By Dr. Adam Urato
Last week the Food and Drug Administration published a final rule that will change how drug companies present information on the risks of medications during pregnancy. This is considered a very important step as there are approximately 6 million pregnancies in the U.S. every year and the average pregnant woman takes between three and five prescription drugs during the course of a pregnancy.
For decades, the public has relied on the FDA’s Letter Category system in which a Category A drug was considered safe, Category D unsafe, with B and C falling in between, and Category X meaning contraindicated in pregnancy.
This past week the FDA announced that it is scrapping that letter system and replacing it with a new system that will offer descriptions about the effects of the drug during pregnancy and lactation. A third section (the “Females and Males of Reproductive Potential” subsection) will include information about pregnancy testing, contraception and about infertility as it relates to the drug.
So what exactly does all this mean for consumers?
As a Maternal-Fetal Medicine specialist, here’s my read on the changes:
What this means is that men and women are going to have to actually go to the drug information label and read it. No longer will a pregnant woman simply be able to look up a drug and find out that it’s a Category D in pregnancy, for instance, and then avoid it.
And this is a major problem that I see with the new system: many patients and physicians do not take the time to read through the label prior to using a medication. A description-based system risks losing the benefit of warning that the current Letter System provides when the drug is simply listed as Category D or X.
Also, it seems that the drug companies themselves are going to be asked to write these pregnancy sections on the label. This strikes me as absurd. Continue reading