September 2022 Office of Women's Health e-Update
Message from the Associate Commissioner
Understanding your cholesterol status is an important part of staying healthy. Unhealthy cholesterol levels can increase your risk for heart disease and stroke, two leading causes of death in the United States. Since many people do not show any signs or symptoms of high cholesterol, it is important to talk to your healthcare provider about checking your cholesterol levels. We encourage you to learn more about cholesterol and FDA approved cholesterol medications in our recently updated Cholesterol Medicines guide.
I also invite you to join us for our upcoming virtual webinar on Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation. Additional details and registration information can be found below.
Sincerely,
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
UPCOMING OFFICE OF WOMEN’S HEALTH WEBINAR
On October 27, 2022, 12:00-1:00 PM ET, join the FDA Office of Women’s Health in collaboration with CDER’s Division of Pediatrics and Maternal Health for Part 2 of our discussion of the FDA Pregnancy and Lactation Labeling Final Rule, implemented in 2015. Although the current labeling system improved the presentation of information in prescription medication labeling, it highlighted the gaps in human data for medications used during pregnancy and lactation. The speakers will provide an overview of the studies enrolling pregnant and lactating individuals, the work FDA is doing to advance research in pregnant and lactating individuals, and information on how providers can become involved in advancing research in pregnant and lactating individuals. The webinar is open to the public and CME/CNE/CPE is available. Click here to register.
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 Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose
- FDA Authorized the Emergency Use of Novavax COVID-19 Vaccine, Adjuvanted for the Prevention of COVID-19 in Individuals 12 Through 17 Years of Age
- FDA’s Work to Combat the COVID-19 Pandemic
- FDA Safety Communication: At-Home COVID-19 Antigen Tests - Take Steps to Reduce Your Risk of False Negative Results
CALL TO ACTION
National Women’s Health and Fitness Day is a special day to promote the importance of health awareness and fitness for all women. The foundation of good health is the same no matter your age—eat healthy, be active, manage your health conditions, get regular checkups, and take care of your mental health.
Learn more about physical activity for women and talk to your healthcare provider about how to fit physical activity into your life. Women also have some unique nutritional needs, especially in different stages of life. For more information, check out healthy eating and women. Did you know that more than 1 in 5 women in the United States experienced a mental health condition in the past year, such as depression or anxiety? Read top questions about mental health and women to learn more.
The FDA Office of Women's Health has resources and tips to help you make healthy choices and to help manage health conditions at www.fda.gov/womens.
WOMEN'S HEALTH HIGHLIGHTS
Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The various lymphomas reported are not the same as the lymphomas described in previous FDA Communications as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The FDA learned about these reports through our continual postmarket review of breast implants and our ongoing collaboration with external stakeholders.
FDA Advises Parents and Caregivers Not to Buy or Give Mother’s Touch Formula to Infants
The FDA advises parents and caregivers not to buy or give Mother’s Touch Formula to infants under their care. The product is being marketed as an infant formula without the required pre-market notification to the FDA, and it does not meet infant formula nutrient requirements for seven nutrients.
Monkeypox Update: FDA Takes Significant Action to Help Expand Access to Testing
The U.S. Food and Drug Administration is announcing steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment to addressing the ongoing outbreak.
Fluorouracil and Pet Safety
The FDA has received reports involving dogs that were exposed to one type of medicated cream called fluorouracil. All the dogs died. If your medicine contains fluorouracil, immediately move it somewhere out of reach of your pets and keep them from licking your skin where you’ve applied the medicine. Why? Because fluorouracil, if ingested, can be deadly to pets.
Beware of Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation
The U.S. Food and Drug Administration continues to warn 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 you or any other 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.
FDA’s Overdose Prevention Framework Aims to Prevent Drug Overdoses and Reduce Death
The FDA Overdose Prevention Framework consists of four overarching priorities that align with the U.S. Department of Health & Human Services' Overdose Prevention Strategy to address the public health emergency as it continues to evolve. The overdose crisis is an evolving public health crisis; as such, FDA continues to evaluate our approach and make adjustments according to the latest available science and data.
Skin Facts! What You Need to Know About Skin Lightening Products
The FDA’s Skin Facts! Initiative alerts consumers of potentially harmful over-the-counter (OTC) skin products containing hydroquinone or mercury. These products are sometimes called skin lightening products and are not FDA approved for over-the-counter sale.
Update on Medtronic’s HeartWare Ventricular Assist Device System
The U.S. Food and Drug Administration (FDA) is providing updates on the HeartWare Ventricular Assist Device (HVAD) System. If you have questions about the Medtronic HeartWare Ventricular Assist Device (HVAD) System, contact the Division of Industry and Consumer Education.
FDA Alerts Patients, Caregivers, and Healthcare Providers of Incompatible Optional Autoinjector Devices for Glatiramer Acetate Injection
FDA is alerting patients, caregivers, and healthcare professionals that autoinjector devices that are optional for use with glatiramer acetate injection may not be compatible for use across FDA-approved glatiramer acetate injection drug products. FDA has received reports that using an autoinjector that is not compatible with the patient’s specific glatiramer acetate injection drug product has resulted in missed and partial doses.
FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies
The U.S. Food and Drug Administration issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product. These types of gummies are of particular public concern because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children.
FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans
The U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans. This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.
The rule is expected to lower the cost of hearings aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality healthcare, and lowering health care costs for the American public. It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace.
Updates on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recall
The U.S. Food and Drug Administration (FDA) provided the latest information about medical device reports (MDRs) received from May 1 to July 31, 2022, that are associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the June 2021 recall.
The FDA will continue to update the public about the status of the Philips Respironics June 2021 recall.
Tips to Stay Safe in the Sun: From Sunscreen to Sunglasses
Sun safety is always in season. It’s important to protect your skin from sun damage throughout the year, no matter the weather.
Sun exposure can cause sunburn, skin aging (such as skin spots, wrinkles, or “leathery skin”), eye damage, and skin cancer, the most common form of cancer in the U.S. The FDA continues to evaluate sunscreen products to ensure that they are safe and effective.
Information for Blood Establishments Regarding the Monkeypox Virus and Blood Donation
FDA continues to work closely with the CDC and other federal and international agencies to monitor reports of monkeypox and populations at greatest risk of infection. We are issuing this communication to provide information regarding monkeypox virus and blood donations.
Worldwide, there have been no reports of transmission of monkeypox virus through blood transfusion and the risk of transfusion-transmission remains theoretical. The levels of virus in the blood of an infected or exposed individual have not been well characterized.
FDA Issues Warning Letters to Three Companies for Selling Unapproved New Drugs for Mole and Skin Tag Removal
The U.S. Food and Drug Administration announced it issued three warning letters to companies for introducing mole and skin tag removal products into interstate commerce that are unapproved new drugs, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). There are no FDA-approved over-the-counter drug products for the removal of moles and skin tags.
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
- Real-World Data to Assess Variation in Opioid Prescribing and Use for Acute Pain in Diverse Populations, September 13, 2022
- FDA Oncology Center of Excellence Conversations on Cancer: Cancer Moonshot in Action: Launching the Next Generation of Cancer Leaders, September 14, 2022
- Webinar on the Policy for Monkeypox Tests, September 14, 2022
- Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration, October 24-25, 2022
- Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation, October 27, 2022
- 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.