Pharmacovigilance And Pregnancy

By Bart Cobert

Obviously, the safety of drugs in pregnant and breast-feeding women, the embryo/fetus and, less directly, the male partner are of paramount importance. Yet this is an area where little is known and little can be known. Unless drugs are specifically designed and indicated for use in pregnancy, it is not ethical or feasible to do clinical trials in pregnant women or in women actively breast feeding. Thus the only real data in this population comes from accidental or intentional exposure in pregnant women. This means limited anecdotal data. Where there is exposure, it is usually not feasible to work up the mother as most lab and invasive tests contraindicated unless there is a very strong indication for them. So no x-rays, scans, biopsies etc. in almost all cases. If there is exposure and no adverse event (AE) then usually no tests can or should be done. How the male partner who is exposed (rather than the mother) is worked up is also not clear or standardized.