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.
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Message from the Director
As the summer winds down, the reviewers, safety officers, communications specialists and other staff at FDA remain busy protecting and advancing the health of women. Whether we are in the field inspecting mammography facilities, weighing the benefits and risks of products under review, reaching out to stakeholders, writing new guidance for industry or developing educational materials, our mission is the same – protect the public’s health. Our jobs are nuanced and challenging but we remain committed to providing the public, especially women, with the information they need about the safe use of FDA-regulated products. Check out the alerts and links in this update to stay informed about FDA’s ongoing activities impacting women across the lifespan.
Before you read on, I encourage you to take a minute to learn more about the life and accomplishments of Dr. Frances Oldham Kelsey. She is best known for leading the charge to deny FDA-approval of thalidomide - a drug that caused serious birth defects and deaths in many countries. However, Dr. Kelsey’s impact goes far beyond that one drug. Throughout her career she exemplified how women not only succeed in science and medicine but contribute to the fields in ways that set new standards of excellence for all. As we recognize her passing, I hope that you will join FDA in honoring Dr. Kelsey for her service and example.
FDA Approves First Treatment for Sexual Desire Disorder
FDA has approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
In order to ensure that the benefits of Addyi outweigh the risks of a potentially serious interaction with alcohol, the drug is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). After carefully reviewing the benefits and risks of Addyi, the FDA is requiring this REMS because an interaction between Addyi and alcohol increases the risk of severe low blood pressure (hypotension) and loss of consciousness (syncope). Health care professionals who prescribe Addyi and pharmacies that dispense Addyi must be certified with the ADDYI REMS Program, and must counsel patients about this risk.
Addyi is also being approved with a Boxed Warning to highlight the risks of potentially serious hypotension and syncope if a patient drinks alcohol during treatment with Addyi, in patients who are using medicines or supplements that interfere with the breakdown of Addyi in the body (moderate or strong CYP3A4 inhibitors), and in patients who have liver impairment.
Problem with Quality of Mammograms at Boston Diagnostic Imaging in Orlando, FL
The FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms. This does not mean that the results of the mammograms were inaccurate, but it does mean that the patients should consider having their mammograms re-evaluated at a Mammography Quality Standards Act (MQSA)-certified facility to determine if the patients need a repeat mammogram or additional medical follow-up. Patients have the right to request their mammogram and copies of their medical reports from Boston Diagnostic Imaging.
Webinar Series on New Pregnancy and Lactation Labeling
FDA is collaborating with DIA on a 4-part webinar series designed to introduce the recent revisions to the Pregnancy and Lactation Labeling Rule, discuss resulting policy decisions, and describe different approaches for proactively gathering relevant data. The format for this webinar series is a panel discussion including industry and academic experts, government and regulatory authorities and other stakeholders. The first webinar in the series will be held on September 15 at 11 a.m.
Back to School Resources
Help keep students safe. Teachers, parents, and health professionals can use these free FDA resources to prepare for the school year.
August is National Breastfeeding Month. FDA has resources to help women learn more about choosing and maintaining a breast pump. There are also tips on storing and heating breast milk.
Public Meeting: International Cooperation on Cosmetic Regulation
September 10, 2015
Harvey Wiley Federal Building, 5100 Paint Branch Parkway, College Park, MD
The FDA hopes to receive input from the public on various topics pertaining to the regulation of cosmetics to help the agency prepare for the International Cooperation on Cosmetics Regulation-9 (ICCR-9) meeting that will be held in November.
Obstetrics and Gynecology Devices Panel – Medical Devices Advisory Committee
September 24, 2015
FDA White Oak Campus, Silver Spring, MD
The committee will discuss the risks and benefits of Bayer HealthCare's Essure System for permanent female sterilization.
Public Workshop: Medical Device Patient Labeling
September 29-30, 2015
FDA White Oak Campus, Silver Spring, MD
The purpose of the public workshop is to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising.
OWH Conference Exhibits
The Office of Women’s Health exhibits and presents at conferences across the country to increase awareness of FDA’s women’s health resources and programs. Check out an OWH exhibit booth or presentation at one of these conferences:
- National Black Nurses Association, July 29- August2 – Atlanta, GA
- American Association of Diabetes Educators, August 5-8 – New Orleans, LA
- US Conference on AIDS, September 10-13 – Washington, DC