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FDA Drug Safety Podcast: Ongoing safety review of Parkinson’s drug Mirapex (pramipexole) and possible risk of heart failure

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Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s topic: Ongoing safety review of Parkinson’s drug Mirapex, generic name pramipexole, and possible risk of heart failure

United States Public Health Service Commander Ray Ford, a pharmacist in the Division, will provide you with additional information about this Communication.

CDR Ford: On September 19, 2012, the FDA issued a Drug Safety Communication informing the public about a possible increased risk of heart failure with Mirapex, generic name pramipexole, a drug used to treat Parkinson’s disease and restless legs syndrome. Results of recent studies suggest a potential risk of heart failure that needs further review of available data.

FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with Mirapex than with placebo; however, these results were not statistically significant. FDA also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with Mirapex use. However, study limitations make it difficult to determine whether excess heart failure was related to Mirapex use or other influencing factors.

Because of study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex and will update the public when more information is available.

Health care professionals should continue to follow the recommendations in the drug label when prescribing Mirapex. Patients should continue to take their Mirapex as directed and should contact their health care professional if they have any questions or concerns.

At this time FDA recommends that Health Care Professionals be aware that:

  • FDA has not concluded that Mirapex increases the risk of heart failure. The Agency is continuing to review this safety concern and will update the public when more information is available.

  • The recommendations in the drug label should continue to be followed when prescribing Mirapex.

  • The benefits and potential risks of Mirapex should be discussed with your patients.

  • Patients should be counseled to seek medical attention if they experience symptoms of heart failure while taking Mirapex.

  • Adverse events involving Mirapex should be reported 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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