Birth defects research. Part A, Clinical and molecular teratology
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Birth Defects Res. Part A Clin. Mol. Teratol. · Aug 2012
EditorialABCDXXX: The obscenity of postmarketing surveillance for teratogenic effects.
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. ⋯ 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.