FDA Action on the Brackbill-Broman Report on Long-term Effects of Obstetric Medication: Implications for Informed Consent


  • Madeleine H. Shearer R.P.T.

    1. Taught expectant and new parent education for ten years. She edits Birth and the family Journal, a medical care providers' and consumers' journal sponsored by the International Childbirth Education Association and the American Society for Psychoprophylaxis in Obstetrics.
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ABSTRACT: FDA testimony regarding the validity of the Brackbill-Broman research showing long-term effects of obstetric medications resulted in a conclusion that the study did not support long term effects, but that a subcommittee would be named to consider whether short-term drug effects warrant patient informed consent warnings. Action to encourage such warnings is described, both at the FDA and on the state legislative level.