Women's Health E-Update May 2023

Message from the Associate Commissioner

Dear Women’s Health Colleagues,

This year, National Women’s Health Week (NWHW) begins on Mother's Day, May 14th and serves as an important reminder for women to prioritize their health needs. The FDA Office of Women’s Health (OWH) theme for this year is #KNOWHmore About Your Health, Today and Every Day. We are encouraging women to #KNOWHmore by bringing attention to a range of health topics that are specific and important to women such as pregnancy, uterine fibroids, menopause, and osteoporosis.

We also invite you to read our NWHW OWH blog post focused on Polycystic Ovary Syndrome (PCOS) featuring Dr. Kathleen Hoeger, Professor of Obstetrics and Gynecology, and Chief of the Division of Reproductive Endocrinology at the University of Rochester Medical Center. PCOS is one of the most common causes of female infertility, affecting 6% to 12% of US women of reproductive age. Women with PCOS can also develop serious health problems. Dr. Hoeger shares informative insights on this important condition.

Please join us in recognizing NWHW by making your health needs a priority. We encourage you to visit our National Women's Health Week webpage and share our women’s health resources and social media posts with your communities.

Sincerely,

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

CORONAVIRUS UPDATES

Below are links to specific COVID-19 topics with a full list of the latest COVID-19 information from the FDA here.

• Lessons Learned from COVID-19 Are Informing Preparation for Future Public Health Emergencies
• Bivalent mRNA COVID-19 Vaccines
• Safely Using Hand Sanitizer
• Update: Expiration Dates Extended for Three OTC COVID-19 At-Home Tests
• FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19
• Extended Expiration Date: CareStart COVID-19 Antigen Home Test and On/go COVID-19 Self-Test
     

May is Asian American, Native Hawaiian, and Pacific Islander Heritage (AANHPI) Month. We’re celebrating the many contributions and achievements of these vibrant and diverse communities. Read and share our women’s health resources with all the AANHPI women in your communities.

This month of May, we would like to recognize Mental Health Awareness Month. More than 1 in 5 US adults live with a mental illness. This is a time to raise awareness and reduce stigma surrounding mental health conditions. Many are facing challenges that can be stressful and overwhelming. Learning to cope with stress in a healthy way will help you and the people you care about. Learn more about the symptoms of depression and download our medicine booklet for specific depression treatment information. Learn how to talk about mental health and how to get help for yourself or someone you care about.

• FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause
• FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease
• What to Ask Your Doctor Before Taking Opioids
• OTC Hearing Aids: What You Should Know
• FDA Takes Additional Steps to Advance Decentralized Clinical Trials
• FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting
• FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection
• FDA approves treatment of amyotrophic lateral sclerosis associated with a mutation in the SOD1 gene
• FDA Warns of Use of Selective Androgen Receptor Modulators (SARMs) Among Teens, Young Adults
• Apetamin — An Illegally Imported Weight Gain, Figure Augmentation Product
• FDA is Working to Combat the Epidemic of Diet-Related Chronic Disease through our Nutrition Efforts
• Ticks and Lyme Disease: Symptoms, Treatment, and Prevention
• FDA Updates Prescribing Information for All Opioid Pain Medicines to Provide Additional Guidance for Safe Use
• FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena 
• The U.S. has One of the Safest Food Supplies in the World 
• FDA Launches Lupus Treatment Consortium in Partnership with the Lupus Research Alliance 
• FDA Actions are Reducing Exposure to Contaminants in Our Most Vulnerable Populations 
• FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings 
• Update on Adverse Event Reports for Essure 
• Evaluation of Safety Concerns with Certain Dental Devices Used on Adults 
• FDA Approves First Over-the-Counter Naloxone Nasal Spray 
• FDA Releases New Educational Resources for Patients on Biosimilars  
• FDA Publishes Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market 
• FDA Takes Additional Steps to Improve Nutrition, Reduce Disease with Expanded Use of Salt Substitutes to Help Lower Sodium Intake 
• FDA Works to Further Improve Nutrition, Reduce Diet-Related Chronic Disease with Dietary Guidance Statements on Food Labels 
• Risks with Exactech Joint Replacement Devices with Defective Packaging – FDA Safety Communication 

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!

• Webinar Series to Discuss Infant Formula Food Ingredients and Packaging Requirements, May 24, 2023
• Public Meeting: Good Manufacturing Practices for Cosmetic Products, June 1, 2023
• Conversations on Cancer - National Black Family Cancer Awareness Week, Engaging the Generations, June 15, 2023

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