FDA warns of Zyban, Champix depressive side-effects
Last Updated: Thursday, July 2, 2009 | 12:41 PM ET Comments97Recommend38The Associated Press
The U.S. Food and Drug Administration will require two smoking-cessation drugs, Champix and Zyban, to carry the agency's strongest safety warning over side-effects including depression and suicidal thoughts.
The new requirement, announced Wednesday, "will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs," the FDA said in a statement on its website.
Despite the new, stricter warnings, the FDA said consumers and doctors still have to weigh the benefit versus the risks when taking the drug.
“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research.
The antidepressant Wellbutrin, which has the same active ingredient as GlaxoSmithKline PLC's Zyban, already carries such a warning.
The FDA said it is also requiring an additional study on Champix and Zyban to determine the extent of the side-effects. Pfizer Inc., which makes Champix, said it is still discussing the potential study design with the FDA.
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4 comments:
Chantix has shown success rate in cessation of the smoking habit. Many people on chantix have experienced side-effects like nauseous feeling, headaches, unpleasant dreams, lunacy, manic behaviour, bipolarity, delirium or schizophrenia. Also fatal accidents and suicides is informed. So FDA has issued black box warnings on chantix and zyban cautioning that doctors should mitigate the use of the drug by adopting a far observant attitude and supervise the patients.
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any reecent news regardinf chantix?
thought i heard something on the tv.
thanks
Champix adopts a unique mechanism to fight nicotine addiction. Only Champix targets the receptors in the brain responsible for nicotine addiction. Its active ingredient Varenicline acts as a nicotine receptor antagonist. Champix Varenicline attaches itself to the nicotine receptors in the brain and stimulates them. Thus Champix imitates the effect of nicotine and dupes the brain into thinking that it has received its dose of nicotine.
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