FDA: Two popular ‘stop-smoking’ drugs to carry “black box” warning

FDA: Two popular ‘stop-smoking’ drugs to carry “black box” warning

According to a statement by the U. S. Food and Drug Administration (FDA), the packaging of two popular 'stop-smoking' drugs - varenicline (Chantix) and buproprion
(Zyban, Wellbutrin and generics) - will carry "black box" warning, because of their supposed risk related to serious neuron-psychiatric symptoms.

The FDA decision about the warning labels on Chantix and Zyban comes after the agency's adverse event reporting system noted incidents of wacky behavior linked to the use of the drugs - the changes in behavior included depressed mood, agitation, hostility and suicidal thoughts!

The report calls to notice the fact that during the course of the marketing history of these smoking-cessation drugs, 98 suicides and 188 attempted suicides have been linked to varenicline use; while and 14 suicides and 17 attempted suicides to buproprion use.

Talking about FDA's decision about the 'stop-smoking' drugs, Robert J. Temple - Director of the FDA's office of medical policy - said: "We want people to use these drugs carefully and pay attention. Stopping smoking is a goal we all want to work toward. We don't want to scare people off these drugs - we just want them carefully monitored."

The FDA will ask the Chantix maker, Pfizer, and the Zyban maker, GlaxoSmithKline, to conduct clinical trials, with smokers with underlying psychiatric disorders, for assessing whether these two drugs actually bring about behavioral changes, including suicidal tendencies.

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