Safety Problems with Varenicline (Chantix)
Filed Under (Anti Viral) by David on 06-02-2010
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An Early Communication has been issued about varenicline (Chantix, Pfizer), which is approved as an aid to smoking cessation drug. This notice does not mean that the FDA perceives a causal relationship between the drug and the emerging safety problem.
Pfizer recently submitted reports to the agency describing suicidal thoughts in association with the drug. In the wake of a case report citing erratic behavior in a patient who had used varenicline, the FDA has also asked the company for any information on additional cases that might be similar in patients who have taken the drug.
After the FDA’s Center for Drug Evaluation and Research completes its analysis, the FDA will communicate its recommendations to the public. In the meantime, the FDA recommends that health care providers monitor patients taking varenicline for behavior and mood changes. The FDA also advises that, because of reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix affects them.
(Source: FDA, November 21, 2007.)