Remicade / Infliximab
Remicade (infliximab), a drug manufactured by Johnson & Johnson subsidiary Centocor, is used to treat arthritis. Like Enbrel, another popular arthritis drug, Remicade has been associated with potentially deadly infections, including tuberculosis, histoplasmosis, listeriosis, and pneumocystosis. In addition to infection concerns, the FDA recently warned that Remicade use by patients suffering from congestive heart failure may be dangerous.
On August 15, 2001, Centocor announced that the company was adding a so-called "black box warning" to Remicade's label in order to better inform doctors and patients of the increased chance of developing tuberculosis while taking the drug. The announcement precedes a Food and Drug Administration (FDA) investigation into the safety of both Remicade and Enbrel.
A black box warning is the strongest available to drug manufacturers. Centocor recommends that patients undergo testing for tuberculosis before starting arthritis treatment with Remicade. In addition, the company claims that the drug has been associated with 84 cases of tuberculosis and at least 14 deaths.
In August 2004, the FDA and Centocor revised the WARNINGS and ADVERSE REACTIONS sections of the labeling for Remicade. Cases of leukopenia, neutropenia and pancytopenia, some with fatal outcome, and cases of CNS manifestation of systemic vasculitis, were described in patients receiving Remicade. The ADVERSE REACTIONS section was updated to include neutropenia, pericardial effusion and systemic and cutaneous vasculitis.
In October 2004, FDA and Centocor notified healthcare professionals of more revisions to the WARNINGS and ADVERSE REACTIONS sections of the prescribing information for Remicade. In controlled studies of all TNF-blocking agents, including Remicade, more cases of lymphoma have been observed among patients receiving the agents than among control group patients. Malignancies have also been observed in open-label, uncontrolled clinical studies at a rate several-fold higher than expected in the general population. Patients with Crohn's disease or rheumatoid arthritis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma. FDA has recommended a warning concerning malignancy be added to the labeling for all therapeutic agents that block TNF.
In December 2004, FDA and Centocor notified healthcare professionals of revisions to the WARNINGS, ADVERSE REACTIONS sections and PATIENT PACKAGE INSERT of the prescribing information for Remicade. Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, have been reported in postmarketing data in patients receiving Remicade. Autoimmune hepatitis has been diagnosed in some of these cases. Severe hepatic reactions occurred between two weeks to more than a year after initiation of Remicade. Some of these cases were fatal or necessitated liver transplantation.
See your doctor if you are suffering from Remicade side effects.
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