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Coming Soon: A Big Change for Pregnancy and Medication Labeling

In most cases, there are more questions than answers when it comes to how a medication will impact a pregnancy, and the current FDA labeling system unfortunately does little to help expectant moms make informed decisions.  Additionally, the current labeling system provides limited information for women who are trying to conceive or who are breastfeeding.

This is all about to change in June of this year when a new FDA labeling system will go into effect.  Beginning in June, moms and providers will both be armed with more information to be able to make informed decisions about which medications are worth the risk preconception, during pregnancy and when breastfeeding and which are not.

Why is the current letter grading system of A, B, C, D and X a problem? Very few medications actually fall into the safest category (A) or the most unsafe category (X).  The vast majority of drugs fall between these two clear-cut grades into the gray area, and there is limited information provided for conception or breastfeeding, which are also critically important times in a baby’s development.  The reason for this is pretty simple – most drugs are understandably not tested on pregnant women because of the inherent risk.  The information we do have has mostly been gathered over time or from studies on animals.

While it is always best to significantly limit the number, duration and dose of medications before, during and after pregnancy, there are many instances when it is in the best interest of both the baby and the mother – especially when managing an acute or chronic disease or illness– to take a medication.  With the new guidelines, pharmaceutical companies will be arming physicians and expectant moms with all of the information available on research studies and actual medication usage by pregnant women to help us make more informed decisions together. 

Your best resource for medication information is always your physician, but if you are looking online for a good resource with information about medications and pregnancy, I encourage you to visit MothertoBaby.org.  This is physician-run site features the most current information available.  You can also call the MothertoBaby.org toll-free number (866) 626-6847.

Again, it is always recommended that you discuss your medications with your health care provider.  If you are already on medications and are thinking about getting pregnant or are newly pregnant, you should discuss whether your medications are safe and if they need to be continued with your physician prior to stopping the medication on your own.  Your health care provider can help to weigh the pros vs cons of any medication use during or around the time of pregnancy.  Working together, we can all strive for happy, healthy, moms and babies!

Dr. Seth Brody is an OB/GYN with WakeMed Physician Practices and is the medical director for Wake County’s first Women’s Hospital currently under construction in North Raleigh.  Learn more about the new hospital.

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