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From Barr, Bertek, Ranbaxy, Roche April, 2005 After receiving input from an Advisory Committee meeting in Februaury2004, the United States Food and Drug Administration began working with the innovator and generic manufacturers of isotretinoin to create a strengthened risk management program to prevent fetal exposure to isotretinoin. The FDA is concerned that although there are pregnancy prevention programs currently in place, the FDA continues to receive reports both that isotretinoin has been prescrined for women wh are pregnant and that women have become pregnant while taking isotretinoin. Pending implementation of the new program, which is anticipated for the third quarter of 2005, we want to remind you that it is essential to strictly follow the current risk management program set forth in the prescribing onformation for isotretinoin. It is crucial that any sexually active female pateint of childbearing potential selects and commits to use two forms of effective contraceoption simultaneously for one month before taking isotrretinoin, during therapy, and for one month after therapy is complete. She must have 2 negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/ml before receiving the initial isotretinoin prescription. Each month during therapy, the pateint must have a negative result from a urine or serum oregnancy test before receiving their next month's supply of isotretinoin. One component of the new program, which we recommend you institute now, is to verify pegnancy status using laboratory-based serum or urine pregnancy testing. Additionally, the label states isotretinoin is indicated for the trestment of severe recalcitrant nodular acne. It is not approved to treat less severe forms of acne where the risk-benefit ratio is less favorable. The label also states that no telephone or computerized prescriptions are permitted. We also recommend that you instruct patinets to obtain isotretinoin only after visiting a licensed healthcare provider. Please also refer to the attached eview of critical steps and contraception information that you need to know to follow the current program. Thank you for continuing your committment to the goal of this risk management program. If you have any questions, please call any of the phone numbers listed below. Sincerely yours, Christine A. Mundkur Sr. Vice Prsident of Quality and Regulatory Counsel Barr Pharmaceuticals, Inc. 1-866 CLARAVIS (1-866-252-7284)
James H. Sherry, M.D., Ph.D. Medical Director Mylan-Bertek Pharmaceuticals Amnesteem hotline 1-800-832-8583
Kathleen Spreen, D.O., M.S., M.P.H. Executive Director Medical and Clinical Affairs Ranbxy Laboratories Inc. The Sotret Resource Center 1-866-431-8179
Lars Birgerson, M.D. Vice President Medical Affairs Roche Laboratories 1-800-93-ROCHE (1-800-937-6243) |
