FDA Changes Drug Labels For Pregnant Women
Wednesday, January 7th, 2015
If you’ve ever wondered if a medication was safe to take while you were pregnant or breastfeeding (um, hello, this morning, for me), then you will be excited to hear that, as of last month, the Federal Drug Administration issued an important rule to change up the labeling on the safety of drugs for pregnant and breastfeeding women.
According to the FDA’s official press release on the subject, “The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding.”
So what will the new labels look like?
Instead of the old system, which used a letter classification system with the letters A, B, C, D, and X, the new system aims to provide more-detailed information specific to each drug. Heck, I’m a nurse, and I still had trouble remembering which letter stood for what. A and B are generally OK, but C stood for what again? Cloudy?
The new labeling system will feature three different categories for:
- Pregnancy — Any known information about problems that the drug may cause in reference to the developing fetus, as well as special considerations for pregnant women. (Sometimes, the hormones of pregnancy will change how drugs work in the system.)
- Lactation — Full disclosure on how the drug will be excreted in the breast milk.
- Fertility — Helpful for couples trying to conceive, this subset will feature how the drug may affect fertility or pregnancy testing.
Unfortunately, however, there still isn’t a clear decision on how the new guidelines will be met by drug manufacturers. The FDA issued guidelines to help companies meet the new regulations, but for now, it will be at the manufacturer’s discretion. Obviously, it will be difficult to fit all the information pertaining to every drug on the outside of a bottle, so there are some that say that the new system will actually be more complicated.
“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,” said Dr. Adam Urato, a Maternal-Fetal specialist at Tufts.
What do you think of the new system?