19 February 2008

Chantix Label Updated

Chantix Label UpdatedCHANTIX, a selective nicotinic acetylcholine receptor partial agonist, is the first non-nicotine prescription treatment for smoking cessation in almost a decade. It has been prescribed to more than 4 million patients in the United States since approval. It helps people give up smoking in two ways: it gives the same feeling of satisfaction as nicotine and it blocks the effect of nicotine on the brain. The first effect lessens the symptoms of withdrawal, while the second stops nicotine from triggering the brain's reward center.

Based upon post-marketing reports first reflected in a November 2007 labeling update, Pfizer today (On January 18, 2008) updated the CHANTIX label in the U.S. to include a warning that patients who are attempting to quit smoking with CHANTIX should be observed for serious neuropsychiatry symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.

In the controlled clinical trial program of more than 5,000 patients treated with CHANTIX, changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior occurred at a rate comparable to placebo-treated patients. There were no suicides attributed to CHANTIX in clinical trials. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the controlled clinical trial program.

The FDA began investigating reports of erratic behavior in Chantix users in November 2007. While a causal relationship has not been found between the drug and abnormal behavior, in some cases, an association cannot be excluded, according to Pfizer.

Since its approval by the FDA in May 2006, Chantix has been prescribed to over 4 million smokers trying to kick the habit. Chantix has helped many people to beat their addiction to nicotine in a comfortable way, but maybe this drug isn't suitable for everyone. Visit your doctor to get help in deciding whether this smoking cessation drug might be right for you.

If you are thinking of quitting smoking, you will find many people ready with advice. US government's website advises that you prepare to quit with S - T - A - R - T, which stands for:

S - Set a date.
T - Tell people: friends, family, work colleagues.
A - Anticipate and plan for the challenges you will face while quitting.
R - Remove temptation: clear your home, car and workspace of tobacco.
T - Talk to your doctor and get good, well informed support.

Chantix: Patient Stories

Stephen M. says that it only took eight days after starting his prescription before he had a serious reaction to Chantix. He notes that the day he doubled his dosage he had a nervous breakdown. Following that nervous breakdown, he suffered from panic attacks, shaking hands, a sense of hopelessness and thoughts of committing suicide. He was taken to the ER because of the severity of his panic attacks and required time off work to recover.

Chris started taking Chantix around the beginning of April last year. He says that the only side effects that were really explained to him were the nausea and strange dreams. Within a month of taking Chantix, Chris began to change. "I started worrying about everything, became really paranoid. I have a small company and I was running the guys ragged, trying to get two years' worth of stuff done in six months."

Brian W. admits that he dealt with depression before he started taking the smoking cessation drug Chantix. However, he says that after he started taking Chantix, his depression became a lot worse, to the point that he threatened to divorce his wife and tried to kill himself. Brian says that he started taking Chantix four months ago and within one to two months started to feel more depressed. Approximately two months ago, he tried to commit suicide by taking sleeping pills, but managed to stop himself in time. He says that to some degree, he was not in control of his thoughts when he took Chantix.

Sandra had been smoking for 10 years and had tried every method available to quit when she was told about Chantix. Hearing that people had some success on the drug, she decided to give it a shot. She took her first Chantix dose on October 21, 2007 and since then has experienced a wide range of side effects, including nightmares and suicidal ideation.