New drug labels for pregnancy lauded

Although drug manufacturers are required to include new safety information for pregnant and lactating women on their labels, much more clinical data is needed to determine whether products are safe for that population, according to professors and clinicians.

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“On the one hand, we have this wonderful change-the labels will be more content rich-but it also raises the huge issue of the need for more safety data for pregnancy and lactation,” said Christina Chambers, PhD, professor in the Department of Pediatrics and Family Medicine and Public Health at the University of California San Diego during a recent clinical drug information webinar, “The New Pregnancy and Lactation Labeling Rule: Implications for Clinical Practice.”

The Pregnancy and Lactation Labeling Rule, issued December 3, 2014, requires that all prescription drugs approved on or after June 30, 2001, must revise the content and format of the pregnancy and nursing mothers subsections of their labels. The drugs are required to remove the current A, B, C, D, or X “pregnancy letter categories” and replace them with an integrated risk summary. In addition, a new section “Females and Males of Reproductive Potential” has been added to the label. 

All prescription drugs approved prior to the 2001 cutoff date also will be required to remove the pregnancy letter categories. Although these drugs will not be required to migrate to the new risk summary format, manufacturers will be encouraged to voluntarily do so.

If the drug is systemically absorbed or contraindicated for pregnancy, the label’s risk assessment section must include that information. According to the timetable for the new rule, all new drugs approved on or after June 30, 2015, will be in the new format, while label updates for the older drugs will be phased in over the next 3 to 5 years.

NEXT: Addressing risk data

Addressing risk data

The label changes, which some pharmaceutical manufacturers implemented prior to the deadline, will clearly call for more and better quality data to help address the problem of “the lack of information for the majority of drugs out there now regarding safety in human pregnancy and lactation,” Chambers said.  

The lack of scientific risk data on many drugs stems from the fact that manufacturers typically cannot test the drug in pregnant women during clinical trials. “When we do have data, one of the major challenges is getting the type of data that translates to evidence-based information that can help physicians and pregnant women,” Chambers said. “Providers and patients can demand this kind of information from the manufacturers, so they feel there is a basis out there for conducting the studies and gathering the data,” added Allen Mitchell, MD, professor of epidemiology and pediatrics at the Boston University Schools of Public Health and Medicine, Boston, Massachusetts.

In addition, it has been difficult to get patients and physicians to consistently take part in pregnancy safety studies such as pregnancy exposure registries, according to Chambers. Now, to help encourage enrollment in these studies when they exist, drug labels must include at the beginning of the pregnancy section the statement that “There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to [name of drug] during pregnancy,” and provide contact information for that registry.

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Drug manufacturers also must include clinical considerations and the medical disease factors that might contribute to a woman’s or infant’s background risk, and that should be considered in deciding whether or not the drug is appropriate for pregnant or lactating women, according to Chambers. The risk summary must include human and animal studies, pharmacology, the risk in the general population and the risk in the disease population, if appropriate.

Ms Blank, based in Orlando, Florida, has written hundreds of articles for leading publications including The New York Times, Associated Press, USA Today, Drug Topics, and Formulary Journal. The author has nothing to disclose in regard to affiliations with or financial interests in any organizations that may have an interest in any part of this article.