April 2022 Office of Women's Health e-Update
Message from the Associate Commissioner
Every April, National Minority Health Month highlights the importance of improving the health of racial and ethnic minorities and reducing health disparities. According to the Centers for Disease Control and Prevention, each year in the United States, approximately 700 people die during pregnancy or in the year after. Black women are three times more likely to die from a pregnancy-related cause than White women. This week marks Black Maternal Health Week, and as we bring awareness to this critical health topic, I encourage you to review and share our maternal health educational materials with your community.
In support of our commitment to advancing maternal health, I am pleased to share two upcoming programs with you. On May 9th, OWH will host a virtual public workshop in collaboration with the Johns Hopkins Center of Excellence in Regulatory Science and Innovation. This meeting will focus on opportunities, challenges, and regulatory perspectives on Leveraging Real-World Data to Study Medication Use in Pregnancy and Lactation. We invite you to learn more about this workshop here and encourage you to register today.
In addition, on May 11th, we will present a continuing education webinar developed in collaboration with FDA’s Division of Pediatric and Maternal Health. This program will help learners examine how prescription drug labeling can be used to inform prescribing in pregnancy and lactation. Additional details regarding the Pregnancy and Lactation Medication Information for the Healthcare Provider webinar are forthcoming.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
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.
- Give Your Community a Boost: Combatting Misinformation Through Communication and Research
- FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals
- Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm - FDA Safety Communication
CALL TO ACTION
Studies show that women are more likely than men to experience symptoms of stress. Many women have faced challenges during the COVID-19 pandemic that were stressful and sometimes overwhelming. Finding healthy ways to deal with stressful situations can go a long way in living a healthy and positive life. Stress Awareness Month is a great time to learn about how stress affects overall health and how to take steps to manage it in a positive way. Find out more about how stress affects health and healthy ways to cope. The FDA Office of Women’s Health has resources to help women live a healthier life at www.fda.gov/womens.
WOMEN'S HEALTH HIGHLIGHTS
FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging
Based on our recent review of published studies, the U.S. Food and Drug Administration (FDA) is recommending that newborns and children through 3 years old have follow-up thyroid monitoring within 3 weeks after receiving injections of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. Our review showed that underactive thyroid or a temporary decrease in thyroid hormone levels were uncommon.
FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs
The U.S. Food and Drug Administration announced it is requesting a total budget of $8.4 billion as part of the President’s fiscal year (FY) 2023 budget – a nearly 34% ($2.1 billion) increase over the agency’s FY 2022 appropriated funding level for investments in critical public health modernization, core food safety and medical product safety programs and other vital public health infrastructure. The request includes $3.7 billion in budget authority – including an increase of $356 million, and $3 billion in user fees – an increase of $153 million. The request also includes $1.6 billion in mandatory funding to support the FDA’s ability to prepare for future pandemics.
FDA Approves First Generic of Symbicort to Treat Asthma and COPD
The U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of two common pulmonary health conditions: asthma in patients six years of age and older; and the maintenance treatment of airflow obstruction and reducing exacerbations for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks.
Updates about Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Prioritized Replacement
The FDA updated its frequently asked questions about the Philips Respironics CPAP, BiPAP, and ventilator recall on FDA.gov to include information about Philips Respironics’ prioritization strategy for replacement devices.
After discussions with health care providers, experts in sleep medicine, and patient groups, the FDA shared with Philips Respironics the concerns of health care professionals and people who use these recalled devices, that for some patients, stopping use of the recalled device without an adequate alternative may involve significant risks to individual and public health. A first-come, first-served replacement strategy may not address these risks, or the risks from continued use of the recalled devices that such patients may face.
The FDA Provides Update on Adverse Event Reports for Essure
The U.S. Food and Drug Administration (FDA) remains committed to collecting and providing updates on the long-term safety information about Essure. Although Essure, a permanently implanted birth control device for women, has not been available for implantation since December 2019, the FDA continues to monitor the product’s safety through postmarket surveillance study data and other activities.
The FDA is providing an update from our ongoing postmarket evaluation of Essure by posting information on Medical Device Reports (MDRs) received by the FDA related to Essure in 2021.
FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers against the use of the Renuvion/J-Plasma device by Apyx Medical for certain aesthetic procedures. Specifically, the FDA is warning against the use for procedures intended to improve the appearance of the skin through dermal resurfacing (a procedure on the skin to treat wrinkles) or skin contraction (a procedure under the skin that can be performed either alone or in combination with liposuction to achieve skin effects, such as “tightening”).
FDA’s Third TechTalk Podcast Will Be on Artificial Intelligence
FDA will air the third in a new quarterly podcast series that focuses on the development and use of new technologies to accelerate prevention of food safety problems and speed responses to foodborne-illness outbreaks. The podcast will feature leaders in FDA and the private sector who will share their unique experiences and insights.
FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls
The U.S. Food and Drug Administration finalized guidance to help companies prepare to quickly and effectively remove violative products from the market. The guidance describes steps companies should take, before a recall is necessary, to develop recall policies and procedures that include training, planning and record-keeping to reduce the time a recalled product is on the market and, thus, limit the public’s exposure to risk.
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 Workshop: 7th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop, June 29, 2022
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.