Pfizer is facing more trouble over its controversial stop-smoking drug, Chantix. Regulators in France, where Chantix is sold as Champix, have decided to remove the medication from the country’s list of approved drugs. This means Chantix users in France won’t be able to receive reimbursement for the drug from the country’s social security fund.
In announcing the move, France’s Health Minister cited a concern over Chantix side effects, especially its association with violent and suicidal behavior.
“Questions have been raised about Champix, so I’ve decided it will no longer be covered by (state) health insurance,” Xavier Bertrand said during French television interview, according to a Reuters report.
According to a report from Fierce Pharma, the French decision is only the latest setback for Chantix. Only a week prior, a coroner in Tasmania warned Champix users there to be aware of potential side effects. The warning came after a Tasmanian Champix user committed suicide.
In 2009, the Food & Drug Administration (FDA) mandated that Pfizer add a Black Box Warning to the Chantix label in the U.S. regarding its association with changes in behavior, depression and suicidal thoughts. Since then, Chantix has been associated with more reports of disturbing behavior.
The drug has also been named in various lawsuits that charge it caused users to suffer psychiatric side effects. Most recently, the estate of a Pennsylvania couple who died in a 2009 murder-suicide sued Pfizer, claiming the husband’s use of Chantix caused the tragedy. As we reported at the time, the FDA mandated the Chantix Black Box warning just weeks after the couples’ deaths.
Last month, it was learned that large number of potential Chantix side effects – including 150 suicides – were not properly reported to the FDA. According to a report from the Institute for Safe Medicine Practices (ISMP), the 589 reports of severe side effects – which also included instances of attempted suicide, depression, aggression and hostility -were improperly mixed into reports of minor side effects. The ISMP said the botched reporting may have obscured the true seriousness of Chantix psychiatric side effects.