Acne drug program targets birth defect prevention.
2002
The drug Accutane is considered one of the most effective treatments for acne but it can also cause severe birth defects. The manufacturer Hoffman-La Roche is implementing a program aimed at ensuring that women are not pregnant when they begin using Accutane and don’t become pregnant while they are being treated. The System to Manage Accutane Related Teratogenicity program is an enhanced version of a previous education program for women on the medication. Under this program a female patient is required to have two negative pregnancy tests and commit to use two forms of birth control starting the first month before the treatment through a month after stopping to get an Accutane prescription. The patient also has to read and sign a consent agreement explaining the risk of birth defects associated with the drug. Moreover women must have a negative pregnancy test and get contraception counseling from the prescribing physician before getting a new prescription. Yellow Accutane qualification stickers then will be placed on the prescription container and only prescriptions with stickers attached are to be accepted.
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