Message from the Associate Commissioner
Dear Women’s Health Colleagues,
September marks Sickle Cell Awareness Month, and as we shine a light on this inherited group of blood disorders, it is important to recognize the unique challenges that women face when living with sickle cell disease (SCD). SCD affects hemoglobin, the major protein that carries oxygen in red blood cells.
SCD affects more than 100,000 people in the United States, primarily affecting Black or African American populations. SCD affects both men and women, but the experience of managing the disease can be markedly different for women.
In SCD, some of the red blood cells are crescent or sickle shaped due to the abnormal hemoglobinSCD is a lifelong health condition that over time, can lead to serious health problems and organ damage.
Women living with SCD, often face additional challenges. In addition to navigating the complications of SCD, factors unique to women such as menstruation and pregnancy can make SCD particularly challenging. SCD may cause delayed puberty and for many women living with SCD, menstruation can trigger pain crises leading to increased hospitalizations. Pregnancy may also trigger or worsen sickle cell complications putting women living with SCD at higher risk for preeclampsia, preterm labor and infants with low birth weight. Given these risks, it is important that women living with SCD receive specialized care throughout their lives.
FDA OWH is committed to advancing the research that addresses the unique needs of women living with SCD. We are currently funding a study to generate tools to enable inclusion criteria for studying pharmacotherapeutics for SCD during pregnancy. Additionally, through continued efforts to ensure that clinical trials include diverse women to help improve the generalizability of trial results, we can foster scientific advancements to improve the lives of women living with SCD. Visit the Women in Clinical Trials webpage to learn more about participating in a clinical trial and to find a SCD study here.
In recognition of Sickle Cell Awareness Month, OWH hosted a Speaker Series webinar featuring guest speaker, Titilope Fasipe, MD, PhD., Co-Director, Sickle Cell & Thalassemia Program Texas Children’s Hospital, titled: Sickle Cell Disease: A Spotlight on Women. The webinar recording will be on the OWH website shortly.
We also invite you to read our latest OWH Knowledge and News on Women’s Health (KNOWH) blog guest authored by Dr. Fasipe on sickle cell disease and women to learn more about SCD including symptoms, treatment options, lifestyle recommendations for women living with SCD and ongoing research efforts. Please share the KNOWH blog post with your communities.
Sincerely,
Kaveeta P. Vasisht, M.D., Pharm.D.
Associate Commissioner for Women’s Health
Director, Office of Women’s Health (OWH)
  National Women’s Health and Fitness Day is September 25. This annual observance is held on the last Wednesday in September to help promote the importance of health awareness and fitness for all women.
You can take part by learning more about the importance of eating healthy, being physically active, managing your health conditions, getting regular checkups, and taking care of your mental health and encouraging all the women in your life to do the same.
Check out our free resources and tips to help you make healthy choices and manage health conditions at www.fda.gov/womens. Also, we encourage you to talk with your health care provider about any specific health concerns or questions you may have.
  National Hispanic Heritage Month honors the many achievements, histories, traditions, and cultural diversity of Hispanic/Latino Americans.
This observance is celebrated from September 15 – October 15 and this year’s theme is “Pioneers of Change: Shaping the Future Together.” OWH offers free Hispanic Women’s Health Tips for Healthy Living and Spanish language publications that you can read, download, and share in honor of National Hispanic Heritage Month.
 Women’s health news and updates
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FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause
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Last week, FDA released a Drug Safety Communication warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. Veozah is a nonhormonal prescription medicine approved in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. Patients should stop taking Veozah immediately and seek medical attention if they experience signs and symptoms that suggest liver problems such as feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of the eyes or skin, called jaundice; dark urine; swelling in the abdomen; or pain in the right upper abdomen. Stopping the medicine could prevent worsening liver injury and potentially return liver function to normal.
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Final rule to amend the Mammography Quality Standards Act (MQSA)
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The MQSA requires mammography facilities across the nation to meet uniform quality standards. Congress passed this law in 1992 to assure high-quality mammography for early breast cancer detection, which can lead to early treatment, a range of treatment options, and increased chances of survival. The FDA issued a Final Rule to Amend the MQSA Regulations (“2023 MQSA Final Rule”) on March 10, 2023. Facilities subject to the MQSA and its implementing regulations must now comply with all the requirements, including the breast density notification, as of September 10, 2024.
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FDA clears first device to enable automated insulin dosing for individuals with yype 2 diabetes
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FDA expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller previously indicated for the management of type 1 diabetes in individuals two years and older, to also include management of type 2 diabetes in individuals 18 years and older. An interoperable automated glycemic controller is software that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).
More updates from around
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