The FDA revealed its intention to demand two nicotine-replacement therapies Chantix and Zyban, to place the agency’s toughest warning because of severe side effects related to their consumption among which is strongest depression, aggression and inclination to suicide.
The latest request, defined as a “Black Box” warning, is grounded on the feedback from people who were taking these drugs and noticed uncommon alterations in behavior, feeling sad, stressed and depressed or even coming into thought about committing a suicide. Wellbutrin, a well-known antidepressant medication that has identical active component as Zyban produced by GlaxoSmithKline PLC’s has already been placing similar warning for some time.
The Food and Drug Administration has as well demanded an additional thorough examination on Chantix and Zyban in order to establish the dimension of the adverse effects of these medications. Pfizer Inc., the manufacturer of Chantix, admitted it is so far negotiating the design of forthcoming test with the FDA officials. The research could comprise examinees with and without psychiatric disorders to estimate the actual case rate of psychological adverse effects, Pfizer spokesperson stated.
Pfizer had already changed its warnings after the initiation of an FDA examination into the possible adverse effects two years ago. The latter examination was triggered by records of more than 35 suicides and around 400 cases of suicidal thoughts or behavior while being on Chantix medication.
Last year, the FDA spokesperson stated that the relation between Chantix and severe mental disorders was highly probable, despite the drug’ producer had already modified warning labels n order to alert consumers about potential adverse effects. However, although the FDA has demanded more precise and tough warnings, the agency still admitted the doctors and patients have to balance the advantages against the jeopardy when administering the medication.
Dr. Jeanette Maki, vice director of the FDA’s Department for Drug Examination said that the risk of severe side effect while being on those drugs should be compared with the essential benefits for health after giving up smoking.
In 2008, the FDA as well started investigating the patient reports concerning faints, blackouts, and other non-psychiatric adverse effects while being on Chantix. Two months later, The Civil Aeronautics Administration prohibited consumption of Chantix by pilots, flight attendants and air traffic officers. The Chantix’ warning label as well says that adverse effects include temporary visual impairment and advices patients to avoid driving vehicles.
The FDA has approved Chantix in 2006. Pfizer, the maker of Chantix, collected $846 million in revenues last year, what was a 4 percent reduction in comparison with 2007 due to the growth of concerns related to potential severe side effects.
Pfizer declared it revised warning label warnings after reaching agreement with the FDA and is spreading the updated information among physicians and consumers.
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