Herbal Spotlight
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NEW WARNING
Novartis Pharmaceutical Corporation issued a "Dear Health Care Professional" letter about updates to prescribing information for their immunosuppressive drug mycophenolic acid (Myfortic). Mycophenolic acid is indicated for prevention of organ rejection in patients receiving allogenic renal transplants in combination with cyclosporine and corticosteroids. Postmarketing reports have shown cases of pure red cell aplasia (PRCA) in those taking the drug in combination with other immunosuppressive agents. PCRA was reversible with dosage reductions; however reducing the dose may increase the risk of organ rejection.
Novartis Pharmaceutical Corporation suggests monitoring blood counts and instructing the patient to report signs of infection, abnormal bleeding or bruising, or unusual tiredness, dizziness, or fainting. Health care providers are to report all serious adverse events to Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936 or by phone at 1-888-669-6682, Monday through Friday from 8:30 AM to 5:00 PM EST. Information may also be reported to the Food and Drug Administration's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.
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mycophenolic acid