The Office of Women's Health e-Update highlights women's health initiatives, meetings, and regulatory safety information from the U.S. Food and Drug Administration (FDA). The e-Update is disseminated via email to the public.
Message from the Associate Commissioner
Millions of people live with diabetes in the United States. Diabetes can impact women differently than men. You can learn more about these differences by exploring OWH’s diabetes resources, which provide helpful tips on how to manage diabetes. We also encourage you to view our diabetes educational video to learn about the unique experiences of women living with diabetes.
Gestational diabetes is a type of diabetes diagnosed during pregnancy. Managing gestational diabetes includes lifestyle changes and possibly medication treatment. OWH is committed to supporting research, providing education, and advancing understanding of medication use in pregnancy and lactation. Last month, we collaborated with FDA’s Division of Pediatrics and Maternal Health to host a continuing education webinar on Engaging Providers to Address Knowledge Gaps on Medication Use in Pregnancy and Lactation. The webinar provided an overview of FDA’s work in this area and information on how providers can become involved in advancing pregnancy and lactation research.
I also invite you to read our recent publication on Behaviors Related to Medication Safety and Use During Pregnancy. This study investigated medication usage, including reasons for changes in use during pregnancy.
We encourage you to share our resources with your communities.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
INFANT FORMULA UPDATES
For the latest infant formula information and ongoing FDA efforts to increase supply, click here.
- What to Know About the Risk of Cronobacter in Powdered Infant Formula
- Certain Lots of Ready-to-Feed Liquid Products by Abbott: Recall - Due to Potential for Spoilage. Recall Is Not Expected to Impact U.S. Infant Formula Supply
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 Warnings on Fraudulent COVID-19 Products
- Novavax COVID-19 Vaccine, Adjuvanted is Available Under Emergency Use Authorization (EUA) to Prevent COVID-19 in Individuals 12 Years of Age and Older
CALL TO ACTION
Caregivers don’t have to do it alone. We provide resources and tips for those who take care of an aging, seriously ill, or a disabled family member or friend. View our caring for others resources to help keep loved ones healthy and safe.
WOMEN'S HEALTH HIGHLIGHTS
Warning: Aspirin-Containing Antacid Medicines Can Cause Bleeding
The next time you reach for a nonprescription drug to treat your upset stomach or heartburn, consider whether you should use one of the many antacids that don’t have aspirin. Why? Aspirin-containing medicines to treat heartburn, sour stomach, acid indigestion or upset stomach can cause stomach or intestinal bleeding in some people. Aspirin is commonly used to reduce pain and fever, but it can increase the risk of bleeding, including in the stomach and digestive tract.
Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication
The U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and healthcare providers not to use infant head shaping pillows intended to change an infant’s head shape and/or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows. These infant head shaping pillows are unapproved medical devices that may create an unsafe sleep environment.
Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage - Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is recommending healthcare providers discuss alternative options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures with patients if a facility is unable to perform the biopsy due to a shortage of Philips Invivo MRI breast biopsy grid plates and other Philips Invivo MRI disposables.
FDA Voices: FDA Continues to Advance Medicines for Children
The FDA recently completed 1,000 pediatric labeling changes, which is a milestone for the agency’s public health mission. This means 1,000 drugs contain information for pediatric use with the drug’s labeling information. Historically, more than 80 percent of approved drugs had no pediatric-specific labeling information. The FDA has made significant progress in making safe, effective treatment options available for children.
Coloplast Transvaginal Mesh: Final Results of Postmarket Study for Pelvic Organ Prolapse
The U.S. Food and Drug Administration (FDA) is providing the final results of the postmarket surveillance (“522") study on Coloplast transvaginal mesh for pelvic organ prolapse (POP). The study results showed the mesh had similar outcomes to native tissue repair (repairs without the use of mesh) at 36 months. However, devices of this type for transvaginal POP mesh repair present potential additional risks compared to native tissue repair, including mesh exposure and erosion. Based on currently available information, the FDA has determined that the benefits do not outweigh the risks of surgical mesh placed transvaginally to treat POP.
Although these devices are no longer commercially available in the US, the FDA required the manufacturer to continue follow-up of previously implanted patients already enrolled in its postmarket surveillance study.
It’s a Good Time to Get Your Flu Vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated in the fall can lower your chances of getting the flu.
Flu is a serious disease, caused by influenza viruses, that can lead to hospitalization and even death. Every flu season is different, and the substantial health impacts can vary widely from season to season, with some flu seasons being worse than others. Your best defense is vaccination, which provides protection from flu and its potential complications.
Monkeypox Update: FDA Authorizes Monkeypox Test
The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to Abbott Molecular, Inc., for the Alinity m MPXV, a real-time polymerase chain reaction (PCR) test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection. The Alinity m MPXV test is the first commercial test kit to be authorized for detection of monkeypox.
Update: Postmarket Study Activities for Essure
The U.S. Food and Drug Administration (FDA) remains committed to providing updates on our ongoing postmarket evaluation 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 from two postmarket studies for Essure.
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 Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (Monkeypox and COVID-19), November 30, and December 14, 2022
- CDRH Industry Basics: Understanding Risk with Medical Devices Workshop, November 15, 2022
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.