November 2019 Office of Women's Health e-Update
Message from the Acting Associate Commissioner
Dear Women’s Health Colleagues,
This year marks 25 years since the establishment of the Office of Women’s Health (OWH) within the U.S. Food and Drug Administration (FDA).
Since 1994, OWH has worked to protect and advance the health of women through science, policy, education, and outreach while advocating for the inclusion of women in clinical trials. OWH has facilitated advancements in women’s health through work across FDA and with external stakeholders. Thanks to this work, women today are better informed and have access to safer products. Our research on women’s health and the development of health education resources enable women to make healthy choices for themselves and others at all stages of their lives. Current OWH initiatives, ranging from our compilation of pregnancy registries to funded projects on communication with older women about FDA-regulated products, reflect this commitment.
We also want to give thanks for our strong partnerships with our stakeholders. From collaborating with us on outreach campaigns to working with us on scientific and educational projects, we are grateful for all you help us do to protect and advance women’s health.
Kaveeta Vasisht, M.D., Pharm.D.
Acting Associate Commissioner for Women's Health
Women's Health Highlights
FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy
FDA is evaluating the results of a Danish study that concludes there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. We are also reviewing additional data and will communicate our final conclusions and recommendations when our review is complete.
Health care professionals should be aware that the Centers for Disease Control and Prevention guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur. Patients who are pregnant or actively trying to get pregnant should talk to their health care professionals about alternative treatment options for yeast infections.
FDA provides updates on ongoing postmarket activities for Essure device
“Even though the Essure device is no longer sold in the U.S., the FDA is committed to continuing to monitor the postmarket safety of the device for women who have the device implanted. Today, we are providing an update on our ongoing postmarket activities related to Essure, so that patients and health care professionals have up-to-date information on this device,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is also reminding health care professionals and facilities that before the end of this year, all Essure devices that have not been implanted should be returned to Bayer. We remain committed to collecting long-term safety information and ensuring that Bayer continues to meet its mandated postmarket study obligations beyond 2019. We’ll continue to communicate with patients and health care professionals about Essure as new information becomes available.”
FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease
The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.
Baby powder manufacturer voluntarily recalls products for asbestos
The U.S. Food and Drug Administration is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos. Consumers who have Johnson’s Baby Powder lot #22318RB should stop using it immediately and contact Johnson & Johnson for a refund. The FDA stands by the quality of its testing and results and is not aware of any adverse events relating to exposure to the lot of affected products.
FDA approves new treatment for patients with migraine
The U.S. Food and Drug Administration approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine.
FDA warns that biotin may interfere with lab tests
The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication to remind the public, health care providers, lab personnel, and lab test developers that biotin, often found in dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected. The FDA wants to make the public and health care providers aware about biotin interference with lab tests so that patients, physicians, and laboratories can work together to help prevent adverse events.
Medtronic recalls MiniMed insulin pumps for potential cybersecurity risks
People who have diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes. The pump includes a remote controller which is designed to communicate wirelessly with the pump to deliver a specific amount of insulin to the person with diabetes.
Medtronic is recalling the specified insulin pumps due to potential cybersecurity risks. An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump. This person could instruct the pump to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis, even death.
To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks.
FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations
The U.S. Food and Drug Administration authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. The Sentosa SQ HIV Genotyping Assay is the first HIV drug resistance assay that uses NGS technology that the FDA has authorized for marketing in the U.S.
FDA approves new breakthrough therapy for cystic fibrosis
The U.S. Food and Drug Administration approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is estimated to represent 90% of the cystic fibrosis population.
FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs
The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs as well as other drug products sold at Dollar Tree and Family Dollar stores.
FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance
The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.
FDA approves first contact lens indicated to slow the progression of nearsightedness in children
The U.S. Food and Drug Administration approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens is a single use, disposable, soft contact lens that is discarded at the end of each day, and is not intended to be worn overnight.
FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease
The U.S. Food and Drug Administration approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients, age 16 years and older.
Call To Action
For the past 25 years, the U.S. Food and Drug Administration's Office of Women’s Health has forged a pathway fostering and supporting advancements in the health of women through its work across the agency and with stakeholders. Learn more about FDA’s long-standing commitment and approach to women’s health. Follow along and share our celebratory graphics on Pinterest and Twitter with your family, friends, and community today!
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