Safety Alerts & Recalls

What does this mean?

It is important to avoid drawing too many conclusions from the results of a single study. As smoking is a major risk factor for heart disease events including heart attacks and strokes, it is important for you to work closely with your doctor to find an appropriate method to help you stop smoking. If you take Chantix, this alert is a good reminder to follow up with your doctor to review your progress with your stop-smoking program. You can also review your heart disease risk factors with your doctor and ask him or her to suggest ways that you may be able to control some of these risk factors.

If you experience new or worsening symptoms of heart disease, including shortness of breath or trouble breathing, new or worsening chest pain, or new or worse pain in legs when walking, please contact your healthcare provider as soon as possible.

Healthcare providers and patients are encouraged to report side effects related to the use of their medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Chantix: New Study Links Drug to Heart Problems

A study published this week in the Canadian Medical Association Journal linked the stop-smoking drug Chantix (varenicline) to an increase in the risk of a heart attack, stroke, and other serious heart related events for smokers without a history of heart disease compared with smokers who did not use the drug. This finding adds to previous warnings about Chanitx’s connection to heart related risks for people with a history of heart disease which prompted the FDA to issue a safety notice last month.

The FDA continues to evaluate the heart related safety of Chantix as new information becomes available. At this time the FDA has not issued any statements about this new study. The FDA is currently working with Pfizer, the manufacturer of Chantix, to conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials to help determine if Chantix poses heart risks. The FDA will update the public when additional information is available.

For more information, please visit: more information here

To read the last month's MediGuard Safety Alert for Chantix, please visit: more information here

Source: MediGuard CRT
Publication Date: 2011-07-07
Last Updated: 2011-07-07

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