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FDA places pramipexole under safety review

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Dallas Law Blog 2012 September FDA places pramipexole under safety review
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FDA places pramipexole under safety review

Posted By Dean Gresham || 28-Sep-2012

WebMD (9/20, Warner) reports that the FDA is "investigating a possible risk of heart failure linked to Mirapex [pramipexole], a drug used to treat Parkinson's disease and restless legs syndrome." However, the FDA's safety alert "stops short of an official warning announcement for the drug." Agency officials "say recent studies suggest a potential raised risk of heart failure with the use of Mirapex, but further review of research is needed." The FDA says it is "working with Mirapex's manufacturer to clarify the risk of heart failure and will update the public when more information is available." Meanwhile, agency officials "say people taking Mirapex should continue to take the drug as prescribed and contact their health care provider with any questions or concerns."

Categories: Personal Injury, Pharmaceutical / Medical Device, Wrongful Death

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