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ABCDXXX: The obscenity of postmarketing surveillance for teratogenic effects


  • Jan M. Friedman

    Corresponding author
    1. Department of Medical Genetics, University of British Columbia, Child and Family Research Institute, Vancouver, British Columbia, Canada
    • Box 153, 4500 Oak Street, Vancouver, BC, Canada V6H 3N1
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  • I developed the TERIS system and am senior author of all its content. I have been involved in analysis of the data for a few National Birth Defects Prevention Study investigations, but I had no role in the design or collection of data for the NBDPS. I have never received payment from the NBDPS for anything. I have received honoraria for speaking at organization of teratology information specialists (OTIS) meetings, but I have never been involved in any OTIS research activities.


Our current system of postmarketing surveillance, which is based on voluntary reporting of suspected teratogenic effects, is a failure. Postmarketing surveillance should, at a minimum, provide reassurance that every approved drug treatment does not produce a teratogenic effect as great as thalidomide embryopathy or fetal alcohol syndrome. This means that postmarketing surveillance should be able to detect a twofold or greater increase in the frequency of major congenital anomalies, a fivefold or greater increase in the frequency of intellectual disability, or a characteristic pattern of minor anomalies and functional abnormalities that occurs with a frequency of at least 10% among the children of women who were treated with the drug during pregnancy. Effective surveillance for teratogenic effects could be accomplished through a complementary set of mechanisms that includes pregnancy exposure registries or cohorts as well as direct examination of a small subset of infants whose mothers received the treatment during various periods of pregnancy. If this routine surveillance reveals a “signal” (i.e., an indication suggesting a possible teratogenic effect), further study would be needed to establish whether the observed effect is real and causal. Once a signal of possible teratogenicity in humans has been recognized, validating or refuting it would become an urgent matter. Birth Defects Research (Part A) 94:670–676, 2012. © 2012 Wiley Periodicals, Inc.

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