Remicade: New FDA & Centocor Warning

On August 11, Centocor issued an "Important Drug Warning" to healthcare professionals regarding possible adverse reactions for Remicade® (infliximab). Remicade, a TNF-blocker, is sometimes prescribed off-label to those with Ankylosing Spondylitis, and is currently under FDA review for full approval for use in treating AS.

The letter states that, "hematologic and neurologic events" have occurred in some patients using Remicade. The hematologic (or blood related) effects include:

• leukopenia: An abnormal reduction in the number of leukocytes (white blood cells).



• neutropenia: An abnormal decrease in the number of neutrophils, a type of white blood cell.



• thrombocytopenia: A decrease in the number of platelets in the blood that may result in easy bruising and excessive bleeding from wounds or bleeding in mucous membranes and other tissues.



• pancytopenia: An abnormal deficiency in all blood cells (red blood cells and white blood cells and platelets); usually associated with bone marrow tumor or with aplastic anemia.

The FDA has stated that some of these adverse reactions have been serious enough to prove fatal.

The neurologic (or nervous system related) events include:

• CNS manifestation of systemic vasculitis: Swelling of the blood vessels in the brain.

The letter from Centocor states that Remicade treatment should be discontinued if "significant central nervous system adverse reactions" should develop.