FDA Issues Final Rule Changing Pregnancy and Lactation Labeling on Prescription Drugs

Are you pregnant or breastfeeding and wondering if you should take your prescription medication? The Food and Drug Administration (FDA) is taking steps to clear up the confusion.

Recently, the FDA announced it is overhauling the way prescription medications are labeled to make it easier for women and their healthcare providers to determine what is safe to take.

“There’s a lot of new information that is available now on the use of medications in pregnancy and lactation that the old system doesn’t take into account,” said Bryan Coehrs, PharmD, RPh, ProMedica Pharmacy. “This new approach seems to be more evidence-based, which should help us educate our patients to make informed decisions.”

The new labeling system creates three categories – Pregnancy, Lactation and Females and Males of Reproductive Potential.

  • The Pregnancy subsection will provide information on the use of the drug in pregnant women such as dosing and the potential risks to the unborn child.
  • The Lactation subsection will provide information about using the drug during breastfeeding such as the amount of the drug in breast milk and the potential effects on the nursing child.
  • The Females and Males of Reproductive Potential subsection will provide information on how the drug impacts pregnancy testing, contraception and infertility.

It replaces the current letter categories of A, B, C, D and X, which was considered confusing.

“The old system didn’t provide much guidance,” said Coehrs. “There was a lot of subjectively built into the assessment of whether the benefits of the drug outweigh the risk.”

According to the FDA, there are six million pregnancies in the United States every year and pregnant women take an average of three to five prescription drugs during pregnancy. Some women with chronic conditions such as asthma, depression or diabetes may be required to continue taking the medications they were on before getting pregnant. They may also require treatment for new conditions that develop during pregnancy or if existing conditions that worsen.

The new rule goes into effect June 2015. Newly approved prescription drugs must use the new system immediately while older drugs will phase in the new labels over the next few years. It does not apply to over-the-counter medication.