Message from the Associate Commissioner
Dear Women’s Health Colleagues,
This April, we are sharing several important public health observances and resources. OWH supports our colleagues in the Department of Health and Human Services (HHS) Office of Minority Health and FDA’s Office of Minority Health and Health Equity in highlighting important issues impacting diverse communities year-round, but especially this month to amplify the theme Vaccine Ready. I encourage you to learn about the COVID-19 resources that are available from FDA and our partner agencies in the Call to Action section below. OWH also has numerous women’s health materials available in English, Spanish, and recently updated publications in other languages to guide diverse communities of women in making healthy decisions every day.
This month, we also recognize National Young Adult Cancer Awareness Week, which aims to highlight issues surrounding cancer in individuals under the age of 40. In collaboration with the HHS Office of Women’s Health, we are featuring their new HPV VAX NOW campaign to increase awareness of the risk for human papillomavirus (HPV) related cancers and the protective benefits of the HPV vaccine. You can learn more about this effort to increase HPV vaccination rates among young adults in our April FDA OWH Knowledge and News on Women blog.
Kaveeta P. 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, with a full list of the latest COVID-19 information from the FDA here.
- Help Stop the Spread of Coronavirus and Protect Your Family
- Get the Facts from the FDA about COVID-19 Vaccines
- FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection
National Minority Health Month is a time to raise awareness about health disparities that affect racial and ethnic minority populations and encourage learning more about how to live healthier lives. This year’s theme is #VaccineReady. FDA Office of Women’s Health joins other federal agencies in empowering communities to get the facts about COVID-19. Learn more about COVID-19 vaccines from the FDA and our Office of Minority Health and Health Equity videos addressing vaccine hesitancy among racial and ethnic minority communities.
We are also acknowledging the importance of maternal health during Black Maternal Mortality Week, April 11-17. Black women have much higher rates of pregnancy and birth complications than White women. According to the National Institutes of Health, Office of Research on Women’s Health, the national severe maternal morbidity (SMM) rates have nearly doubled over the past decade, and the incidence of SMM was 166% higher for Black women than White women from 2012 to 2015. The FDA Office of Women’s Health has resources to help you make good choices about medicines, foods, and other products for you and your baby.
Women's Health Highlights
Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates
FDA is informing patients, caregivers, and health care providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance for complications or problems. The FDA has not cleared or approved ADM or mesh for use in breast reconstruction. The FDA is informing the public of our recent analysis and requesting prompt reporting of adverse events to help us better understand the risks.
Studies Show Increased Risk of Heart Rhythm Problems in Patients with Seizure and Mental Health Medicine Lamotrigine (Lamictal) in Patients with Heart Disease
An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine lamotrigine (Lamictal). We want to evaluate whether other medicines in the same drug class have similar effects on the heart and are requiring safety studies on those also. We will update the public when additional information from these studies becomes available.
What You Need to Know About Traumatic Brain Injury
FDA continues to study traumatic brain injury (TBI) and encourages the development of medical devices to help prevent, diagnose, and treat it. The latest information from the FDA includes updates on TBI causes, symptoms, and diagnosis, as well as details on a newly authorized device to help protect athletes’ brains from repeated minor impacts to the head.
FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care Settings
FDA announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation. “The ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections, which is a major milestone in helping patients,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
FDA Approves First in the World Device to Treat Patients with Congenital Heart Disease
FDA approved the first in the world non-surgical heart valve to treat pediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that carries blood out of the right ventricle to the lungs. The device is designed for patients who have severe pulmonary valve regurgitation (blood leaking backward into the right lower chamber of the heart), a condition that often results from congenital heart disease.
FDA Requires a Warning about Guillain-Barré Syndrome (GBS) be Included in the Prescribing Information for Shingrix
FDA has required a new warning about GBS in the Prescribing Information for Shingrix as a result of new safety data from a postmarketing observational study. In the study, an increased risk of GBS was observed during the 42 days following vaccination with Shingrix.
Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan Tablets, USP, 20 mg Due to Label Mix-Up
Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg.
FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm
FDA is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health problems. Some of these complications, which include fast or abnormal heart rhythm, high blood pressure, and paranoia, can lead to hospitalization, disability, or death. Reports of individuals abusing and misusing propylhexedrine have increased in recent years. Propylhexedrine is safe and effective when used as directed.
FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief
FDA issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application.
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!
- Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea, April 23, 2021
- Virtual Public Meeting - Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices, May 4, 2021
- Visit FDA Meetings, Conferences and Workshops to find out about available meetings.