October 2021 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Women’s Health Colleagues,
Many of us know someone who has been affected by breast cancer—a friend, mother, sister, or maybe even yourself. Each year, approximately 255,000 women get diagnosed with breast cancer in the United States and 42,000 die from the disease.¹
Mammograms continue to be the best primary tool for breast cancer screening. Although screening cannot prevent breast cancer, it can help find cancer early, when it is easier to treat. National Breast Cancer Awareness Month serves as a great reminder to ask your healthcare provider about scheduling your mammogram. We invite you to learn more about mammograms here.
While breast cancer is one of the most common cancers among women and top causes of cancer related deaths; heart disease is a leading cause of death for both women and men. Diet is an integral component to preventing and treating heart disease. By limiting sodium, which is a component of salt in our diets, we can help prevent diseases like high blood pressure and heart disease.
In an effort to improve nutrition and reduce disease burden, FDA’s Center for Food Safety and Nutrition (CFSAN) issued a final guidance which provides voluntary short term sodium reduction targets for food manufacturers, chain restaurants and food service operators in an effort to decrease diet-related diseases. Please take a moment to learn about FDA’s nutrition efforts and steps you can take to reduce sodium in your diet.
Sincerely,
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
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 Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations
- FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children
- Know Your Treatment Options for COVID-19
- Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
- Ellume COVID-19 Home Test: Potential for False Positive Results
- FDA Updates on Hand Sanitizers Consumers Should Not Use
CALL TO ACTION
Bone and Joint Health National Action Week is observed on October 12-20. More than 10 million people in the U.S. have osteoporosis. Anyone can develop osteoporosis, but it is more common in older women. Even though osteoporosis affects mostly older women, prevention starts when you are younger. No matter your age, you can take steps to build bone mass and prevent bone loss.
For more information on osteoporosis, click here. Download our osteoporosis fact sheet or order in bulk for distribution to the women in your community at www.fda.gov/womenshealthpubs.
WOMEN'S HEALTH HIGHLIGHTS
FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency
The FDA announced it has authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by the FDA through the Premarket Tobacco Product Application (PMTA) pathway.
Do Not Use Needle-Free Devices for Injection of Dermal Fillers
The FDA is warning the public and healthcare professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers.
The FDA is aware of serious injuries and in some cases, permanent harm to the skin, lips, or eyes with the use of needle-free devices for injection of lip and facial fillers.
Specific Lots of Aerosol Sunscreen Spray Products by Coppertone: Recall - Due to the Presence of Benzene
Coppertone is recalling twelve lots of five Coppertone aerosol sunscreen spray products manufactured between the dates of January 10, 2021 and June 15, 2021. Coppertone has identified the presence of benzene in these lots. Benzene is classified as a human carcinogen. Exposure to benzene can occur through inhalation, oral, and skin and it could, depending on the level and extent of exposure, result in an increased risk of cancers including leukemia, and blood cancer of the bone marrow and other blood disorders which can be life-threatening.
Youth E-cigarette Use Remains Serious Public Health Concern Amid COVID-19 Pandemic
A study released by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) estimated that more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021, with more than 8 in 10 of those youth using flavored e-cigarettes.
Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND
The FDA issued a safety communication to warn consumers that use of the Max-Lux Safe-T-Lite UV WAND may expose the user or person nearby 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 consumers may use the Max-Lux Safe-T-Lite UV WAND to try to disinfect surfaces and kill germs in the home or similar spaces. The FDA recommends that consumers consider using safer alternative disinfection methods, such as general-purpose disinfectants.
Essure: Update on Adverse Event Reports
The FDA remains committed to providing updates on the safety profile of Essure, a permanently implanted birth control device for women. Although Essure has not been available for implantation in the U.S. since December 2019, the FDA continues to monitor the product’s safety through an FDA-required postmarket surveillance study and other activities. FDA is providing an update on the adverse event information received by Bayer (the company that manufactured Essure) as required in the April 24, 2020 variance from Medical Device Reporting requirements.
