August 2022 Office of Women's Health e-Update
Message from the Associate Commissioner
Education is a core component of our work in FDA’s Office of Women’s Health. In partnership with NIH’s Office of Research on Women’s Health (ORWH), we are pleased to offer the free e-learning course Bench to Bedside: Integrating Sex and Gender to Improve Health. This 6-module, online, self-paced course explores sex and gender related differences that impact health, disease, and treatment in several key disease areas. Topic areas include Immunology, Cardiovascular Disease, Pulmonary Disease, Neurology, Endocrinology, and Mental Health. All courses are open to the public and continuing education credits are now available for participants.
Please take a moment to learn more about this educational series and register for the modules here.
Sincerely,
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
INFANT FORMULA UPDATES
For the latest infant formula information and ongoing FDA efforts to increase supply, click here.
CORONAVIRUS UPDATES
Below are links to specific COVID-19 topics and the latest vaccine fact sheets, with a full list of the latest COVID-19 information from the FDA here.
- FDA Helps the Public Distinguish Between Rumors and Facts
- FDA Authorizes Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted
- FDA Updates on Hand Sanitizers Consumers Should Not Use
- Fraudulent Coronavirus Disease 2019 (COVID-19) Products
CALL TO ACTION
National Immunization Awareness Month is an annual observance to highlight the importance of vaccination for people of all ages, not just children. Adults need to keep their vaccinations up to date because immunity from childhood vaccines can wear off over time. You are also at risk for different diseases as an adult. You may need other vaccines based on your age, health conditions, job, lifestyle, or travel habits. Learn more about what vaccines may be recommended and talk to your healthcare professional about which vaccines are right for you.
Check out the FDA National Immunization Awareness Month 2022 Bilingual Social Media Toolkit to help spread the word about the importance of vaccinations.
WOMEN'S HEALTH HIGHLIGHTS
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
The U.S. Food and Drug Administration approved Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable (unable to be removed) or metastatic (spread to other parts of the body) HER2-low breast cancer. This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer.
FDA Releases New “Feed Your Mind” Education Materials on GMOs for Consumers, Health Educators, and Health Care Providers
The U.S. Food and Drug Administration (FDA) released new “Feed Your Mind” educational materials to provide science-based information on genetically modified organisms (GMOs) to consumers, health educators, dietitians, and other health care professionals. “Feed Your Mind” is an education initiative launched in 2020 to help increase consumer understanding of GMOs and was developed in partnership with the U.S. Department of Agriculture and the U.S. Environmental Protection Agency.
Vaccines Protect Children From Harmful Infectious Diseases
Vaccines are essential to getting children off to a healthy start in life and keeping them healthy as they grow up. Because immunization programs of the 20th and 21st centuries have been so successful, many parents today have never seen the many vaccine-preventable diseases that were once common. They may not realize that those infectious diseases could reemerge. If individuals choose not to vaccinate themselves or their children, some diseases that are now rare or nonexistent in the U.S. may resurface. The FDA ensures that the vaccines that we approve or authorize for emergency use in the U.S. meet our safety and effectiveness standards. FDA has some tips to keep in mind when your child is vaccinated.
FDA Provides Update on Agency Response to Monkeypox Outbreak
The U.S. Food and Drug Administration is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked questions. The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.
How Gene Therapy Can Cure or Treat Diseases
The genes in your body’s cells play a key role in your health. Indeed, a defective gene or genes can make you sick. Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition. This research is paying off, as advancements in science and technology today are changing the way we define disease, develop drugs, and prescribe treatments.
The U.S. Food and Drug Administration has approved multiple gene therapy products for cancer and rare diseases.
FDA Seeks to Improve Patient Communication on LASIK Benefits and Risks Through Issuance of Draft Guidance
The U.S. Food and Drug Administration issued a draft guidance to help ensure that information is available to patients and healthcare professionals to clearly communicate the benefits and risks of LASIK devices.
Voluntary Recall of Certain Over-the-Counter Products
Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled temperature requirements.
To date, Family Dollar has not received any consumer complaints or reports of illness related to this recall.
Want to Quit Smoking? FDA-Approved and FDA-Cleared Cessation Products Can Help
Are you or a loved one among those American adults who smoke cigarettes and want to quit? Whether this is your first attempt to quit smoking, or you’ve already tried several times, know that there are FDA-approved and FDA-cleared products that can assist you on your journey to becoming smoke-free.
Do Not Use Ultraviolet (UV) Wands: FDA Safety Communication
The FDA is warning consumers about the potential risk of injury associated with the use of certain brands of ultraviolet (UV) wands. Do not use these UV wands because they may expose the user or any nearby person to unsafe levels of ultraviolet-C (UV-C) radiation and may cause injury to the skin, eyes, or both after a few seconds of use.
The FDA is aware that some manufacturers are marketing unsafe UV wands to consumers to disinfect surfaces and kill germs in the home or similar spaces outside most health care settings. The FDA recommends that consumers do not use these products and consider using safer alternative methods.
FDA Approves Topical Treatment Addressing Repigmentation in Vitiligo in Patients Aged 12 and Older
FDA has approved Opzelura (ruxolitinib) cream for the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Opzelura is a topical Janus kinase (JAK) inhibitor currently approved for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Opzelura is the first FDA-approved pharmacologic treatment to address repigmentation in vitiligo patients. Opzelura is applied twice a day to affected areas of up to 10% of the body’s surface area. Satisfactory patient response may require treatment with Opzelura for more than 24 weeks. See full prescribing information for additional information on risks associated with Opzelura.
Honey-based or Honey-flavored Syrup Products Promoted and Sold for Sexual Enhancement may Contain Hidden Drugs that Could Harm You
On July 12, 2022, the U.S. Food and Drug Administration posted warning letters to companies that are violating federal law by selling products marketed as food which contain undisclosed or hidden prescription medication. These products are labeled as honey with herbal ingredients and are marketed with claims to treat disease or improve health.
These products are promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores. If you are struggling with sexual performance issues, you may have a physical condition that is keeping your body from responding as it normally would. Talk openly with your healthcare professional before considering any treatments.
Pregnancy Registry
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!
Participate in Upcoming FDA Meetings
- Bridging Efficacy and Safety to the Obese: Considerations and Scientific Approaches, November 9, 2022.
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.