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June 2020 Office of Women's Health e-Update


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Message from the Associate Commissioner

Dear Women’s Health Colleagues,

As we near the official start of summer, many of us are searching for new and innovative ways to stay healthy while navigating daily routines impacted by COVID-19. This may be particularly challenging for the elderly. We have resources available to help you develop and maintain healthy aging habits while spending more time at home.  

FDA continues to act on critical women’s health and safety issues which are highlighted in this month’s newsletter. These include the recent approval of a new treatment for heavy bleeding associated with uterine fibroids and issuing warning letters to two breast implant manufacturers for failure to comply with various regulatory requirements. In addition, I encourage you to read below to learn about the first FDA-approved drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. This approval is especially timely as we recognize Alzheimer’s and Brain Awareness Month in June.

In this month’s e-update, you will also find information from FDA and our federal partners related to COVID-19.


Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health


Below are additional links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.


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Did you know that women are two times more likely to develop Alzheimer’s disease compared to men? In recognition of Alzheimer’s and Brain Awareness Month, the FDA Office of Women’s Health (OWH) encourages you to learn more about clinical trials and how they can help healthcare researchers better understand the brain and this disease. Visit OWH at www.fda.gov/womeninclinicaltrials for resources to help you and the women in your community get the facts about clinical trials.

Alzheimer’s disease also affects women who are in caregiving roles. As families navigate through the COVID-19 pandemic, these caregiving responsibilities may become heightened. OWH has resources for women who may be caring for a loved one with Alzheimer’s disease or other chronic illnesses. Visit www.fda.gov/caregivertips for tools women can use to help them through the rewarding, yet challenging parts of caregiving. Please share messages from our Caring for Others Social Media toolkit to your networks and download the Caring for Others: Resources to Help You fact sheet in English and Spanish


Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets

Allergan Aesthetics Launches Dedicated Multi-Channel Campaign to Contact Patients Who May Not Be Aware of The Biocell® Recall
Allergan Aesthetics, an AbbVie company (NYSE: ABBV), is initiating a new digital campaign to improve device tracking and further identify and reach breast implant patients who have, or have had, BIOCELL® breast implants and/or tissue expanders to inform them of the risk of BIA-ALCL. Since July 2019 when the BIOCELL® recall was announced, robust efforts were made to reach patients, however, the Company is still seeking to directly contact all U.S. BIOCELL® patients that have not yet been notified. This is due to incomplete device tracking data for approximately 52,000 BIOCELL® breast implant units.

FDA Alerts Patients and Health Care professionals of Amneal and Impax Laboratories Epinephrine Auto-Injector Device Malfunctions
FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present. In letters to health care professionals and consumers, Impax Laboratories LLC, a subsidiary of Amneal Pharmaceuticals LLC, the manufacturer of the epinephrine auto-injector, detailed how certain lots of these devices might not contain the yellow “stop collar” component. If the auto-injector is missing the yellow “stop collar” component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient. It is vital for lifesaving products to work as designed in an emergency situation.

FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women
The U.S. Food and Drug Administration granted approval to Oriahnn (an estrogen and progestin combination product consisting of elagolix, estradiol and norethindrone acetate) capsules, co-packaged for oral use, for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

FDA Issues Warning Letters to Two Breast Implant Manufacturers as Part of Ongoing Efforts to Protect Patients
The U.S. Food and Drug Administration issued warning letters to two breast implant manufacturers for failure to comply with various regulatory requirements. The agency issued a warning letter to breast implant manufacturer Allergan of Irvine, California, for failing to comply with requirements—under two separate premarket approval orders—to conduct post-approval studies to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year. The FDA also issued a warning letter to Ideal Implant Incorporated of Dallas, Texas, for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted earlier this year.

FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products
The U.S. Food and Drug Administration is announcing that agency laboratory testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several lots of the extended-release (ER) formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. The agency is in contact with five firms to recommend they voluntarily recall their products. Company recall notices will be posted on FDA’s website. There are additional manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled.

FDA Requests Input on Rare Disease Clinical Trial Networks
For the approximately 7,000 known rare diseases, less than 10% have an FDA-approved treatment available. As drug development for rare diseases can be challenging due to the small number of patients and limited understanding of the variability and progression of the diseases, the FDA is committed to developing bold new approaches to harness the infrastructure of global clinical trial networks.

The U.S. Food and Drug Administration announced a Request for Information and Comment on Rare Disease Clinical Trial Networks. In particular, the FDA is requesting public input on practical steps and successful approaches relating to the start-up, implementation and sustainment of global clinical trials networks, including specific considerations for establishing such networks for a range of rare diseases.

FDA Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease
The U.S. Food and Drug Administration approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. Tauvid is a radioactive diagnostic agent for adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease. Tauvid is indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs), a primary marker of Alzheimer’s disease.

FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion
The U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers – in patients whose tumors have an alteration (mutation or fusion) in a specific gene (RET or “rearranged during transfection”). Retevmo is the first therapy approved specifically for cancer patients with the RET gene alterations.

FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors
The U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line treatment for advanced gastrointestinal stromal tumor (GIST), a type of tumor that originates in the gastrointestinal tract. Qinlock is indicated for adult patients who have received prior treatment with three or more kinase inhibitor therapies, including imatinib. Each year, approximately 4,000 to 6,000 adults in the United States are diagnosed with a GIST. GISTs arise when abnormal cells form in the tissues of the gastrointestinal tract. GISTs most commonly occur in the stomach, small intestine, and large intestine but can start anywhere along the gastrointestinal tract.

FDA Approves First Treatment for a Form of Bladder Dysfunction in Pediatric Patients as Young as 2 Years of Age
The U.S. Food and Drug Administration granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older. VESIcare (solifenacin succinate) tablets were initially approved in 2004 for the treatment of overactive bladder in adults 18 years and older.

FDA Approves Only Drug in U.S. to Treat Severe Malaria
The U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen. Prior to this approval, IV artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the U.S. Centers for Disease Control and Prevention (CDC) to provide IV artesunate to U.S. patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol. There has been no FDA-approved drug for treatment of severe malaria in the United States since the marketing of quinine was discontinued by the manufacturer in March 2019.


Participate in Upcoming FDA Meetings

The FDA, like other government agencies, is taking the necessary steps to ensure the agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are canceling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Where possible, the agency will leverage technology to host meetings allowing for remote participation. 

Visit FDA Meetings, Conferences and Workshops to find out about available meetings.

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