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The Food and Drug Administration (FDA) has announced that Covance has revised its iPLEDGE risk management programme to reduce the risk of fetal exposure to isotretinoin.
FDA officials said the changes will enhance the flexibility of the programme for users, reduce interruptions in treatment, and maintain the rigour of the scheme.
The iPLEDGE programme is designed to prevent fetal exposure to isotretinoin, a drug used to treat severe recalcitrant nodular acne, which can cause birth defects.
The changes, which were proposed by the FDA, Covance and the manufacturers of isotretinoin, were subsequently endorsed at a joint meeting of the Dermatologic and Ophthalmic Drugs and the Drug Safety and Risk Management Advisory Committees on 1 August.
The iPLEDGE program was implemented on 1 March, 2006, to minimise fetal exposure to the drug while providing a system to closely monitor patients who were taking the medication. The monitoring system is further supported by trained prescribers, pharmacists and other health care providers.
Isotretinoin and its generic equivalents are approved by the FDA for the treatment of severe recalcitrant nodular acne, a condition which does not respond to other drug treatments.
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