BOCA RATON, Fla., May 25, 2021 /PRNewswire/ — Medication usage during pregnancy has increased substantially over the last several decades. 80% of pregnant women in the U.S, Europe, and Australia, now use at least one medication during pregnancy and almost 50% of women use 4 or more drugs at some point in their pregnancy, with many of these drugs having a former D or X FDA classification label. Over a similar period of time, numerous chronic childhood illnesses have increased including neurodevelopmental delay, autism, asthma, ADHD and autoimmune illnesses. A relationship between these two trends has been suggested.
The Institute Of Etiological Research published the paper “The Assessment of Drug Safety for the Fetus” in the International Journal of Clinical Pharmacy and found the need to modify the study methods that establish drug safety for the fetus, due to the false assumption that medications used during pregnancy have undergone rigorous pharmacological fetal safety testing, and the likely undefined long-term health risks to a developing child following gestational exposure to some medications.
“I see this extraordinary increase in the usage of medication during pregnancy coupled with increases in childhood illnesses, and I wonder if the two are connected. Unfortunately, we don’t have adequate toxicological data when it comes to fetal exposure to medications,” says the executive director of the Institute of Etiological Research and lead author of the paper, Eric Hecht MD, MSPH, PhD.
Less than 10% of all FDA approved drugs obtain direct pharmacological data from pregnant women and their fetus despite the fact that most drugs pass through the placenta. Instead, what are obtained are animal reproductive toxicity data, which are inadequate, as animal species pharmacological data do not extrapolate well to humans.
The editorial by the Institute of Etiological Research, suggests that a combination of phase 1 and phase 3 randomized clinical trials conducted on pregnant women with long-term follow up for the children of these pregnancies is the only reliable method toward establishing drug safety for the fetus and child. “Obtaining this data is challenging but without it there can be no scientific basis for the establishment of drug safety for the evolving fetus,” says Eric Hecht MD, MSPH, PhD.
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SOURCE Institute Of Etiological Research