July 1 the Office of the Food and Drug Administration USA (Food and Drug Administration - FDA) anno

July 1 the Office of the Food and Drug Administration USA (Food and Drug Administration - FDA) announced that it has demanded from Pfizer and GlaxoSmithKline to include instruction on the use of drugs for the treatment of nicotine addiction Chantix / Chempiks (varenicline) and Zyban / Zyban (bupropion) information about the risk of serious mental disorders, including changes in behavior, depressed mood, aggression and suicidal thoughts.
This decision is based on a review of adverse reactions, which went into management, as well as the analysis of data from clinical studies and scientific literature, according to the FDA. According to the analysis of data conducted by management, some patients taking these drugs, noted in his unusual changes in behavior, dalay depression, thoughts of suicide or death. As noted by the FDA, in many cases, the problem appeared soon after initiation of treatment and disappeared dalay when treatment was discontinued.
The department also reported that such information concerning cases of mental disorders will be requested for all drugs bupropion. In addition, FDA will require that manufacturers have conducted dalay studies to determine how often serious neuropsychiatric symptoms occur in patients who have resorted to various methods of treatment of nicotine dependence.
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