March 2022 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Colleagues,
During Women’s History Month, we celebrate the remarkable contributions women have made toward advancing our public health mission. Among these women is Alma LeVant Hayden, whose work played a pivotal role in advancing FDA's drug analysis capabilities in the 1950s and 1960s.
We invite you to learn more about the achievements of a number of trailblazing FDA women who made profound and enduring contributions to public health throughout their careers. Please explore their remarkable stories here.
This month we are also bringing awareness to Endometriosis. This is a condition which occurs when tissue similar to the lining of the uterus grows in other parts of the body. Endometriosis may affect more than 11% of American women between 15 and 44 years of age and is more common among women in their 30s and 40s. Women with endometriosis may experience pain and find it harder to get pregnant.
I encourage you to visit our March Knowledge and News on Women (KNOWH) blog to learn more about this important women’s health topic.
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 Postpones Advisory Committee Meeting to Discuss Request for Authorization of Pfizer-BioNTech COVID-19 Vaccine for Children 6 Months Through 4 Years of Age
- New FDA Resource on At-Home COVID-19 Diagnostic Tests
- Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers
- Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication
CALL TO ACTION
Although we have made a lot of progress in reducing HIV, according to the Centers for Disease Control and Prevention (CDC), in 2018, 19% of the new HIV diagnoses in the United States and dependent areas were among women. Women who don’t know they have HIV can’t get the care and treatment they need to stay healthy.
National Women and Girls HIV/AIDS Day (March 10) and National Native HIV/AIDS Awareness Day (March 20) are observances that help to remind us to increase awareness, start conversations, get tested, and show support for people with HIV our communities. Learn how HIV may cause health problems that are unique to women. Get the facts on women and HIV, HIV testing, prevention, and FDA-approved medicines for treatment of HIV. Women and HIV fact sheets are available in English, Spanish, and 11 other languages here.
WOMEN'S HEALTH HIGHLIGHTS
FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments
The U.S. Food and Drug Administration issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care.
Infant Formula: What to Know
If you use powdered infant formula, be aware certain Similac, Alimentum and EleCare products have been recalled and should not be used. The U.S. Food and Drug Administration (FDA) is investigating consumer complaints of bacterial infections in five infants who consumed powdered infant formula produced in Abbott Nutrition’s facility in Sturgis, Michigan. All five infants had to be hospitalized and the bacterial infection may have contributed to death in two patients.
FDA Approves Treatment for Wider Range of Patients with Heart Failure
The U.S. Food and Drug Administration approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults. Jardiance was originally approved by the FDA in 2014 as a supplement to diet and exercise to improve glucose control in adults with type 2 diabetes. Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction.
FDA Permits Marketing of First Condom Specifically Indicated for Anal Intercourse
The U.S. Food and Drug Administration authorized the marketing of the first condoms specifically indicated to help reduce transmission of sexually transmitted infections (STIs) during anal intercourse. The condoms, which will be marketed as the One Male Condom, are also indicated as a contraceptive to help reduce the risk of pregnancy and the transmission of STIs during vaginal intercourse. Before this authorization, the FDA had not cleared or approved condoms specifically indicated for anal intercourse.
FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States
The U.S. Food and Drug Administration is alerting the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated. The FDA is working with the company to initiate a voluntary recall of the affected products.
TCP HOT Acquisition LLC dba HRB Brands Issues Voluntary Nationwide Recall of Sure and Brut Aerosol Sprays Due to the Presence of Benzene
TCP HOT Acquisition LLC dba HRB Brands is voluntarily recalling all lot numbers with expiration dates on or before August 2023 of the Sure and Brut Aerosol Sprays listed in the table below to the consumer level due to the presence of benzene. While benzene is not an ingredient in any of the recalled products, our review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can.
Update: Essure Postmarket Study Information
The U.S. Food and Drug Administration (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 United States since December 2019, the FDA continues to monitor the product’s safety through an FDA-required postmarket surveillance study and other activities. The FDA is providing updates on interim results from two postmarket studies on Essure.
Tianeptine Products Linked to Serious Harm, Overdoses, Death
People seeking to treat their ailments sometimes mistake a product as being safe because it’s easily available, whether online or even at gas stations. But availability is no indication of effectiveness or safety. This is especially true of tianeptine, an unapproved drug associated with serious health risks and even death. Tianeptine is not approved by the U.S. Food and Drug Administration for any medical use.
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
- Public Meeting: FDA Rare Disease Day 2022, March 4, 2022
- Race & Genetic Ancestry in Medicine. A Time for Reckoning Racism, March 8, 2022
- An Overview of Tattoo Ink Research at the National Center for Toxicological Research, March 10, 2022
- Conversations on Cancer: “More Isn’t Always Better: Understanding Cancer Treatment Tolerability,” March 10, 2022
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.