AAAAI, VAMPSS Applauds FDA’s New Drug Labeling Requirements

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Final rule makes risks more transparent for pregnant women.

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"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..." Dr. Michael Schatz, MD, MS, FAAAAI

The U.S. Food and Drug Administration (FDA) yesterday issued a final rule that establishes labeling requirements for medicines, which, when taken during pregnancy and breastfeeding, could present risks to the mother and child.

“This means more useful information regarding the safety of vaccines and medications during pregnancy will be available for clinicians and pregnant women,” according to Dr. Michael Schatz, MD, MS, FAAAAI, American Academy of Allergy Asthma and Immunology (AAAAI) principal investigator for the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS) and an allergist-immunologist at Kaiser Permanente Medical Center in San Diego.

The final rule, issued December 3, 2014, replaces the current letter rankings – A, B, C, D and X – used to classify the risks of prescription drugs and biological products. New labels will include detailed subsections (Pregnancy, Lactation, and Females and Males of Reproductive Potential) which describe risks within the real-world context of caring for pregnant women. Labels must now also have a summary of the risks of using a drug during pregnancy and breastfeeding, a discussion of the data supporting the summary, and relevant information to help health care providers make prescribing and counseling decisions.

According to the FDA, there are well over six million pregnancies in the United States every year and pregnant women take an average of three to five prescription drugs during pregnancy. The main risks when prescribing drugs or medical products to women who are pregnant are adverse effects on the fetus, such as birth defects or prematurity. Expectant mothers with chronic conditions, however, are at an even greater risk.

“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. 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 commonly used asthma medications,” Schatz explained.

“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 risks of the therapy and the risks of the untreated disease as they make their decisions,” Schatz said.

“This development makes it even more important to perform valid and reliable studies regarding the safety of vaccines and medications during pregnancy, which is the purpose of VAMPSS,” he added. VAMPSS is a collaboration among the AAAAI, the Organization of Teratology Information Specialists Research Center at the University of California-San Diego (OTIS), and the Slone Epidemiology Center at Boston University (SEC). AAAAI support of VAMPSS emerged with the need to provide vital information for growing families with asthma, as asthma medications are one of the most frequently used drugs by pregnant women.

For more information on VAMPSS, including patient information, please visit the AAAAI website.

The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has more than 6,800 members in the United States, Canada and 72 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.

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Melissa Graham
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