All Ultrasound Gels and Lotions by Eco-Med Pharmaceutical: Class I Recall - Due to Risk of Bacteria Contamination
All ultrasound gels and lotions manufactured by Eco-Med are being recalled due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). The FDA independently confirmed that distributed product tested positive for bacterial contamination. The use of affected ultrasound gels and lotions contaminated with Bcc may lead to serious infections, including bloodstream infections, which may result in sepsis or death.
Left Atrial Appendage Occlusion (LAAO) Devices Potentially Associated with Procedural Outcome Differences Between Women and Men
The FDA issued a Letter to Health Care Providers about the potential for differences in procedural outcomes between women and men undergoing implant of an LAAO device. A recent publication in the Journal of the American Medical Association (JAMA) Cardiology indicates that major adverse events and lengthened hospital stay may be more common in women compared to men.
It’s a Good Time to Get Your Flu Vaccine
Fall is here, and it is time to get your seasonal flu vaccine. It’s best to get vaccinated before flu viruses start circulating. Flu viruses typically spread in fall and winter, with activity peaking between December and February. Getting your FDA-approved flu vaccine now can lower your chances of getting the flu.
FDA Takes Steps Aimed at Improving Quality, Safety and Efficacy of Sunscreens
The FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs. In the short term, these new authorities essentially preserve status quo marketing conditions for these sunscreens. However, the agency proposed revisions and updates to those requirements related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements, and product labeling, among other provisions.
FDA Authorizes Software that Can Help Identify Prostate Cancer
The FDA authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue removed from the body). The software, called Paige Prostate, is the first artificial intelligence (AI)-based software designed to identify an area of interest on the prostate biopsy image with the highest likelihood of harboring cancer so it can be reviewed further by the pathologist if the area of concern has not been identified on initial review.
FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions
The FDA approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for Americans aged 65 years and older. Byooviz is also approved to treat macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).
Microneedling – Getting to the Point on Benefits, Risks and Safety
People are using microneedling in a variety of ways, from reducing the appearance of scars to treating fine lines and wrinkles to improve their appearance.
If you are thinking about having a microneedling procedure, the FDA recommends you choose a health care provider who is specially trained in microneedling. Talk with the provider to determine if you are a good candidate for microneedling—not everyone is. And discuss the benefits and risks, including the risk of infection if the microneedling tools are not cleaned or used properly.
Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure.
Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
FDA Releases Quiz About Prescription Drug Promotion and the Bad Ad Program
The FDA’s Bad Ad Program released the Bad Ad quiz to test your knowledge about prescription drug promotion and the FDA’s Bad Ad Program. The Bad Ad Program helps to ensure that information from prescription drug promotion that health care providers may use to inform their assessment of the risks and benefits of a drug is truthful, balanced, and not misleading.
5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC
Delta-8 tetrahydrocannabinol, also known as delta-8 THC, is a psychoactive substance found in the Cannabis sativa plant, of which marijuana and hemp are two varieties. Delta-8 THC is one of over 100 cannabinoids produced naturally by the cannabis plant but is not found in significant amounts in the cannabis plant. As a result, concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD).
It is important for consumers to be aware that delta-8 THC products have not been evaluated or approved by the FDA for safe use in any context. They may be marketed in ways that put the public health at risk and should especially be kept out of reach of children and pets.
Updates on Philips Respironics CPAP, BiPAP, and Ventilator Recall
The FDA updated the frequently asked questions (FAQs) about this recall on FDA.gov: Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions.
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
- FDA In Brief: FDA Announces Public Workshop to Reconsider Mandatory Prescriber Education for Opioids, October 13-14, 2021
- VRBPAC Meeting on Janssen and Moderna COVID-19 Vaccine Boosters, October 14-15, 2021
- New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers, October 19-21, 2021
- VRBPAC Meeting on Pfizer Data on Its COVID-19 Vaccine for Children 5-11, October 26, 2021