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
Dear Women’s Health Colleagues,
Heart disease is the leading cause of death for women in the United States and many do not realize that they are at risk. Understanding that we have unique risk factors and can present with atypical symptoms is critical in fighting heart disease. In honor of American Heart Month, we would like to highlight the Cardiovascular Disease module of the Bench to Bedside: Integrating Sex and Gender to Improve Human Health course developed in partnership with the NIH Office of Research on Women’s Health. The module explores sex and gender differences in heart failure with preserved ejection fraction, coronary microvascular dysfunction, and spontaneous coronary artery dissection. We invite you to examine this module, as well as the entire course here.
Our February blog post is live and features Dr. Rupa M. Sanghani, Associate Director of Rush Women’s Heart Center. Dr. Sanghani shares important information and tips on how women can protect themselves from developing heart disease. You can learn more about women and heart disease by viewing our heart health video.
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, with a full list of the latest COVID-19 information from the FDA here.
- FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
- FDA Announces Advisory Committee Meeting to Discuss Janssen Biotech Inc.’s COVID-19 Vaccine Candidate
- FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers
CALL TO ACTION
February is Black History Month! Join us in celebrating the many contributions African-Americans have made and are continuing to make within the public health community. Please continue to share our important women’s health resources on topics including Diabetes, Heart Disease, and Mammography with your friends, family, community members and patients. All resources are available electronically and in print.
WOMEN'S HEALTH HIGHLIGHTS
FDA Response to Questions About Levels of Toxic Elements in Baby Food, Following Congressional Report
The FDA takes exposure to toxic elements in the food supply extremely seriously, especially when it comes to protecting the health and safety of the youngest and most vulnerable in the population. Toxic elements, such as arsenic and lead, are present in the environment and may enter the food supply through soil, water or air. Because these elements occur in the environment, currently they cannot be completely avoided in the fruits, vegetables, or grains that are the basis for baby foods, juices, and infant cereals made by companies or by consumers who make their own foods. They also cannot be completely avoided by using organic farming practices. Our goal is to reduce exposure to toxic elements in foods to the greatest extent feasible and to further advance progress in this area through more research and enhanced collaboration among stakeholders.
FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy Drug Is Given Before Chemotherapy to Protect Bone Marrow Function
The U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer. Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin- dependent kinase 4/6, a type of enzyme.
FDA Authorizes Marketing of Novel Device to Reduce Snoring and Mild Obstructive Sleep Apnea in Patients 18 Years and Older
The U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea. Unlike devices used while patients sleep, this is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep.
FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma
The U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, is the third gene therapy approved by the FDA for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.
Initial safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine Xeljanz, Xeljanz XR (Tofacitinib)
The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.
FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV
The U.S. Food and Drug Administration (FDA) approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month.
The FDA also approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.
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 2021, March 5, 2021
- Conversations on Cancer Black History Month Panel Discussion, “Living with Cancer While Black Clinical Trial Barriers, Part Two”, February 18, 2021
- Vaccines and Related Biological Products Advisory Committee February 26, 2021 Meeting Announcement
- Public Meeting on Patient-Focused Drug Development for Vitiligo March 8, 2021
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.