Suicide warning called for on stop-smoking drug
Christopher Elser and Elizabeth Lopatto
Saturday, December 15, 2007
Pfizer Inc.'s Champix, a stop- smoking aid, should carry a new warning about the risk of suicide attempts among patients, European health regulators said today.
In urging the warning, the London-based European Medicines Agency followed the lead of U.S. health officials who said last month that doctors should monitor patients for behaviour or mood shifts and that patients should tell their doctors of changes.
Pfizer has until Dec. 19 to propose new prescription information for the drug, the EMEA said Friday. Champix is sold under the Champix name Canada and Chantix in the U.S. The medicine is one of Pfizer's leading new drugs.
"There is a need to update the product information for Champix to warn doctors and patients that depression has been reported in patients who are trying to stop smoking using Champix," the European agency said. "The symptoms of this depression may include suicidal ideation and suicide attempt."
Last month, the U.S. Food and Drug Administration said it would study whether there is a link between the drug, used to break an addiction to smoking, and reports from Pfizer of suicidal thoughts among some users of the treatment.
The FDA's inquiry followed reports of bizarre behavior by musician Carter Albrecht of the band New Bohemians, who was taking Chantix, just before he was shot to death. Drugmakers and the FDA typically get multiple reports about side-effects after a drug is highly publicized.
"There is no scientific evidence establishing a causal relationship between Champix and these reported events" of suicide attempts, Pfizer spokesman Oliver Stohlmann said in an e-mailed statement. "Clinicians should be aware of the possible emergence of depressive symptoms in patients undergoing a smoking cessation attempt."
Symptoms of withdrawal from nicotine, the active ingredient in cigarettes, include depression, irritability, restlessness, headaches, frustration and anger, according to the American Cancer Society's discussion of smoking cessation on its website.
The most common adverse reaction to Chantix is nausea, followed by sleeplessness, according to the U.S. prescribing information. Other frequent side-effects are disturbances in attention and dizziness. Both are also side-effects of smoking cessation, according to the American Cancer Society.
"Pfizer is working closely with the EMEA to review post-marketing reports of depression and suicidal thoughts in patients taking Champix," said Pfizer spokesman Francisco Gebrauer in an e-mailed statement. The FDA has said that Chantix's role isn't clear because quitting smoking sometimes exacerbates underlying mental illness, Gebrauer said.
Albrecht was shot as he tried to kick in the door of his girlfriend's neighbour in Dallas in September. He had more than three times the legal driving limit of alcohol in his system when he died, the Dallas Morning News reported last month. His girlfriend told the newspaper that his behaviour was uncharacteristic and that he began acting strange shortly after he started taking Chantix.
The Dallas County medical examiner never tested whether Albrecht had Chantix in his bloodstream at the time of death.
© The Edmonton Journal 2007