DRUGS USED IN PREGNANCY: THE REGULATORY PROCESS
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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
References
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7. FDA Center for Drug Evaluation and Research (CDER) Data Standards Manual. Post Marketing Commitments. Code 30.
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9. Drugs in Pregnancy and Lactation: Briggs GC, Freeman RK, Sumner JY. 7th ed Philadelphia: Lippincott Williams & Wilkins, 2005; xxvi, 1777-1791.
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