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June 2019 Office of Women's Health e-Update

Pregnant women holding their bellies

Message from the Acting Associate Commissioner

Dear Women’s Health Colleagues,

The theme of this month’s message focuses on maternal health. Last week, I had the privilege of participating in a Congressional briefing on FDA’s efforts to address recommendations from the Task Force on Research Specific to Pregnant and Lactating Women (PRGLAC). PRGLAC was established in 2016 by the 21st Century Cures Act to advise the Secretary of Health and Human Services about gaps in knowledge and research on safe and effective therapies for pregnant and lactating women.  As the FDA Commissioner’s designee to PRGALC, our office will continue working to facilitate implementation of the Task Force recommendations.

In support of our commitment to maternal health, we have launched an updated Pregnancy Social Media Toolkit. Details about this toolkit can be found in this E-Update under the Call To Action section. In this update, you will also find important information warning women of potential safety risks with dietary supplements containing vinpocetine. In addition, we are sharing an update on FDA’s commitment to postmarket evaluation of Essure, information regarding a recall of cosmetics containing asbestos, and much more.

We hope you continue to use our monthly updates to stay informed about the latest women’s health news from FDA.

Kaveeta Vasisht, M.D., Pharm.D. 
Acting Associate Commissioner for Women's Health

Women's Health Highlights

FDA Advises Consumers to Stop Using Certain Cosmetic Products 
The U.S. Food and Drug Administration is alerting consumers about cosmetic products recalled due to the presence of asbestos. On March 5, 2019 the FDA issued a Safety Alert warning consumers not to use certain Claire’s products. Today the FDA has updated its Safety Alert to warn consumers not to use two additional products: Beauty Plus Global Contour Effects Palette 2, Batch No. S1603002/PD-C1179; Claire’s JoJo Siwa Makeup Set, SKU #888711136337, Batch/Lot No. S180109 because they tested positive for asbestos. Last week both Beauty Plus and Claire’s recalled their respective products, and consumers who have these batches/Lots of Claire’s or Beauty Plus products should stop using them.

Statement on warning for women of childbearing age about possible safety risks of dietary supplements containing vinpocetine
The U.S. Food and Drug Administration is warning consumers about safety concerns regarding an ingredient called vinpocetine that is found in dietary supplements, specifically concerns about the use of this ingredient by women of childbearing age. According to data reviewed by the FDA, including a recent report by the National Institute of Health’s (NIH) National Toxicology Program (NTP), consumption of vinpocetine is associated with adverse reproductive effects – in other words, vinpocetine may cause a miscarriage or harm fetal development.

FDA provides updates on the agency’s continued commitment to evaluating postmarket safety of Essure device
As part of the FDA’s continuing commitment to regularly communicate with stakeholders about the permanent birth control device Essure, we are providing an update on our ongoing postmarket evaluation of Essure, so that patients and health care professionals have up-to-date information on this device to help them make more informed health care decisions,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Even though this device is no longer sold, I want to reiterate the FDA’s commitment to regularly communicating with patients and health care professionals about Essure as more information is made available. Our work to continually monitor the long-term safety profile of Essure is part of our broader effort to assure device safety, which includes ongoing actions to enhance our post-market surveillance system to identify and address new safety concerns once a device is on the market and to encourage innovations that lead to safer medical devices.

FDA Warns Against the Use of Unauthorized Devices for Diabetes Management
The U.S. Food and Drug Administration is warning patients and health care professionals of risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps and automated insulin dosing systems. In the safety communication issued today, the agency noted that the use of unapproved or unauthorized devices could result in inaccurate blood glucose (sugar) measurements or unsafe insulin dosing, which can lead to injury requiring medical intervention or even death.

FDA Advises Consumers, Tattoo Artists, and Retailers to Avoid Using or Selling Certain Tattoo Inks Contaminated with Microorganisms
The FDA is alerting consumers, tattoo artists, and retailers of the potential for serious injury from use of tattoo inks that are contaminated with bacteria. Tattoo inks contaminated with microorganisms can cause infections and lead to serious health injuries when injected into the skin during a tattooing procedure, since there is an increased risk of infection any time the skin barrier is broken.

FDA clears first diagnostic tests for extragenital testing for chlamydia and gonorrhea
The U.S. Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually-transmitted infections, respectively, chlamydia and gonorrhea, through diagnostic testing of extragenital specimens. The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of these infections via the throat and rectum. These tests were previously only cleared for testing urine, vaginal and endocervical samples.

Confused by Date Labels on Packaged Foods?
Between the food industry and consumers, Americans are throwing out about a third of our food — about $161 billion worth each year. “Imagine this: You go to your favorite supermarket and come out with three bags full of groceries. Before you get in your car, you toss one of those bags in the garbage. Sound ridiculous? Of course it does, but that’s in essence what food waste looks like every day across our country,” says Frank Yiannas, the FDA’s Deputy Commissioner for Food Policy and Response. Consumer uncertainty about the meaning of the dates that appear on the labels of packaged foods is believed to contribute to about 20 percent of food waste in the home. That’s not surprising when you consider the variety of terms used with date labels, such as “use before,” “sell by,” “expires on,” and many more. 

FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies 
The U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin (IgM) antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies—including the ZIKV Detect 2.0 IgM Capture ELISA—had been authorized only for emergency use under the FDA’s Emergency Use Authorization (EUA) authority.

FDA approves first PI3K inhibitor for breast cancer
The U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.

Call To Action

collage of images: pregnant woman with a health professional, pregnant woman holding her belly, woman kissing her baby, pregnant woman eating a healthy meal

Women’s Health Resources
We’ve updated our pregnancy toolkit! You can use the Pregnancy Social Media Toolkit to inform pregnant women in your network about food and medication safety as well as other topics. The toolkit includes resources for pregnant women and health professionals, including sample social media messages and blog posts. 


Participate in Upcoming FDA Meetings

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
June 19-20, 2019; Gaithersburg, MD

Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
June 20, 2019; Silver Spring, MD

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