The Food and Drug Administration (FDA) has approved a strengthened distribution
program aimed at preventing use of isotretinoin by pregnant women. Taken to
treat severe nodular acne, isotretinoin carries a significant risk of birth
defects if taken during pregnancy.
Under the manufacturers’ new program, called iPLEDGE, physicians
and patients must register and agree to accept specific responsibilities before
receiving authorization to prescribe or use the drug. For example, patients
must complete an informed consent form and obtain counseling about the risks
and safe use of the drug, and women of childbearing age must comply with required
pregnancy testing. Wholesalers and pharmacies must also comply with specific
program requirements to distribute and dispense the product.
Hampton T. Isotretinoin Risks. JAMA. 2005;294(12):1481. doi:10.1001/jama.294.12.1481-a