Dec 10, 2007 2:07 pm US/Central
Warnings For Anti-Smoking Pill Linked To Suicide
FORT WORTH (CBS 11 / TXA 21) ―
A drug designed to curb cigarette cravings will carry new warnings of links with suicidal thoughts when it hits the Australian market next month.
Packs of Champix, marketed as Chantix in the United States, will now contain extra information warning that some patients have suffered from depression, agitation and suicidal thoughts while taking the drug.
Doctors in Australia have also been mailed letters informing them of the changes. The Australian Associated Press reports Australia's Therapeutic Goods Administration (TGA) had reviewed reports submitted to the U.S. Food and Drug Administration and ordered drug company Pfizer to issue "Dear Doctor" letters. Champix goes on the market in Australia on January 1.
A TGA spokeswoman said Pfizer has also included a new warning on Champix, stating "there have been reports of depressed mood, agitation, changes in behavior, suicidal ideations and suicide in patients attempting to quit smoking while taking Chantix."
"Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure."
"The TGA will continue to monitor the situation," the spokeswoman said.
Both the TGA and Pfizer have said it is unknown whether Champix itself, nicotine deprivation or some other factor, could trigger the psychiatric reactions.
On December 3, 2007, The Bolton News in the United Kingdom reported 39-year-old Omer Jama, a popular television editor, slashed his wrists just weeks after beginning a course of pills to help him quit smoking. That report came two months after the first CBS 11 News investigation into Chantix.
In September, CBS 11 News uncovered thousands of adverse reactions to the drug reported to the FDA. And in late November,
CBS 11 News reported the FDA and its UK counterpart, the Medicines and Healthcare Regulatory Agency (MRHA), warned doctors to monitor patients on this anti-smoking medication for changes in behavior.
The Food and Drug Administration said it has received reports of mood disorders and erratic behavior among the estimated three million patients in the U.S. taking Chantix. The FDA said it is still gathering information about the drug, but said the changes have often been reported within days or weeks of people first taking the drug. The MHRA has received 839 reports of adverse reactions. Forty-six were linked to depression, with 16 claiming to have suffered suicidal thoughts.
In September, pharmaceutical giant Pfizer, which markets the drug, told CBS 11 News its analysis "does not suggest a causal relationship between Chantix and violent behavior." And in late November, a spokesman told CBS 11 News, "Quitting smoking, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness."
You can read the company's entire statement here.It was the
death of Dallas musician Carter Albrecht in September that launched the CBS 11 News investigation of Chantix. Albrecht took Chantix with alcohol and began banging on the door of his girlfriend's neighbor. The neighbor shot and killed Albrecht. His family and girlfriend, Ryann Rathbone, believe his erratic behavior was related to Chantix.
(© MMIX, CBS Broadcasting Inc. All Rights Reserved.)
Click to enlarge
Stumble It!
