NurseWeek

Kidney transplant drug recalled

By Noel Holton
Health24News
October 12, 2000


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Washington (H24N). Novartis Pharmaceuticals recently sent a letter to all health care professionals, warning them about potentially serious patient reactions to its kidney transplant drug Simulect.

The letter, which is posted on the Food and Drug Administration (FDA) MedWatch Safety Web site, alerts providers to the fact that since Simulect has been on the market, 17 patients have reported severe, acute, hypersensitivity reactions to the drug.

Novartis received FDA approval to market Simulect in May 1998 for the prevention of acute rejection episodes following kidney transplantation. Simulect is a selective immunosuppressant that works by blocking the receptor for the interleukin-2 protein that stimulates the proliferation of certain white blood cells called T-lymphocytes. T-lymphocytes help the body to accept the transplanted organ.

The adverse Simulect reactions that were reported include lowered blood pressure, difficulty breathing, cardiac failure, itching, pulmonary edema (fluid on the lungs), increased heart rate, hives and other rashes, sneezing, capillary leak syndrome and anaphylaxis, which is characterized by contraction of the smooth muscles and dilation of capillaries.

All of the reported reactions flared up within 24 hours of initial exposure to Simulect, or following re-exposure to the drug. It is recommended that 20 mg of Simulect be given to adult patients two hours before transplantation, and again four days after transplantation. For children ages 2 to 15, the recommended regimen is also two doses before and after surgery of 12mg/m2.

"If severe hypersensitivity occurs, therapy with Simulect should be permanently discontinued," wrote Stephen Cunningham, MD, Novartis vice president of medical affairs, and Alan Bless, MD, Novartis vice president of clinical safety, in the letter. "Patients previously administered Simulect should only be re-exposed to a subsequent course of therapy with extreme caution."

Health care professionals should report all serious adverse reactions related to Simulect use to the Novartis Pharmaceuticals Corp. at 59 Route 10, East Hanover, N.J. 07936; or telephone at (888) NOW-Novartis, which is (888) 669-6682.

Any information about Simulect may also be reported to FDA's MedWatch Reporting System by phone, 800-FDA-1088; by fax, 800-FDA-0178; online; or by mail, using Form 3500, to: MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20857.