AAAAI supports FDA's pregnancy, lactation drug labeling change

The American Academy of Allergy, Asthma and Immunology supports the FDA’s final rule to change pregnancy and lactation labeling information for prescription drugs and biological products, according to a press release.

“This means more useful information regarding the safety of vaccines and medications during pregnancy will be available for clinicians and pregnant women,” Michael Schatz, MD, MS, FAAAAI, AAAAI investigator for the Vaccines and Medications Pregnancy Surveillance System and an allergist-immunologist at Kaiser Permanente Medical Center, San Diego, said in the release.

The new labeling requirements remove the current letter rankings of A, B, C, D and X used to classify prescription drug and biological product risks. They will be replaced by detailed subsections including pregnancy, lactation, and females and males of reproductive potential, which “describe risks within the real-world context of caring for pregnant women,” the release said. The final rule becomes effective June 30.

The subsections for pregnancy and lactation will include three subheadings entitled risk summary, clinical considerations and data.

“For many medical products, such as influenza vaccines and asthma medications, the bigger risk for the mother and the baby is the risk of the illness itself,” Schatz said. “In the case of asthma, for example, the data suggest that the risk of the uncontrolled asthma is substantially greater for both the mother and the baby than the risk of the commonly used asthma medications.

“Pregnant women must make the ultimate choice regarding their use of vaccines and medications during pregnancy — these label changes provide access to the most complete, current information available to allow them to balance the benefits and the risks of the therapy and the risks of the untreated disease as they make their decisions.”