DRUGS USED IN PREGNANCY: THE REGULATORY PROCESS

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Anne Tomalin

Keywords

PREGNANCY, DRUGS

Abstract

Most drugs are not studied during pregnancy before  being  marketed.  In  my  over  30 years’ experience in the pharmaceutical industry I have never seen a drug studied during pregnancy before being marketed. Information on teratogenic potential is picked up in post marketing surveillance.   It   took   almost   four   years   of marketing  before  the  link  between  thalidomide and the adverse effects it was producing, i.e., phocomelia, was recognized. Malformations with warfarin took over 20 years to identify. Reproductive tract abnormalities with DES also took many years to identify. These were all picked up in post marketing surveillance and took many years to be understood

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References

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