FDA Alerts

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.
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 Approves Drug for Acute Coronary Syndromes
The U.S. Food and Drug Administration today approved the blood-thinning drug Brilinta ( ticagrelor ) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).
(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.
Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall
AUDIENCE: Emergency Medicine, Risk Manager ISSUE: Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR . AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient. BACKGROUND: AEDs are used on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing. RECOMMENDATION: Defibtech will provide customers with a fr...
Abacavir Update: Yes It's Still Safe, For Now
The FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. Since the announcement there has been conflicting information on the potential increased risk of heart attack.
The Warning is on the Label
The FDA is notifying the public that information on the cardiovascular risks (including heart attack) of the diabetes drug rosiglitazone has been added to the physician labeling and patient Medication Guide.