The U.S. Food and Drug Administration (FDA) is removing the warning related to liver injury from the boxed warning of the Letairis ( ambrisentan ) tablet label.

The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa ( dabigatran etexilate mesylate ) capsules.

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 informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with Revlimid ( lenalidomide ) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review. At this time, FDA recommends that patients continue their Revlimid treatment as prescribed by their...

The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as h epatosplenic T-Cell lymphoma or HSTCL ), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor ( TNF ) blockers, as well as with azathioprine , and/or mercaptopurine . Crohn's disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, wei...

The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy ( PML ), a rare but serious brain infection, associated with use of Tysabri ( natalizumab ) for the treatment of multiple sclerosis (MS) and Crohn's disease.

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.