| Concerned about the dearth of information available on the safety and effectiveness of medical products for pregnant and breastfeeding women, the U.S. Food and Drug Administration and many of its regulatory counterparts around the world say it is time to address inadequacies in research through a paradigm shift in the approach to studying medical products in these populations. Stories are all too common about pregnant women who are calling their doctors and scouring social media and the internet for advice on whether or not they should take a medicine, even for serious conditions like asthma, epilepsy, depression — or COVID-19. What they find instead are anecdotes and opinions, but little to no actual data about the safety or effectiveness of medications used during pregnancy. Historically, pregnant and breastfeeding women have been excluded from clinical trials, especially pre-approval, primarily due to concern about the real or perceived potential risk to the fetus or child. Take the case of COVID-19, where pregnant women suffer increased risks for severe illness — including illness that results in ICU admission, mechanical ventilation, and death — leading to worse outcomes for the pregnant woman and fetus compared to non-pregnant women. Pregnant women with COVID-19 are at increased risk for serious adverse obstetrical outcomes, such as preterm birth. | | | |
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