Isotretinoin (also known as Accutane) is a drug used to treat severeacne, but it can cause birth defects when taken by pregnant women.Because of these risks, the U.S. Food and Drug Administration and RochePharmaceuticals (Accutane's manufacturer) developed a voluntarypregnancy prevention program (PPP) in 1988 to try and preventconception in women taking the drug. This program was replaced in theU.S. in 2002 with the System to Manage Accutane Related Teratogenicity(SMART), a program that placed more emphasis on pregnancy testing andcontraception.
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 informationservice seeking information on the effects of isotretinoin. The purposeof the survey was to determine how the drug was dispensed in women whosubsequently became pregnant and to identify possible reasons forfailure in preventing conception.
Led by Julia Robertson of the Birth Defects and GeneticsProgram at the Utah Department of Health in Salt Lake City, researcherssurveyed 34 women who had called a member service of the Organizationof Teratology Information Services (OTIS) between April 2002 andSeptember 2004 because they had become pregnant while takingisotretinoin. "The results of the OTIS survey show that the majority ofwomen who participated were treated for less severe disease than isrecommended in the SMART program," the researchers state. A total of 24percent of the women reported receiving contraception counseling whiletaking the drug. In addition, the results showed that healthcareprofessionals and their patients failed to comply with a number of keySMART and/or PPP requirements. According to these requirements, womenmust have two negative pregnancy tests before receiving a prescription,yet 76 percent of the women in the study said they did not have asecond pregnancy test during menstruation. When asked about the SMARTrequirement of receiving a pregnancy test each month before refilling aprescription, 35 percent of the women surveyed said they did not havemonthly pregnancy tests during the therapy. SMART also requires womento use two forms of birth control simultaneously while takingisotretinoin, yet only 62 percent of the women reported using birthcontrol and only 29 percent of these women reported using two forms ofcontraception. In addition, only 53 percent of the women reportedsigning the informed consent required by SMART prior to taking thedrug.
The authors point out that the study's strengths include usingcounselors with extensive experience in communicating with women abouttheir reproductive concerns and the fact that most initial interviewswere completed within 3 months of exposure, before fetal outcome wasknown. They acknowledge that the study's limitations include the smallnumber of women surveyed and the fact that responses are based onpatient self-reporting and may be subject to recall error."Nonetheless, women were surveyed prior to the outcome of thepregnancy, so we believe the responses provided in this report can beuseful in elucidating important factors that hinder the success ofpregnancy prevention programs," the authors state.
Last year, the FDA began examining ways of designing a newpregnancy program with stricter requirements to preventisotretinoin-related birth defects and in August 2005 the new plan,called iPLEDGE, was announced. Beginning December 31, 2005, theregulations will require doctors and patients to register in anelectronic database before the drug can be dispensed. The plan alsoincludes the two pregnancy tests, two birth control methods, and othersafeguards previously recommended by SMART.
Article: "A Survey of Pregnant Women Using Isotretinoin," JuliaRobertson, Janine E. Polifka, Marina Avner, Christina Chambers, GeorgeDelevan, Gideon Koren, Sharon Voyer Lavigne, Lynn P. Martinez, RichardK. Miller, John C. Carey, Birth Defects Research (Part A): Clinical andMolecular Teratology; Published Online: October 14, 2005 (DOI:10.1002/bdra.20197).
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