FDA Alerts

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.
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.
New Drug to Relieve the Pressure
The U.S. Food and Drug Administration (FDA) today approved Edarbi tablets ( azilsartan medoxomil ) to treat high blood pressure (hypertension) in adults.
Stop the Bleeding
The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
Dangerous Drug for Pregnant Women
The FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention of, or for prolonged (beyond 48-72 hours) treatment of preterm labor.
Recall of Surgical Medical Device
Components of the Arstasis One Access System, a device that provides access into the vascular system and can stop an artery from bleeding, may fracture and/or separate during use, which may result in patient harm.
Your Heart Won't Burst Through Your Chest
The U.S. Food and Drug Administration (FDA) today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.
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.
Same Drug, Different Recall
Godi International, Corp., located in South Florida is announcing a recall of Fruta Planta weight loss dietary supplements because the products contain sibutramine , an undeclared drug ingredient.
UPDATE: AngioScore Balloon Catheter Recall
Information has been updated on AngioScore Incorporated's voluntary recall of their balloon catheters, due to bond failures that could result in death.