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NEWS FROM THE FOUNDATION

When I Wish Campaign Highlights a Common Theme: I Wish I Knew More About Preeclampsia

We hear it time and time again -- "I wish I had known more about preeclampsia." Simply put, knowledge is power. This year's When I Wish Annual Giving Campaign is working to raise $25,000 to fund research to develop and test an effective hospital discharge tool for new mothers to include preeclampsia information.

With your help, we can ensure new mothers are educated that preeclampsia can strike even after delivery, when it's least

expected and most deadly, and that it's a risk factor for heart disease and stroke.

Antoinette H. wishes she knew more about preeclampsia's link to heart disease -- she was unexpectedly diagnosed with congestive heart failure two weeks after delivering her son prematurely due to preeclampsia. Antoinette wishes she was told about this possibility, before she was discharged from the hospital.

So far, you've helped us raise over $9,200 of our $25,000 goal! Awareness saves lives. Education saves lives. Make this wish come true for mothers, babies, and families everywhere. Please make your gift today.

ADVOCACY AND AWARENESS

FDA Issues Requirements for Pregnancy and Lactation Drug/Biologics Labeling

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.

GETTING INVOLVED

Chicago Volunteers in Action

The local volunteer team made a strong showing for improving healthcare practices at a November 19 perinatal training symposium at Advocate Christ Medical Center in Chicago. HELLP syndrome survivor and volunteer Johanna Aiken gave a presentation to approximately 200 clinicians in the audience to help them understand the patient experience of HELLP syndrome.

Volunteer Johanna Aiken speaks
to 200 clinicians at a training symposium at Advocate Christ Medical Center.

Aiken was joined by volunteers Nikki Mather and Melanie Dalponte, who talked with attendees at the Foundation's exhibit booth and handed out samples of our patient education materials. A highlight for the clinicians who visited the booth was the HELLP syndrome DVD, which was produced two years ago and offers continuing education unit (CEU) credits for healthcare providers.

This is yet another example of our Chicago volunteers' dedication. Several were recently recognized as Promise Walk Team of the Year -- Jasmine Mago, Melanie DalPonte, Nikki Mather, Elizabeth Pebelske, Jill Siegel, and Johanna Aiken. Together, they put on the best walk in the nation! In 2014, the Chicago Promise Walk and 5K Run was the top event in the nation, raising over $65,000 with over 500 participants.

Honored with this year's inaugural Promise Walk Team
of the Year Award, members of the Chicago team
raised over $65,000 with over 500 participants.

The success of the event was due in no small part to the hard work of the three lead walk coordinators, Mago, DalPonte, and Mather, building on the strong infrastructure of their predecessors Pebelske, Siegel, and Aiken. In addition, the Chicago volunteer team puts in many hours of mission work in Chicago through patient education and improving healthcare practices in their local community. See our website for more information on the Chicago Promise Walk profile.