FDA Alerts

FDA Clears System to Reduce Stroke Risk during Stent and Angioplasty Procedures
The U.S. Food and Drug Administration today cleared for marketing the ENROUTE Transcarotid Neuroprotection System (ENROUTE TNS), for use during a minimally invasive procedure to restore normal blood flow to narrowed carotid arteries.
FDA Compares Risks of Pradaxa and Warfarin
FDA research has taken a closer look at the risks of two medications commonly used to lower the risk for stroke and blood clots.
FDA Approves Rx to Lower Heart Attack and Stroke Risk
The FDA has approved a medication to lower various cardiovascular risks in certain high-risk patients.
FDA Approves Eliquis for Atrial Fibrillation Patients
The US Food and Drug Administration today approved the anti-clotting drug Eliquis ( apixaban ), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.
Generic Plavix Approved
The U.S. Food and Drug Administration approved generic versions of the blood thinning drug Plavix ( clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.
FDA Drug Safety Communication: Pradaxa
The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa ( dabigatran etexilate mesylate ) capsules.
(UPDATE 12/15) FDA Announces New Safety Recommendations For High-Dose Simvastatin
The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose--80 milligram (mg)--has been associated with an elevated risk of muscle injury or myopathy , particularly during the first 12 months of use.
New FDA Approved Device for Safer Brain Bypass Surgery
The FDA has approved a device that helps surgeons perform brain surgery safely on high-risk patients who are in danger of having a stroke.The FDA-approved surgical kit enables neurosurgeons to reroute the blood flow around an aneurysm of patients at greater risk of stroke during standard bypass surgery.