

A final rule issued by FDA December 3 will change the way labeling information is presented on prescription medications used during pregnancy and breastfeeding.

The rule replaces the current letter labeling categories—A, B, C, D, and X—on prescription drugs and biological products with more detailed information on clinical considerations and risks to pregnant women and mothers, as well as supporting data, categorized in three subsections.

The new requirements go into effect on June 30, 2015. Manufacturers of new approved drugs will be required to use new labeling immediately. For previously approved products, new labeling will be phased in gradually.

“The hope is that this new system in drug labeling will help health care professionals and women as they discuss treatment options,” said Sandra Kweder, MD, Deputy Director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research.

New labeling structure

Jan Shepherd, MD, Adjunct Associate Professor at Florida State University College of Medicine, said the old labeling encouraged practitioners to make black and white decisions, and it didn’t help much in prescribing Category C medications.

“With more detailed information, anyone involved in patient care—and patients themselves—can weigh a drug’s risk and benefits for that individual woman in her particular situation,” she said.

The first section of the new labeling structure includes information pertaining to pregnancy, including dosing that could be different if a woman were not pregnant; risks to the developing fetus; and information about whether there is a registry that collects data on how pregnant women are affect­ed when using the medication. The section on lactation provides information such as the amount of drug in breast milk, if it can be determined, and the potential effects on the child. The third section pertains to females and males of reproductive potential.

Shareen El-Ibiary, PharmD, FCCP, BCPS, Professor of Pharmacy Practice at Midwestern University College of Pharmacy–Glendale in Arizona, said an important piece in the new labeling is information on the potential risks of not treating a condition.

“The old categories were focused more on the negative effects to the fetus and child or what it might do to labor and delivery, but it didn’t give information about what would happen if you didn’t treat a mother who had hypertension or epilepsy, for example,” said El-Ibiary.

Kweder called the new labeling “user-friendly” and said that it’s relevant information that has been missing for many years.

“The old labeling was very simplistic and hard to make sense of,” she said.

More detailed labeling

However, some argue that having to read a lot of information is not ideal.

According to Shepherd, interpreting more detailed labeling will certainly require a greater time commitment, but the trade-off is better patient care.

“In some cases, the new labeling may even save time by avoiding the need to consult additional sources for information or drug dosing adjustment,” she said.

A related danger could also be the temptation not to read the more detailed labeling when one is pressed for time.

“I do wish the FDA had kept at least the A and X ratings for quick reference, and I hope there will be a brief summary available somewhere in the labeling,” said Shepherd.

Since May 2008, when the proposed rule was released, FDA sought input from various stakeholders to develop the final rule. The new rule contains many of the same provisions in the proposed rule.

APhA generally supported the May 2008 proposed rule but asked FDA to maintain at least part of the current risk classification system for clinicians to use as a quick reference for drugs that are either clearly safe or clearly harmful.