Isotretinoin (also known as Accutane) is a drug used to treat severe acne, but it can cause birth defects when taken by pregnant women. Because of these risks, the U.S. Food and Drug Administration and Roche Pharmaceuticals (Accutane’s manufacturer) developed a voluntary pregnancy prevention program (PPP) in 1988 to try and prevent conception in women taking the drug. This program was replaced in the U.S. in 2002 with the System to Manage Accutane Related Teratogenicity (SMART), a program that placed more emphasis on pregnancy testing and contraception. A study published online October 14, 2005 in Birth Defects Research (Part A): Clinical and Molecular Teratology (www.interscience.wiley.com/journal/bdr) surveyed pregnant women who contacted a birth defect information service seeking information on the effects of isotretinoin. The purpose of the survey was to determine how the drug was dispensed in women who subsequently became pregnant and to identify possible reasons for failure in preventing conception.
