Message from the Associate Commissioner
Dear Women’s Health Colleagues,
This month, OWH is raising awareness about uterine fibroids—benign muscular tumors that grow in and around the wall of the uterus. Uterine fibroids are the most common noncancerous tumors in women of reproductive age. While many women with fibroids are asymptomatic, others may experience heavy menstrual bleeding, pelvic pain, bowel and/or bladder problems, and infertility.
Uterine fibroids become more common as women age, especially during their 30s and 40s through menopause. Black women are more likely to develop fibroids compared to Asian, Hispanic, and White women. A family history of fibroids, being overweight or obese can also increase the risk of developing uterine fibroids.
To shed more light on this important women’s health condition, please take a moment to visit our dedicated fibroids webpage and read our free consumer fact sheet available in 13 languages. Additionally, watch our educational uterine fibroids video and learn about one woman's powerful personal journey of living with fibroids.
I also invite you to read the Women’s Health Highlights section below to learn about recent FDA drug approvals for Alzheimer’s and pregnancy prevention. In addition, FDA is sharing important information for health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products. Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. FDA is aware of compounded semaglutide products that are being marketed for weight loss and encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide. I encourage you to read the alert here.
Sincerely,
Kaveeta P. Vasisht, M.D., Pharm.D.
Associate Commissioner for Women’s Health
Director, Office of Women’s Health (OWH)
  July is International Group B Strep Awareness Month
Approximately 1 in 4 pregnant women test positive for GBS bacteria during routine screening towards the end of their pregnancy. Pregnant women can pass the bacteria to their babies during delivery which could lead to serious life-threatening infections for the newborn.
There are currently no vaccines to prevent GBS, but health care providers can take steps to help prevent GBS disease in the newborn. If you are pregnant, speak with your health care provider about getting tested for GBS bacteria. Receiving prenatal care is an important part of your pregnancy and can help keep you and your baby healthy. During your prenatal care visits your health care provider can test you for GBS and perform screenings to detect any health problems early.
For more information on free or reduced-cost prenatal care you can call 800-311-2229 toll-free to connect to resources available at your local health department.
This International Group B Strep Awareness Month visit the U.S. Centers for Disease Control and Prevention’s (CDC) webpage for more information on how to protect yourself and your baby.
  National Minority Mental Health Awareness Month
July is National Minority Mental Health Awareness Month. This annual observance brings awareness to the unique challenges that racial and ethnic minorities in the United States face with mental illness. Some of those challenges can include a lack of health insurance, less access to treatment, and stigma. Mental illness can affect women of all races and ethnicities.
Mental health includes emotional, mental, and social well-being and impacts how a person thinks and feels. It also affects how you act, manage stress, and make choices. When you take care of your mental health, you are better able to cope with stress or challenges.
 Women’s health news and updates
The U.S. Food and Drug Administration has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in the clinical trials. Alzheimer’s disease is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
The U.S Food and Drug Administration has approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
More updates from around FDA
News from around the Agency
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.
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