REMICADE LEGAL HELP CENTER - REMICADE LAWYER
Remicade (Infliximab) is manufactured by Centocor, Incorporated and is prescribed to improve physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to other medication. In November of 1999, the FDA approved Remicade (infliximab) to treat rheumatoid arthritis. The problem with Remicade is that it acts as an immune suppressant. This makes patients who take Remicade extremely vulnerable to opportunistic infections, including tuberculosis and sepsis.
Subsequent to FDA approval, Remicade (Infliximab) issued a Black Box Warning and the FDA notified health professionals that tuberculosis and other serious opportunistic infections, including histoplasmosis, listeriosis, and pneumocystosis, have been reported in both the clinical research and post-marking surveillance settings. Some of these infections have been fatal. Accordingly, Centocor added a BOXED WARNING to the labeling for the product, and the WARNINGS and ADVERSE REACTIONS sections of the product labeling were revised in October 2001.
Distressing results have also been identified when Remicade was used in patients with congestive heart failure. In a study of 101 patients, seven died.
Reports also suggest that infusion reactions with hives, difficulty in breathing, and low blood pressure may also happen. Some people have also experienced upper respiratory infections, headache, nausea, cough, sinusitis, and rash skins.
