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The FDA notified primary care providers and patients that an increased risk of muscle injury in patients taking the highest approved dose of Zocor (simvastatin) 80 mg exists compared to lower doses and possibly other drugs in the “statin” class. Background of Zocor (simvastatin) Zocor (simvastatin) is a cholesterol-lowering medication, sold as a single-ingredient generic [...]

Neurology and Cardiology healthcare personnel are informed by the FDA that clinical trial data suggest that patients taking Stalevo (carbidopa/levodopa and entacapone) may be at greater cardiovascular risk than patients taking carbidopa/levodopa (Sinemet). Background of Stalevo Stalevo and Sinemet are drugs considered as effective for the symptoms of Parkinson’s disease. Compared to treatment with carbidopa/levodopa [...]

New information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics) has been evaluated by the FDA. Results show that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of [...]

After completion of the evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod) the US FDA could not definitively conclude that Gilenya was related to any of the deaths. Nevertheless the agency remains concerned about the cardiovascular effects of Gilenya after the first dose. Background [...]