Stop-Smoking Drug Leads Some People to Madness
Varenicline (marketed as Chantix) is a nicotine receptor partial agonist. [same receptor for dopamine]
Agonist - A drug or other chemical that can combine with a receptor site on a cell to produce a physiologic reaction typical of a naturally occurring substance.
FDA Issues Public Health Advisory on Chantix (Varenicline)
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html
On February 1, the Food and Drug Administration warned that Chantix, which had fourth-quarter sales of $280 million (up from $68 million a year ago), could cause serious psychiatric problems.
"When they tested the drug, the sample they chose simply isn't representative of the people they're targeting," says Dr. Daniel Seidman, the director of Smoking Cessation Services at Columbia University Medical Center. "By excluding drinkers, you're artificially inflating your results, potentially. I run a clinic, and two out of three [smokers] I see have a psychiatric or mood problem. None of these people would have been part of the original trials."
The term suicidal ideation looks pretty dead on the page, and if you were ever to experience such a symptom, it's unlikely you'd pick up on it right away: "Here comes that damned suicidal ideation again. I had better call my physician." For me, self-destructive fantasies slowly began cropping up as cartoonish flights of fantasy-nagging, almost imperceptible chatter that became a little more concrete and domineering with every passing day.
"It felt as if the essential barrier between reality and my imagination had eroded."
http://nymag.com/news/features/43892/
Common side effect associated with Chanitx are nausea, sleep disturbance, constipation and vomiting.
While most side effects are mild, there have been growing reports of more serious side effects. In fact, in the fourth quarter of 2007 varenicline accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period. By comparison the FDA received a median of 5 reports of serious injury for 769 different drugs in the fourth quarter. Only 35 drugs accounted for 100 or more reports.
Serious side effects included:
- depression, including suicidal thoughts and tendencies
- aggressive behavior
- severe allergic reactions and Stevens-Johnson Syndrome (SJS)
- hepatitis
- liver failure
- diabetes
http://www.beasleyallen.com/focus/Chantix/
Side Effects
In November 2007, the FDA announced it had received post-marketing reports that patients using Chantix for smoking cessation had experienced several serious symptoms, including suicidal ideation and occasional suicidal behavior, erratic behavior, and drowsiness. On February 1, 2008 the FDA issued an Alert to further clarify its findings, noting that "it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms." It is unknown whether the psychiatric symptoms are related to the drug or to nicotine withdrawal symptoms, although not all patients had stopped smoking. The FDA is aware of the highly-publicized case of Carter Albrecht who, in an apparent state of delirium, was shot to death by his neighbour after hitting his girlfriend and then trying to forcibly enter the neighbor's house.[6] Although in this case the delirium appeared to be caused by taking varenicline with a high dose of alcohol, the FDA asked Pfizer for additional cases that might be similar. It also recommended that health care professionals and patients watch for behavioral and mood changes.[7]
On Thursday, May 22, 2008, The New York Times reported that the U.S. Federal Aviation Administration (F.A.A.) had announced the day before a ban on the use of Chantix (varenicline tartrate) for both pilots and air traffic controllers, due to concerns with possible adverse neuropsychiatric effects which could be detrimental to public safety.[8]
On Sunday, May 25, 2008, The Los Angeles Times reported that over 2 dozen traffic accidents had been linked to Chantix and reported to the FDA. Warnings had previously been issued by Pfizer regarding the risks of Chantix while driving, however these warnings have largely been ignored by doctors and patients.[9]
On Tuesday, June 17, 2008, The Washington Times reported on its Front Page that the United States Department of Veterans Affairs was testing Chantix on war veterans with Post Traumatic Stress Disorder without properly warning them of the side effects, and that in one case a veteran was almost killed when he had a psychotic episode and threatened police officers.[10]
http://en.wikipedia.org/wiki/Chantix