Remicade

Patients taking Remicade for rheumatoid arthritis suffered a type of cancer, lymphoma, at three times the rate of the general public, manufacturer Centocor warned. Centocor, a subsidiary of Johnson & Johnson, said the lymphoma incidence rate was six times higher among all patients who took the monoclonal antibody in completed clinical trials.

The FDA has been told of 580 adverse reaction reports among 509,000 worldwide patients, said Craig Buchholz, a Centocor spokesman. Forty-four reports were most worrisome because they involved significant blood disorders. At least 12 patients taking Remicade in combination with other drugs died worldwide.

The company's Aug. 11 warning letter to doctors said patients receiving Remicade suffered reductions in their red and white blood cell, granulocyte and platelet counts, leaving them more vulnerable to abnormal bleeding and infections. In rare instances, patients suffered central nervous system disorders, including confusing immune system responses that swelled, and then decayed, blood vessels.

Centocor warned physicians to exercise caution when treating patients with histories of significant blood abnormalities with Remicade. Patients with persistent fevers should seek immediate medical attention.

Remicade (Infliximab), an immune-suppressing drug used to treat rheumatoid arthritis and Crohn's disease, is reported to be responsible for 70 reported cases of tuberculosis (TB) among US patients. The cases, at least four of which were fatal, were reported to the Food and Drug Administration between 1998 and May of this year. Researchers who reviewed the cases say that the immune-system protein infliximab suppresses called tumor necrosis factor alpha (TNF-alpha) appears to be key in controlling TB infection.

Around 150,000 people worldwide have received infliximab infusions since the drug's approval in 1998. In August, Malvern, Pennsylvania-based Centocor, which markets infliximab as Remicade, announced it was changing the drug's prescribing information to address the TB concerns. The revised labeling states that patients should be tested and treated for inactive, or latent, TB prior to infliximab therapy. Latent TB refers to a chronic, but symptom less and noncontiguous, infection. Such TB infections are prevalent throughout the world because in most people, the immune system is able to suppress TB bacteria. Up to 15 million Americans are estimated to have latent TB infections.

When the immune system is suppressed as it is in patients on infliximab latent TB can become active. Active TB usually attacks the lungs, causing symptoms such as a severe cough, chest pain and weight loss. It is spread through the air from person to person.