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FDA Drug Safety Podcast: Safety review update of Chantix (varenicline) and risk of cardiovascular adverse events

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Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s Topic: Safety review update of Chantix, active ingredient varenicline, and risk of cardiovascular adverse events

US Public Health Service pharmacist Lieutenant Commander Beth Carr will provide you with additional information about this communication.

LCDR Carr: On December, 12, 2012, the FDA issued a Drug Safety Communication informing the public about the results of a large, combined analysis of clinical trials that compared patients who received the smoking cessation drug Chantix to patients who received a placebo. FDA required the manufacturer of Chantix to conduct the meta-analysis to further evaluate the cardiovascular safety of the drug, and believes it is important to let health care professionals and patients know about the results of this study. FDA first notified the public about a possible increased risk of cardiovascular adverse events with Chantix in its June 2011 Drug Safety Communication.

A higher occurrence of major adverse cardiovascular events were observed in patients using Chantix compared to placebo. These major adverse cardiovascular events were defined as a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke. These events were uncommon in both the Chantix and placebo groups, and the increased risk was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to the drug or due to chance. However, the data were analyzed many different ways and consistently showed a higher occurrence of events in patients using Chantix, which makes it seem more likely that it is related to the drug and not purely a chance finding.

The meta-analysis findings of cardiovascular risk are similar to the findings in the smoking cessation clinical trial of patients with stable cardiovascular disease that was described in FDA’s June 2011 Communication. The Warnings and Precautions section of the Chantix label has been updated to include the results of the meta-analysis.

Health care professionals are advised to weigh the risks of Chantix against the benefits of its use. It is important to note that smoking is a major risk factor for cardiovascular disease, and Chantix is effective in helping patients to quit smoking and abstain from it for as long as one year. The health benefits of quitting smoking are immediate and substantial.

Patients taking Chantix should contact their health care professional if they experience new or worsening symptoms of cardiovascular disease, such as chest pain, shortness of breath, calf pain when walking, or sudden onset of weakness, numbness, or difficulty speaking. Patients should also contact their health care professional if they have any questions or concerns about Chantix.

At this time FDA recommends thatHealth Care Professionals be aware of the following:

  • Smoking is an independent and major risk factor for cardiovascular disease, and Chantix is effective in helping patients quit smoking. The health benefits of quitting smoking are immediate and substantial.
  • Weigh the risks of Chantix against the benefits of its use.
  • Counsel patients to seek medical attention if they experience new or worsening symptoms of cardiovascular disease while taking Chantix.
  • Encourage patients to read the Medication Guide they receive along with their Chantix prescription.
  • Report adverse events involving Chantix to the FDA MedWatch program at www.fda.gov/medwatch

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication, including the complete Data Summary, can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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