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January-February 2020 Office of Women's Health e-Update

Four women wearing red shirts

Message from the Associate Commissioner

Dear Women’s Health Colleagues,

It’s American Heart Month, and we are excited to share our new heart health educational video. This video was developed to help spread the word about women and heart health. Given heart disease is the leading cause of death for women in the United States, we sought to find out what women know about this topic. We learned that not all women are aware that heart disease symptoms in women can differ from those in men. This educational video is part of our new KNOWH the Difference initiative, which focuses on sharing important knowledge and news on women’s health (KNOWH). Additional details can be found in the Call to Action section below. I also invite you to learn about OWH research and extramural funding opportunities here, as we continue to support scientific research to advance women’s health.

Sincerely,

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

Women's Health Highlights

FDA approves first drug for treatment of peanut allergy for children
The U.S. Food and Drug Administration approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Treatment with Palforzia may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older. Those who take Palforzia must continue to avoid peanuts in their diets.

FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data
The U.S. Food and Drug Administration announced the launch of an interactive database that will offer a wealth of critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program. This launch is an important step in our ongoing commitment to address the global HIV epidemic and is consistent with our efforts to modernize and improve access to information and unleash the power of data.

FDA approves first treatment for thyroid eye disease
The U.S. Food and Drug Administration (FDA) approved Tepezza (teprotumumab-trbw) for the treatment of adults with thyroid eye disease, a rare condition where the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards (proptosis). The approval represents the first drug approved for the treatment of thyroid eye disease.

Shedding more light on sunscreen absorption
Even on cold, cloudy winter days, sunscreen safety remains a top priority at the U.S. Food and Drug Administration, as well it should since sunscreens are recommended for year-round use. The FDA’s newly-published research in the Journal of the American Medical Association (JAMA) provides much-needed additional information about the absorption of the active ingredients in sunscreens into the body’s bloodstream after they are applied to the skin. It’s an important follow-up study to prior research, published in JAMA in May 2019, that showed when certain sunscreens were used at their maximal recommended use (according to the product’s label), their active ingredients were absorbed through the skin and into the body. 

FDA expands youth e-cigarette prevention campaign to include stories from teenagers addicted to nicotine
The U.S. Food and Drug Administration’s “The Real Cost” Youth E-Cigarette Prevention Campaign will release videos featuring teenagers sharing cautionary tales about their e-cigarette addiction. The campaign will include a series of four videos called “My Vaping Mistake” with teenagers describing the physical and emotional effects of vaping addiction. The videos will be released on youth-focused channels and amplified on social media throughout the year.

FDA provides updates on discontinuation of Essure and ongoing postmarket activities
As of December 31, 2019, all unused Essure devices should have been returned to Bayer so that they are no longer available for implantation. Women who have been using Essure successfully to prevent pregnancy can and should continue to do so. Postmarket safety monitoring for women who have Essure implanted remains a top priority for the agency, and today we are announcing that enrollment in Bayer’s required postmarket surveillance study has ended.

FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint
Amid the epidemic levels of youth use of e-cigarettes and the popularity of certain products among children, the U.S. Food and Drug Administration issued a policy prioritizing enforcement against certain unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions.

FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors
The U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach or small intestine – harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes GIST that harbors a PDGFRA D842V mutation, which is the most common exon 18 mutation. Ayvakit is a kinase inhibitor, meaning it blocks a type of enzyme called a kinase and helps keeps the cancer cells from growing.

FDA provides additional information about requirements for dual column labeling, serving sizes on Nutrition Facts label
The U.S. Food and Drug Administration is issuing a final guidance to help manufacturers of packaged foods comply with the FDA’s updated Nutrition Facts labeling regulations. The final guidance addresses serving sizes of foods, including single-serving foods and other foods that can reasonably be consumed at one eating occasion and require dual column labeling.

FDA approves first generics of Eliquis
The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. Additionally, apixaban is indicated for the treatment of DVT and PE and for the reduction in the risk of recurrent DVT and PE following initial therapy.

FDA approves new treatment for adults with migraine
The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
The U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a human epidermal growth factor receptor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, meaning that the drug targets the changes in HER2 that help the cancer grow, divide and spread, and is linked to a topoisomerise inhibitor, which is a chemical compound that is toxic to cancer cells.

Call To Action

Video screenshot: Getting a Beat On What Women Know About Heart Health

Heart disease is the leading cause of death for women in the United States. Today, the Office of Women’s Health released a new video called “Getting A Beat On What Women Know About Heart Health”. We sought to find out what women know about heart disease and provide them with tips to improve their heart health. Help us raise awareness about women and heart disease by sharing the video with your network and communities throughout February and beyond. Watch the video here and get tips to help you make good decisions about your heart health. Please join us in our promotional efforts this month by sharing the posts and video content on our social media channels and the other heart health resources we have available.

We also recognized National Birth Defects Prevention Month. While not all birth defects can be prevented, you can increase your chances of having a healthy baby by managing your health conditions and by adopting healthy behaviors before and during pregnancy. Learn more about medicine and pregnancy, food safety, x-rays and ultrasounds and how to sign up for a Pregnancy Exposure Registry if you are taking medicines during pregnancy. We shared these resources in a Twitter chat hosted by March of Dimes, #Best4YouBest4Baby, in case you missed the discussion. 

Meetings

Participate in Upcoming FDA Meetings

Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc
February 04, 2020

FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials
February 13, 2020

Evolving Role of Artificial Intelligence in Radiological Imaging
February 25-26, 2020

Facilitating End-to-End Development of Individualized Therapeutics
March 03, 2020

Patient-Focused Drug Development for Stimulant Use Disorder
March 10, 2020

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