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news.The FDA has implemented tighter controls designed to ensure that women do not take isotretinoin, Roche AG's drug to treat severe acne, during pregnancy. The US regulator said the changes would help prevent many of the miscarriages and birth defects associated with the drug.
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To obtain the drug, patients must now register with the program, named iPLEDGE, and also must comply with a number of key requirements that include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and complying with required pregnancy testing.
Doctors, wholesalers, and pharmacies must also comply with the manufacturers’ program requirements in order to distribute and dispense the product
“This stronger program is a major step in protecting against inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin.” said Dr Steven Galson, director, FDA’s Center for Evaluation and Research. “iPLEDGE, using a computer-based and telephone system, will provide health care professionals with the real time information necessary to effectively manage the risks of isotretinoin.”