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New FDA Rules Will Help Pregnant and Breastfeeding Women Understand Their Medication Options

Sandy MoreauIf you are pregnant or breastfeeding, you may wonder which prescription medicines are safe to take. Recently, the U.S. Food and Drug Administration (FDA) created new rules for drug manufacturers on what they should tell doctors and pharmacists about the risks of certain medications to pregnant or nursing mothers.

The FDA decided to no longer use letter-based categories (formerly called A, B, C, D, and X) to show risk. FDA officials believed the categories were confusing and unclear about the risks of a drug to pregnant and breastfeeding females and in females and males who wish to have children.

Now, information on prescription drug labeling will be organized into three categories:  pregnancy (including labor and delivery), lactation (including nursing mothers), and females and males of reproductive age.
The medication information for women who are pregnant will describe any known risks of birth defects or miscarriage. Your doctor will consider this information before prescribing this medication for you.

Your doctor or pharmacist may also see a reference to a “Pregnancy Exposure Registry,” which is a study that collects health information from women who take medications while pregnant. A list of existing registries can be found on the FDA’s Office of Women’s Health website. This collection of information tracks any problems with medications prescribed to pregnant or breastfeeding mothers and helps to improve a medication’s safety information.

The medication information for mothers who are breastfeeding describes the amount of a drug in breast milk and any possible effects on the breastfed infant. Some medicines cannot be used during breastfeeding.

The medication information for females and males of reproductive age applies to women of child-bearing age and their partners. This section includes information such as whether you should take a pregnancy test or not get pregnant before, during, or after taking the medication. It also will provide any known information about whether the medicine might affect your ability to get pregnant.

All new prescription drugs submitted by the manufacturer for FDA approval after June 30, 2015, must include information in this new format. Labeling for prescriptions drugs approved by the FDA on or after June 30, 2001, will be updated gradually. These changes do not apply to non-prescription medicines.

This new way of providing medication risk information will help you and your doctor or pharmacist decide what is best for you and your child.

By Pharm.D., BC, Pharm.D., BCPS, Clinical Pharmacist, Jersey City Medical Center, and Assistant Professor, Ernest Mario School of Pharmacy, Rutgers University