Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on policies designed to capture more data to better understand effects of prescription drugs in pregnant and nursing women
It can be a challenge for health care professionals and patients to find quality scientific information about the safety of drugs and biological products when used during pregnancy or breastfeeding. Ethical challenges often arise in studying women in these populations as there are valid concerns about maternal and fetal safety. For example, if a woman who is currently breastfeeding starts an investigational drug for a disease or condition, breastfeeding should be discontinued for the duration of the study because the risks of the exposure to the drug in the breastfeeding infant may outweigh the benefits.
We also know that there are differences in how medicines affect men compared to women, and pregnancy can often add to these differences. But because of the challenges in studying this area, often, women and their health care professionals must make decisions about whether to use a drug during pregnancy or lactation even when relevant safety data are scant or lacking.
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