Company: Edrugnet.com
Product:”Roaccutane Isotretinoin 10 mg capsules”
Date: 9/9/03
Accutane (isotretinoin) is a systemically administered retinoid approved in 1982 to treat severe recalcitrant nodular acne. Isotretinoin carries significant potential risks, including that it may cause severe birth defects. The approved Accutane labeling states in part, “Accutane must not be used by females who are pregnant…must be prescribed under the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.), a yellow Accutane Qualification Sticker must be on each prescription,” (meaning special training has been given to the prescribing licensed practitioner and the patient) “and no telephone or computerized prescriptions are permitted.”
Issuer: Center for Drug Evaluation and Research (CDER)
