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FDA Accutane Panel Says to Loosen Restrictions, Despite Risk of Birth Defects

www.newsinferno.com

Despite the fact that Accutane and other isotretinoin-containing medicines are still being used by pregnant women, a Food and Drug Administration (FDA) advisory panel recommended loosening restrictions on the drugs. Accutane and other drugs in its class are used to treat acne. However, these medications pose a substantial risk of birth defects if taken by pregnant women.

Just days before the FDA advisory panel made its recommendations, a report was released showing that the FDA’s iPledge program was not entirely successful in keeping the drug from expectant mothers. The iPledge program, which became mandatory last year, requires that all patients sign a document informing them of the drug’s risks. Patients must also agree not to share their medication with anyone else, and to make follow up visits with their doctors. The program has special requirements for women of childbearing age, including the requirement that they submit to regular pregnancy tests at their doctor’s office.

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