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FDA Issues Requirements for Pregnancy and Lactation Drug/Biologics Labeling

Created on Tuesday, December 09, 2014

The Food and Drug Administration (FDA) announced on December 3, 2014 that it has issued final standards for how label information should be included on prescription drugs and biological products used during pregnancy and lactation.

Called "The Pregnancy and Lactation Labeling Rule," the standards outline how drug manufacturers must label prescription drugs and indicate potential risks to pregnant women, women who are breastfeeding, and those who may become pregnant. The new labeling requirements go into effect June 30, 2015.

Under consideration by the FDA since 2008, the new standards will replace a decades-old labeling system. The hope of physician organizations is that the new labeling requirements will help healthcare providers with prescribing decisions and allow consumers to make more informed choices. Label requirements will now address prescription drug use during "labor and delivery," "lactation," and for "females and males of reproductive potential."

The Preeclampsia Foundation has long advocated for improved labeling standards to inform pregnant women on medications that can affect preeclampsia, their health, and the health of their babies. "For far too long, women have had a deficit of information about how the medications they need for other underlying health conditions can affect preeclampsia and their pregnancies," said Eleni Tsigas, Executive Director.

"The new FDA standards provide a first step forward, and it is the Foundation's hope that with the new labeling information, we will also see advancement in clinical research trials to provide women more information about their medications and to likewise support new therapeutics in the area of preeclampsia management.The implications for this effort have been documented in articles addressing off-label use and new medication development for treating preeclampsia.

Until now, physicians and their patients relied on an FDA labeling process that categorized a patient's risk of taking a prescription medication under a five-letter system (A, B, C, D, and X) based on the little and often outdated information available about products. The new system is meant to provide greater clarity and work to secure the collection of improved data about medications and their safety.

Members of the Foundation's Medical Advisory Board are cautiously optimistic about the new labeling requirements. One concern that still exists is whether there will be sufficient data on the safety and risk of most drugs for physicians and consumers to actually make informed decisions about their use. This issue was addressed by noted preeclampsia expert Jason Umans, MD, PhD, in an article published on the Preeclampsia Foundation's website.

"The Preeclampsia Foundation will continue to work with national provider organizations and lawmakers to advocate for improvements in clinical research for pregnant women," said Tsigas. "We need to take the next step forward in ensuring safe prescription drug use in pregnancy. The FDA's new labeling rules move us in a better direction, but more must be done to ensure women can be confident about the medication they are taking and so treatments for preeclampsia can be discovered."

To learn more, check out the FDA press release and consumer update on the new labeling system.

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    The Preeclampsia Registry is a "Living Database" bringing together those affected, their family members, and researchers to advance knowledge and discover preventions and treatments for preeclampsia, HELLP syndrome, and related hypertensive disorders of pregnancy.

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