November 1997
Professor Studies Birth Defects of Accutane
A UMass Boston professor is one of only two researchers in the nation studying children exposed to isotretinoin, one of the most potent teratogenic (birth defect-causing) drugs on the market.
Dr. Jane Adams, associate professor of psychology, was recently awarded five-year grant of $926,727 from the National Institute of Child Health and Development of the National Institutes of Health. Her current project is titled "Isotretinoin Teratogenicity: Outcome at Age 10."
Isotretinoin, commonly known by its brand name, Accutane, is a powerful, acne-fighting drug prescribed to patients whose severe cystic acne does not improve with other treatments.
Adams and Dr. Edward J. Lammer of Stanford University have followed nearly 50 children nationwide who were exposed to the drug while in the womb.
About 25 percent of babies born to women using isotretinoin during pregnancy have physical abnormalities such as ear and jaw malformations, asymmetric faces and brain abnormalities.
Though physical abnormalities bypass some children, about half suffer from learning disabilities. "Many of the kids that look normal have learning-related problems," Adams said. She has found that many isotretinoin-exposed children struggle with visual perception (such as drawing shapes), spacial processing (such as piecing together a puzzle), and organizing behavior.
Parents often overlook signs, especially when language is a strong point, Adams said. The learning disabilities become more pronounced around the third or fourth grade, she said. Classes such as geography, mathematics and writing often pose challenges, as children are required to read maps, count in their heads and organize paragraphs.
Studying the teratogenic affects of isotretinoin has influenced policy. "I think our work will help detect disabilities earlier," Adams said. Vitamin A is chemically similar to isotretinoin. If taken by expecting mothers in large doses, it can also cause birth defects. "Studying Accutane allows us to understand the role of vitamin A in embryology," Adams said.
An important result of Adams' studies is the scientific proof that learning problems do stem from teratogenic drugs. "There have been a lot of animal studies that have shown this, but not a lot of human studies," she said.
Adams hopes her studies will change the current Food and Drug Administration (FDA) rules that do not require drugs to be screened for their ability to cause learning disabilities. Lammer's initial study influenced the FDA to require consent forms for women isotretinoin users. The form, part of the Pregnancy Prevention Program for Women on Accutane, requires women confirm their full understanding of risks associated with Accutane and pregnancy.
Consent forms, however, have not been successful in avoiding pregnancies in isotretinoin patients, Adams said. "It's not working. People are still getting pregnant, they're just having abortions," she said. A rising concern is that signed forms are not always understood, often due to language barriers.
Accutane will soon be rivaled in its teratogenic infamy. Thalidomide, a sedative and anti-nauseant taken off the U.S. market in the 1960s because of severe and widespread birth defects, will soon be available again. "The way Accutane has been marketed É has been used as a model for the drug," Adams said, noting that doctors may require consent forms prior to dispensing thalidomide.
Adams earned her B.S. at Florida State University and her M.A. and Ph.D. at New Mexico State University, all in psychology. In 1986 she received the FDA Commissioner's Special Citation. A member of the Publications Committee for Teratology and the Membership Committee for the Neurobehavioral Teratology Society, she is a past president of the Behavioral Teratology Society.