Remicade receives black box warning from FDA

posted on:
May 20, 2009


The makers of Remicade, a biologic treatment for various inflammatory disorders involving the immune system, have updated information on the medication to include a Boxed Warning of an invasive fungal infection and a rare type of T-cell Lymphoma. Some of the infections and diseases that resulted from use of Remicade have been fatal.

More than one million people worldwide use Remicade for the treatment of inflammatory disorders such as plaque psoriasis, rheumadoid arthritis, psoriatic arthritis, Crohn’s disease in adults, pediatric Crohn’s disease, ulcerative colitis and ankylosing spondylitis.

The “Black Box Warning” was issued by the Food and Drug Administration (FDA) after reports of serious infections caused by viruses, fungi or bacteria that spread through the body, including tuberculosis (TB) and histoplasmosis. Postmarketing studies have shown cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma in patients treated with TNF blockers including Remicade. These cases have had a very aggressive disease course and have been fatal.

All reported Remicade cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. All of these patients had received treatment with azathioprine or 6-mercaptopurine, both immunosuppressant medications, along with Remicade at or prior to diagnosis.

Patients are advised to discuss with their doctor any potential benefits and risks with taking Remicade, and be monitored closely by their doctors for signs and symptoms of TB during treatment of Remicade.

Negative side effects should be reported to the FDA online at, or by phone at 1-800-FDA-1088.

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