aggression and hostility, MSNBC reports. They were allegedly mixed into reports of minor side effects such as nausea and rash.
Pfizer has said that it fully complied with FDA reporting requirements. The company stands by Chantix's safety, saying there's no proof it causes suicide or other serious side effects. Pfizer in the past has pointed out that the stress of quitting smoking can in itself cause depression and other psychological symptoms. And after the news of misreported side effects was released, the FDA said that the new numbers didn't change its estimation of Chantix's risk-benefit profile.
- read the Reuters news
- see the MSNBC story