Remicade is a genetically engineered biological response modifier that contains infliximab and is indicated to treat rheumatoid arthritis with concomitant use of methotrexate, according to the product label. Methotrexate is a disease-modifying antirheumatic drug that can slow down the progression of rheumatoid arthritis. Research conducted by R.M. Fleischmann and published in "Expert Opinion on Drug Safety" in 2004, found that Remicade in concomitant use with methotrexate can cause infections, malignancies and adverse reactions to the medications.
Infections
Remicade in concomitant use with methotrexate can cause serious and opportunistic infections that include bacterial, viral, fungal and protozoal organism infections throughout the body in all organ systems. According to the product label, 5.3 percent of patients receiving Remicade combined with methotrexate developed serious infections compared to 3.4 percent of patients who received only methotrexate. The product label warns users that therapy should be stopped if the patient develops serious infections, such as tuberculosis with or without pulmonary diseases and invasive fungal infections that include histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis, which can each disseminate throughout the body. Hepatitis B virus can be activated among chronic carriers of the virus in patients taking Remicade and immune suppressants, such as methotrexate, according to the product label. Research conducted by J.M. van der Klooster and published in "Intensive Care Medicine" in 2003, found that combined treatment with infliximab and methotrexate induces severe immunosuppression that leads to multiple opportunistic infections that include tuberculosis, pulmonary aspergillosis, and herpes simplex virus. According to Drugs.com, a 66-year-old male with rheumatoid arthritis experienced West Nile virus coincident with infliximab and methotexate therapy, and later died from the infection.
Malignancies
According to the product label, malignant tumors and cancer have been reported among some patients taking Remicade and methotexate in treatment of rheumatoid arthritis during clinical trials prior to drug approval and in post marketing studies. These malignancies include tumors of the breast, colon, rectum and skin and acute and chronic leukemia. Lymphomas and other malignant tumors have also been reported in patients taking Remicade. According to Druglib.com, low-dose oral methotrexate can cause non-Hodgkin's lymphoma and other tumors; in some cases the tumors regressed following discontinuation of methotrexate treatment.
Adverse Reactions
Adverse reactions occur in 5 percent or more patients that receive Remicade combined with methotrexate for the treatment of rheumatoid arthritis, according to the product label. Adverse reactions involve the general body and gastrointestinal, respiratory skin, urinary and cardiovascular systems. The most common side effects from the most to least reported include upper respiratory tract infection, nausea, headache, inflammation of the sinus, inflammation of the throat, coughing, abdominal pain, diarrhea, indigestion, inflammation of the lungs, skin rash, fatigue, pain, urinary tract infection and high blood pressure. According to Drugs.com, adverse reactions are reported in higher proportions among rheumatoid arthritis patients who receive a higher dose of Remicade compared to patients who receive a lower dose.
References
- Centocor Ortho Biotech: Remicade Prescribing Information
- "Expert Opinion Drug Safety"; Considerations with the Use of Biological Therapy in the Treatment of Rheumatoid Arthritis; Fleischmann, R.M.; Sep 2004
- "Intensive Care Medicine"; Disseminated Tuberculosis, Pulmonary Aspergillosis and Herpes Simplex Infection with Infliximab and Methotrexate; van der Klooster, J.M.; Dec 2003
- Drugs.com: Remicade Side Effects
- Druglib.com: Methotrexate Warnings and Precautions
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