FDA Approves UC Drug - Consumer Justice Foundation

FDA Approves UC Drug

Written by Faith Anderson on September 27, 2011
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The UC Drug, Remicade

Remicade, manufactured by Janssen Biotech Inc. of Malvern, Pennsylvania, works by reducing the signs and symptoms of UC, and inducing and maintaining clinical remission in these patients. Remicade belongs to a class of drugs called tumor necrosis factor (TNF) blockers, which suppress the immune system by blocking the activity of TNF, a substance in the body that can cause inflammation and lead to autoimmune diseases. In addition to being approved for UC, Remicade is approved for the treatment of other autoimmune diseases, including Crohn’s disease in adults and children six years and older, rheumatoid arthritis, ankylosing spondylitis (arthritis affecting the joints in the pelvis and spine), plaque psoriasis in adults, and psoriatic arthritis (joint pain associated with psoriasis).

Serious Side Effect Risks Associated with Remicade

“With the approval of Remicade, children with moderately to severely active ulcerative colitis who have not had an adequate response to conventional treatment now have an FDA-approved treatment option,” said Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “However, there are serious risks associated with its use. Patients and their families should always discuss with their physician the risks and benefits of using a medication before deciding to start treatment.”

Remicade carries a Boxed Warning for the risk of serious infections and cancer. Increased risks of infections include tuberculosis and infections caused by fungi, bacteria and viruses. According to the FDA, there have been cases of unusual cancers reported in adolescent and young adult patients using TNF-blocking agents like Remicade, including a rare and fatal type of cancer called Hepatosplenic T-cell Lymphoma. According to the FDA, children should have all of their vaccines brought up to date before beginning Remicade treatment, and should not receive live vaccines while taking the UC medication. The most common side effects associated with Remicade are upper respiratory infections, worsening of ulcerative colitis, headache, and infusion-related reactions.

Posted Under: FDA - Food and Drug Administration
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