FDA places severe restrictions on acne drug Accutane
작성자 관리자작성일 2019-12-31조회수 637
FDA places severe restrictions on acne drug Accutane
Under new requirements by the Food and Drug Administration, women and teenagers wishing to use the acne drug Accutane or its generic equivalents must enroll in a registry and agree to pregnancy testing and counseling.
The drug isotretinoin, marketed as Accutane, carries a significant risk of birth defects if taken during pregnancy. The risk exists until 30 days after a woman stops taking the drug. In 2004, at a joint meeting of two FDA advisory committees, committee members called for a stricter distribution program to ensure that no pregnant woman takes the drug and that women taking the drug don’t become pregnant.
It is important that ob-gyns know if any of their patients take Accutane. Counseling about contraception and sexual intercourse is especially important for teenagers taking the drug to ensure that they understand the importance of not becoming pregnant while taking Accutane. ACOG has several resources to help providers speak with teens about contraception and sex. Teen fact sheets on issues such as acne and contraception can be accessed on the ACOG website, and the Tool Kit for Teen Care can be purchased through ACOG’s bookstore (see info at left).
Beginning December 31, under the new program known as iPLEDGE, all physicians and patients will have to register before prescribing or using the drug and must agree to comply with requirements for office visits, counseling, birth control, and other responsibilities. Beginning October 31, wholesalers and pharmacists must register with iPLEDGE to obtain the drug from a manufacturer.
A reporting and collection system for serious adverse events associated with the drug has also been implemented. All pregnancy exposures to isotretioin must be reported immediately to the FDA through MedWatch, at 800-FDA-1088, or through the iPLEDGE website.