FDA women’s health newsletter – February 2024: Learn more about hyperemesis gravidarum and join OWH in celebrating International Day of Women and Girls in Science, and American Heart Month.

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Message from the Associate Commissioner

Dear Women’s Health Colleagues,

Education and training are a key part of our mission in the FDA Office of Women’s Health (OWH). We host educational webinars for health care professionals and other stakeholders covering a broad range of health topics important to women. OWH recently hosted a webinar featuring Dr. Marlena Fejzo, Assistant Professor of Clinical Population and Public Health Sciences, Univ. of Southern California, Los Angeles, titled Hyperemesis Gravidarum: New Research and Insights. Hyperemesis gravidarum, or HG, is the medical term for the most severe form of nausea and vomiting experienced during pregnancy. This webinar reviewed the latest research on maternal, fetal, and child adverse outcomes for HG. I invite you to watch the recording (CME/CNE/CPE available), and learn more about this condition in our latest Knowledge and News on Women’s Health (KNOWH) blog post: Beyond Morning Sickness: Hyperemesis Gravidarum.

In honor of the International Day of Women and Girls in Science (Feb. 11)—an observance dedicated to recognizing and promoting the vital role that women and girls play in the field of science—I am pleased to share this new video by OWH team members discussing the importance of Science, Technology, Engineering, and Math (STEM) careers and why we need more young women in these industries. To learn more about careers in STEM, I encourage you to visit the FDA STEM website.

In addition, in this month’s newsletter we are sharing a recent drug safety communication from FDA concluding that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease. Learn more by reading the Women's Health Highlights section below and the safety communication.

Sincerely,

Kaveeta P. Vasisht, M.D., Pharm.D.

Associate Commissioner for Women’s Health
Director, Office of Women’s Health (OWH)

February is here, and with it comes the opportunity to focus on one of the most vital organs in your body—your heart.

American Heart Month is an annual observance celebrated in February. This observance is dedicated to raising awareness about heart health and the importance of adopting a heart-healthy lifestyle to prevent cardiovascular diseases.

Some key facts about women and heart disease include:

• Heart disease is the leading cause of death for women in the United States.
• Risk factors for heart disease in women include high blood pressure, high cholesterol, smoking, obesity and diabetes.
• Women may experience different heart attack symptoms than men, including back pain, chest pain or discomfort, shortness of breath, indigestion, nausea, and fatigue.
• Lifestyle changes such as healthy diet, regular physical activity, and avoiding tobacco play a crucial role in preventing heart disease.

This month, take action to keep your heart healthy. Get involved and help raise awareness among women about the importance of reducing risk factors, recognizing symptoms of a heart attack, and making heart-healthy changes. Join our promotional efforts this month by sharing OWH heart-related resources with your communities: Knowledge and News on Women’s Health (KNOWH) Blog (February 2023), Heart Health for Women Partner Social Media Toolkit (PDF, 6.81 MB), and other heart health for women resources.

Women’s health news and updates:

• FDA adds boxed warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab)
  FDA is investigating the risk of severe hypocalcemia (very low blood calcium levels) in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab). Preliminary results from an internal FDA study investigating hypocalcemia in dialysis patients treated with Prolia show a substantial risk with serious outcomes, including hospitalization and death.

• Handling infant formula safely: what you need to know
  Experts strongly recommend breastfeeding for infants. If that isn’t possible, babies will need infant formula. It’s extremely important that germs do not get into infant formula because babies do not have fully developed immune systems which puts them at higher risk for infections.

More updates from around FDA:

• FDA-approved devices that help keep the heart beating
• Don’t overuse Acetaminophen
• 10 facts about what FDA does and does not approve
• Lupus therapies continue to evolve
• FDA and CMS: Americans deserve accurate and reliable diagnostic tests, wherever they are made
• FDA safety communication: risks with Exactech Equinoxe Shoulder System with defective packaging
• Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
• FDA approves many new drugs in 2023 that will benefit patients and consumers
• FDA issues warning about certain Tejocote Root Supplements substituted with toxic yellow oleander

Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy.  Learn more about pregnancy registries today!

• February 27, 2024 - Public panel discussion: Conversations on Cancer, Real Talk: Our Stories as Black Oncologists at the FDA
• March 1, 2024 - Public meeting: FDA Rare Disease Day 2024
• March 5, 2024 - Public workshop: Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice
• March 19-20, 2024 - Public workshop: Enhancing Adoption of Innovative Clinical Trial Approaches

Visit FDA Meetings, Conferences and Workshops to find out about available meetings.