After reviewing the results of the ROADMAP and ORIENT trials, the FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Benicar is not recommended as a treatment to delay or prevent protein in the urine ( microalbuminuria ) in diabetic patients. Patients should consult their healthcare professional if they have any questions or concerns about taking Benicar . Daiichi Sankyo , the makers of Benicar , have agreed to work with the FDA to perform additional ...

The U.S. Food and Drug Administration (FDA) is reviewing data from a clinical trial that was evaluating the effects of the antiarrhythmic drug Multaq ( dronedarone ) in patients with permanent atrial fibrillation.

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).

The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix ( varenicline ) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.

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.

The U.S. Food and Drug Administration (FDA) is informing the public about new information that is being assessed as part of their ongoing safety review of birth control pills that contain drospirenone . This review will further evaluate the risk of blood clots in women who use these products.

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...

The FDA has approved a new drug combination to treat two rare disorders that cause blood vessels to become inflamed. 

The U.S. Food and Drug Administration (FDA) has approved the cPAX Aneurysm Treatment System for surgery on brain aneurysms that are difficult to manage because of their size and shape.

The U.S. Food and Drug Administration approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery.