International Herald Tribune
European Union officials investigate safety of Pfizer's anti-smoking drug
The Associated Press
Friday, December 14, 2007
LONDON: Following reports of depression and suicide in patients taking the anti-smoking drug Champix, the European Union's medicine authority has begun investigating its safety.
On Friday, the European Medicines Agency asked Champix's maker, Pfizer Inc., to submit more information about the incidences of depression and suicide in patients taking the drug.
"Based on a preliminary review of patient reports, our committee concluded this could signal a problem," said Monika Benstetter, a spokeswoman for the EU agency, which authorizes medicines for use in the 27-nation bloc.
As part of its routine drug surveillance, the agency reviewed cases of Champix patients who had suicidal thoughts or attempted suicide from July, October and November.
Champix was licensed for sale as a smoking cessation aid in the European Union last September. The drug works by binding to nicotine receptors in the brain, as well as by reducing the symptoms of withdrawal. Champix is available as tablets, and must be taken under medical supervision.
At a meeting this month, the EU agency concluded that "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."
Pfizer said that it is working closely with the EU agency to review cases of depression and suicidal thoughts in patients taking Champix. "There is no scientific evidence establishing a causal relationship between Champix and these reported events," a company statement said.
Experts acknowledged that establishing a causal relationship between taking Champix and depression or suicide would be difficult. American regulators have said that nicotine withdrawal could aggravate existing mental problems.
But not all experts agreed. "Coming off smoking may make people depressed, but there's little evidence for the re-emergence of major psychiatric illness," said Dr. Peter Hajek, director of the Tobacco Dependence Research Unit at Queen Mary University Hospital in London.
The EU agency's decision follows reports from the United States last month, where the drug is sold as Chantix, that at least one patient died while taking it.
Family members of Dallas musician Carter Albrecht said the Pfizer drug may have caused the rage that ultimately led to his death. 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 Albrecht's blood alcohol was three times the legal limit.
The U.S. Food and Drug Administration said it asked Pfizer for information on additional cases that might be similar.
In Europe, the EU agency has asked Pfizer to submit modified product information next week that warns doctors and patients about the potential for depression or suicide in patients taking Champix. The drug's current product information does not include any warnings about suicidal thoughts. Further action could be taken if warranted, Benstetter said.
Hajek said that more information was needed before a real link between Champix and depression or suicide could be confirmed. "So far, these are just anecdotal reports," Hajek said. "We need to see a more established pattern from more data."
Chantix: New Labeling Warns of Suicide
Washington, DC: Just one day prior to the revelation that yet another smoking cessation patient has died at the hands of Pfizer's anti-smoking drug, the manufacturer unveiled the latest warning pertaining to the potential for suicidal thoughts.
Before last Friday, Chantix product information only hinted at dire behaviors in less-prominent sections of product literature. However, following a litany of complaints that have flooded into the office of the US Food and Drug Administration (FDA), together with an ongoing review of the drug's ultimate safety, Pfizer on January 18th updated the Chantix product labeling to reflect more serious concerns.
Depressed mood, agitation, suicidal thinking and suicidal behavior have been the reality for many users of Chantix, and its European counterpart Champix. As of now, the Chantix label specifically lists these concerns and asks doctors and health professionals to monitor for these behaviors.
Ironically, the day after the new, intensified product labeling for Chantix was announced, came word of yet another suicide attributed to Champix, which is marketed in the United Kingdom and is not regulated by the FDA.
Smoking and SuicideIn this latest suicide, a 36-year-old husband and father of two from Yorkshire hanged himself back in November, shortly after completing a 13-week Champix program. His death comes a month after a 39-year-old man took his own life—again in the UK, and again as a result of using Champix.
European regulators have ordered improved warnings on the product, in view of its link to depression.
According to the Medicines and Healthcare products Regulatory Agency (MHRA), one individual had taken his own life while on the medication, while two others had attempted suicide and upwards of 60 adverse reactions consistent with suicidal thoughts had been reported.
Wayne Marshall was a welder and life-long smoker who had tried everything to stem his 20-smoke-a-day habit, according to his widow Emma. He had been excited about the drug's promise when prescribed to him in August, but according to his wife Wayne quickly went downhill. She indicates in published reports that he had cut himself off from family and friends, and had signed himself off work about a week before he died. However, she said, there were no outward signs that he was contemplating an end to his life.
Still, the changes to his personality were staggering. Always one to have a large circle of friends, to go out with the boys and cheer on the local football team, to find her husband sitting on the stoop sobbing uncontrollably was surreal. And even though he had taken up smoking again after finishing the 13-week Champix program, he appeared upbeat. He was talking with his young wife about Christmas with his two children from a previous marriage.
All seemed well, until November.
Chantix, and its British counterpart burst onto the market last year with much promise. It is the only smoking cessation drug of its kind that specifically targets those receptors in the brain that respond to nicotine. Chantix attaches itself to those receptors and prevents nicotine from reaching them, thereby preventing the receptors from releasing a round of pleasureful, but short-lived dopamine. The theory is that unlike cessation programs that serve to gradually withdraw from nicotine, Chantix eliminates the pleasure principal entirely.
However, the language on Pfizer's own Chantix web site does little to instill confidence, repeatedly deferring to the word 'believe' when describing how the program allegedly works.
Chantix is just the latest in a serious of drugs that have been the center of concern over behavioral issues. Just this week it was revealed that the FDA has been undertaking an analysis of various anti-depressants over concern about dynamic changes in mood, emotion and behaviors—changes which can be present in divergent drug classes.
It has been learned that the FDA has forwarded communiqués to all drug manufacturers, with regard to a testing protocol for suicide and other dire adverse effects.
Chantix has had a banner year, in its first full year of availability. The drug is used by more than five million patients, with sales of $603 million through the third quarter of 2007.
It will be interesting to see how Chantix holds up under this latest scrutiny with regard to safety.