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Last Updated: May 5, 2009 - 12:58:27 PM |
THURSDAY May 22, 2008 (foodconsumer.org) -- The Food and Drug Administration has received more than 3,000 reports of serious side effects of Chantix, an anti-smoking pill, including suicidal attempts, loss of consciousness, heart trouble and aggression since the drug was approved in 2006, according to a study report.
Reporting of adverse effects of a drug was not mandatory, and therefore the real number of cases of serious side effects associated with use of Chantix, which is made by Pfizer Inc., may potentially bigger than the one released by the FDA.
The FDA has a system to take reports of adverse side effects of any drug that is approved and sold on the market. However, these reports per se do not prove that any side effect is actually caused by a drug although the possibility can not be excluded.
The study report by the nonprofit Institute for Safe Medication Practices and Wake Forest University urges U.S. regulators to tighten warnings on Chantix, which has been prescribed 3.5 million times in the U.S. since it was approved in 2006, Bloomberg reports.
On May 21, the Federal Aviation Administration banned the use of Chantix by pilots in response to the report, spokesman Les Dorr was cited as saying.
The FDA issued an alert on Feb., 1, 2008 to highlight important revisions to the WARNINGS and PRECAUTIONS section of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms such as changes in behavior, agitation, depression, attempted and completed suicides.
On May 16, the FDA approved changes in the product labeling to address the issues. It warned that those who are taking Chantix and experiencing agitation, depressed mood, or changes in behavior that are atypical should stop taking the drug and call their doctors right away.
But the study report says the warnings need to be modified to mean that the medication shouldn't be used while driving, flying airplanes or operating machinery because Chantix also known as varenicline may lead to unconsciousness, seizures and hallucinations.
Pfizer defended Chantix saying that the side effects are already disclosed on the drug’s label. "When you've got the nicotine withdrawal along with Chantix, it's just very difficult to tell what is causing it," Gretchen Dieck, Pfizer's senior vice president for safety and risk management was quoted by Reuters as saying.
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