F.D.A. Investigates Quit-Smoking Drug
From New
York Times
By The Associated Press
Published: November 21, 2007
WASHINGTON, Nov. 20 (AP) - Government scientists are investigating whether a drug from Pfizer used to help smokers quit cigarettes also increases suicidal thoughts and violent behavior.
The Food and Drug Administration said on Tuesday that it had received reports of mood disorders and erratic behavior among patients taking Chantix, Pfizer's prescription drug used to help quit smoking.
The F.D.A. said it was still gathering information about the drug, but advised doctors to closely monitor patients taking Chantix for behavior changes. Sales of the drug totaled $101 million last year.
The agency said it was investigating at least one incident involving Chantix and a violent death.
Family members of a musician in Dallas, Carter Albrecht, recently said that Chantix might have caused the rage that led to his death. Mr. Albrecht was shot in the head in September by his girlfriend's neighbor as he tried to kick down the man's door. An autopsy report showed that Mr. Albrecht's blood alcohol level was three times the legal limit.
The agency said it had asked Pfizer for information on additional cases that might be similar.
Regulators said it was unclear if Chantix was directly responsible for the behavior, because nicotine withdrawal often aggravates existing mental problems.
Pfizer, which is based in New York, also submitted reports to the agency on increased drowsiness among patients taking Chantix.
By The Associated Press
Published: November 21, 2007
WASHINGTON, Nov. 20 (AP) - Government scientists are investigating whether a drug from Pfizer used to help smokers quit cigarettes also increases suicidal thoughts and violent behavior.
The Food and Drug Administration said on Tuesday that it had received reports of mood disorders and erratic behavior among patients taking Chantix, Pfizer's prescription drug used to help quit smoking.
The F.D.A. said it was still gathering information about the drug, but advised doctors to closely monitor patients taking Chantix for behavior changes. Sales of the drug totaled $101 million last year.
The agency said it was investigating at least one incident involving Chantix and a violent death.
Family members of a musician in Dallas, Carter Albrecht, recently said that Chantix might have caused the rage that led to his death. Mr. Albrecht was shot in the head in September by his girlfriend's neighbor as he tried to kick down the man's door. An autopsy report showed that Mr. Albrecht's blood alcohol level was three times the legal limit.
The agency said it had asked Pfizer for information on additional cases that might be similar.
Regulators said it was unclear if Chantix was directly responsible for the behavior, because nicotine withdrawal often aggravates existing mental problems.
Pfizer, which is based in New York, also submitted reports to the agency on increased drowsiness among patients taking Chantix.