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FDA to update product labeling for pregnant and breastfeeding women

We are all wary of taking drugs during pregnancy and nursing. But there are many among us who – for medical reasons – have to take medications, pregnant or not. I have to take thyroid replacement hormone everyday for the rest of my life. Others take pills for a wide range of pre-existing conditions such as asthma, allergies, epilepsy, or diabetes. It is estimated that in the US, pregnant women take on the average, 3 to 5 prescription drugs during pregnancy.

This is the reason why the US FDA has recent proposed to update the rules of labeling prescription drugs to give better and more detailed information of the effects of drugs to the unborn child or the nursing baby.

“Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.”

The new labels would contain a special sections on pregnancy and lactation. The “fetal summary risk” section should give all available information, be it on animals or humans, regarding this topic. The label should also reveal whether the drug has a pregnancy exposure registry, a registry which collects data on the effects of drugs prescribed to pregnant women.

In the lactation section, information about the amount of drug that is passed into the milk and possible effects to the nursing baby should also be given.

It is hoped that with the new labels, expecting and nursing mothers are better informed and protected.


FDA News 28 May 2008

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