FDA News & Recalls News

power morcellation

FDA Pushes for Warning on Power Morcellators, Informed Consent

Members of a specially formed Food and Drug Administration panel say there is not enough evidence to prove using power morcellators to remove uterine fibroids does not increase the risk of spreading undetected cancer – a risk that may be more common than previously thought. During a recent two-day meeting, the FDA health advisors concluded […]

Jul 16, 2014

The FDA is requiring blood clot warnings on testosterone packages.

FDA Requires Testosterone Drugmakers to Add Blood Clot Warning

The U.S. Food and Drug Administration (FDA) is requiring manufacturers of testosterone replacement drugs to include warnings about the increased risk of blood clots that may develop and cause conditions such as deep vein thrombosis and pulmonary embolism. Product labels already warn of possible clots forming because of a condition called polycythemia, which causes an […]

Jun 23, 2014

red blood cells

FDA, Experts Discuss Risks of Newer Blood Thinners

Anticoagulants like warfarin and Pradaxa are considered effective treatments for preventing blood clots in people with heart and blood vessel diseases. But the drugs can also cause excessive bleeding. Balancing the benefits of anticoagulants against excessive bleeding risks is a challenge for medical researchers and clinicians. That’s why the Food and Drug Administration (FDA) and […]

May 19, 2014

Generic prescription drugs

Petition Calls on FDA to Hold Makers of Generic Drugs Accountable

Gabriel Drapos was a freshman at Harvard when he was diagnosed with ulcerative colitis and had to have his large intestine removed. A generic form of the acne medication Accutane was to blame. Karen Bartlett took the generic pain pill sulindac for shoulder pain. Within weeks, her skin began peeling off in clumps. Her lungs […]

Apr 30, 2014

FDA warning

Inspection Triggers FDA Warning for Mesh Manufacturer

The U.S. Food and Drug Administration (FDA) issued a warning letter to Endo International PLC following an inspection of the pharmaceutical company’s facility in Minnetonka, Minn. According to the FDA, Endo violated three federal regulations governing how it manufactures some of its urological devices. Endo’s Minnesota facility is run by its subsidiary, American Medical Systems […]

Apr 23, 2014

Injection Needle

FDA Approves Aveed Testosterone Product, with Restrictions

The U.S. Food and Drug Administration (FDA) this month approved the testosterone replacement therapy (TRT) drug Aveed, despite recent studies that show these types of medications significantly increase the risk of heart attacks in many men. FDA officials rejected Aveed three times prior to granting final approval because they needed more information on the drug’s […]

Mar 13, 2014