FDA Approves Humira to Treat Ulcerative Colitis
The U.S. Food and Drug Administration today expanded the approved use of Humira ( adalimumab ) to include treatment of moderate-to-severe ulcerative colitis in adults.
Abbott Drug Gets Positive Review in Ulcerative Colitis
Abbott announced that the European Committee for Medicinal Products for Human Use ( CHMP ) has issued a positive opinion for Humira ( adalimumab ) in adults with moderate to severely active ulcerative colitis ( UC ) who have not responded to, cannot tolerate or have medical contraindications to conventional therapies.
FDA Focus on TNF Blockers
A class of drugs is now under suspicion of causing cancer in children, adolescents and young adults under the age of 30. These are called Tumor Necrosis Factor (TNF) blockers, and the U.S. Food and Drug Administration (FDA) recently released an update regarding its ongoing safety review of these drugs.
FDA Drug Safety Communication: TNF blockers
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...