The U provender and Drug Administr...

The U provender and Drug Administration (FDA) will be strengthening the risk minimization action plan for isotretinoin (Accutane), a influential teratogenic drug indicated for treatment of exact recalcitrant nodular acne. The plan calls for a centralized registry of isotretinoin pre-scribers, dispensers, and patients using the physic The registry should be available in July 2005 The registry will link physicians, pharmacies, and patients, ensuring that a negative pregnancy experiment result is obtained in women of childbearing potential before the remedy is dispensed. Informed consent, counseling, and ongoing patient eduction also will be documented. This enhanced plan is part of an effort by means of the FDA to reduce fetal aspects to isotretinoin. An FDA Talk Paper and question-and-answer materials are available online at http://www.fda.gov/cder/drug/infopage/Accutane/default.htm.

COPYRIGHT 2005 American Academy of Family Physicians

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