Long-Term Side Effects of Remicade

Remicade (infliximab) is an injectible TNF-alpha inhibitor used to relieve the symptoms of certain autoimmune disorders, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriasis and psoriatic arthritis. TNF-alpha inhibitors act by reducing the pro-inflammatory signal cascade that causes many of the symptoms of autoimmune diseases; although they have no effect on the disease itself. Recently, significant long-term side effects of Remicade have been identified; it is good to be aware of these risks before taking this medication.

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Remicade has long been associated with an increased risk of developing cancer in adult patients with chronic obstructive pulmonary disease or psoriasis. In August 2009, the FDA issued new labeling requirements for drug companies to warn patients of the increased incidence of leukemia and lymphoma in children and young adults treated with Remicade. Between 1998 and April 2008, approximately 30 cases describing the development of cancer in patients under 18 treated with Remicade were submitted to the FDA’s Adverse Events Reporting System. Fifty percent were lymphomas, including a rare, aggressive T-cell lymphoma of the liver and spleen observed in Crohn’s disease patients who were also treated with Imuran (azathioprine) or Purinethol (6-mercaptopurine).

Drug-Induced Lupus

In some individuals, long-term use of Remicade has been associated with drug-induced lupus. In a November 2009 report published in the Mayo Clinic Proceedings, researchers recounted their clinical experience with 14 patients who developed this complication after an average treatment duration of 16.2 months 1. The most common symptoms were joint pain, butterfly shaped rash over the cheeks and face, disc-shaped rash elsewhere on the body, extreme sun sensitivity and mouth ulcers. In all patients, symptoms resolved within three months of drug discontinuation. About 80 percent of patients were subsequently switched to a different TNF-alpha inhibitor without recurrence of symptoms.

Liver Injury

Some patients on Remicade develop liver damage. The risk of hepatotoxicity is increased with prolonged use, in patients who are also taking other medications and in patients who have other risk factors for liver disease such as a history of alcohol abuse. Signs of liver damage include jaundice (yellowing of the eyes and skin), dark brown urine, right sided abdominal pain, extreme fatigue and fever. In most cases, liver damage will be detected on routine blood tests before you experience symptoms. A 2008 study in the Journal of Clinical Gastroenterology found that for almost 80 percent of patients with evidence of liver damage on laboratory tests, damage resolved after a reduction in the dose of Remicade.

Blood Abnormalities

In very rare cases, Remicade may cause the bone marrow to stop producing red blood cells, white cells or platelets. Symptoms of blood and platelet abnormalities include fatigue, pallor, prolonged bleeding time and abnormal bruising. Neutopenia, or the lack of a certain kind of white blood cells, is evidenced by unexplained fever and other symptoms of infection. In most cases, this kind of reaction occurs within a few months of starting the drug; however, delayed onset reactions have also been described. If you experience these symptoms, you should contact your doctor immediately.