July 2021 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Women’s Health Colleagues,
In honor of Fibroid Awareness Month, OWH is working to bring broader awareness to this common yet often under discussed health condition. Uterine fibroids grow in and around the wall of the uterus and are the most common non-cancerous tumors in women of childbearing age.
This week, we welcomed Dr. Erica Marsh, Associate Professor and Chief of the Division of Reproductive Endocrinology, and Infertility in the Department of OBGYN at the University of Michigan as our featured scientific seminar series speaker. Dr. Marsh presented a very informative seminar to FDA highlighting not only the severe physical outcomes, but also the serious emotional and psychosocial consequences that can impact women suffering with this health condition. This topic is of personal interest to staff within our Office and I invite you to read this month’s OWH Blog to learn about their personal journeys living with uterine fibroids.
Not all women living with fibroids experience symptoms. If you have fibroids, it is important for you to work with your healthcare provider to determine the follow-up and treatment plan that is right for you.
Sincerely,
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
CORONAVIRUS UPDATES
Below are links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.
- Joint CDC and FDA Statement on Vaccine Boosters
- FDA Revokes Emergency Use Authorizations for Certain Respirators and Decontamination Systems as Access to N95s Increases Nationwide
- FDA Updates the Public on its Ongoing Evaluation of Adverse Event Reports of Myocarditis & Pericarditis Following Vaccination with Moderna and Pfizer-BioNTech COVID-19 Vaccines
- Learn More About COVID-19 Vaccines From the FDA
- FDA Authorizes Drug for Treatment of COVID-19
- FDA Warns that Vapors from Alcohol-based Hand Sanitizers can have Side Effects
CALL TO ACTION
July is Fibroid Awareness Month, a time dedicated to raising awareness and support to the many women who are suffering from these benign tumors that grow in the uterus of women of childbearing age. While most fibroids may not cause symptoms, some common symptoms include abdominal pain, heavy bleeding, enlargement of the lower abdomen, frequent urination, complications with pregnancy, reproductive problems and more. If you are experiencing symptoms or have been diagnosed with uterine fibroids, educate yourself, be sure to discuss your treatment options with your health care provider and ensure that the treatment recommended is best for you. In our latest blog post, FDA Office of Women’s Health staff share their personal experiences dealing with fibroids and the importance of medical advancement within the fibroid space. Read more here.
WOMEN'S HEALTH HIGHLIGHTS
Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA® and AVEENO® Aerosol Sunscreen Products Due to the Presence of Benzene
Johnson & Johnson Consumer Inc. (JJCI) is voluntarily recalling all lots of five NEUTROGENA® and AVEENO® aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products. Consumers should stop using the affected products and follow the instructions set forth in the announcement.
FDA Releases Cyclospora Prevention, Response and Research Action Plan
As part of our ongoing efforts to combat foodborne illness and aligned with our New Era of Smarter Food Safety initiative, today, the U.S. Food and Drug Administration released the Cyclospora Prevention, Response and Research Action Plan. Modeled after our Leafy Greens Shiga toxin-producing E. coli (STEC) Action Plan, the plan focuses on improving prevention, enhancing response activities and filling knowledge gaps in order to help prevent Cyclospora contamination of foods and to help prepare for responding to future outbreaks.
FDA Approves Component of Treatment Regimen for Most Common Childhood Cancer
FDA approved Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) as a component of a chemotherapy regimen to treat acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment. The only other FDA-approved drug for such patients with allergic reactions has been in global shortage for years.
Certain Philips Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks - FDA Safety Communication
FDA) issued a safety communication to alert people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks.
FDA’s Budget: Maternal and Infant Health and Nutrition
Nutrition during pregnancy and in early childhood is critically important in supporting the health and wellbeing of mothers and their children. The U.S. Food and Drug Administration’s food and nutrition programs are well-positioned to make progress in maternal and infant health and nutrition this year, and will invest across the centers and offices involved in its foods program to make improvements in key areas related to food safety and nutrition.
FDA Encourages Inclusion of Patients with Incurable Cancers in Oncology Clinical Trials Regardless of Prior Therapies
FDA issued a draft guidance encouraging industry to include patients with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in cancer clinical trials, regardless of whether they have received existing alternative treatment options. Historically, many clinical trials have required that participating patients previously received multiple therapies.
The FDA believes patients with incurable cancers, if provided adequate information to make an informed decision, should be eligible to participate in oncology clinical trials. If there is no scientific rationale for excluding these patients, then clinical trial eligibility criteria should be broadened to include these patients, with appropriate informed consent.
What Does FDA Regulate?
Do you know how many of the products you use every day are regulated by the FDA? About 20 cents of every dollar you spend is on a product regulated by the FDA.
FDA Approves First Oral Blood Thinning Medication for Children
FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa oral pellets to prevent recurrent clots among patients 3 months to less than 12 years old who completed treatment for their first venous thromboembolism.
FDA Approves a Nasal Antihistamine for Nonprescription Use
FDA approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch. The FDA approved Astepro (azelastine hydrochloride nasal spray, 0.15%) for seasonal and perennial allergic rhinitis—commonly known as allergies—for adults and children six years of age and older.
Safe Use of Flea and Tick Products in Pets
Fleas and ticks can cause serious health problems in your pets. The products come in a number of forms, and it's important that you know how to use them properly--and safely.
Philips Issues a Recall Notification to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain Sleep and Respiratory Care Devices
Philips decided to voluntarily issue a recall notification to inform patients and customers of potential impacts on patient health and clinical use related to this issue.
Should You Put Sunscreen on Infants?
When you go outdoors with your infant, whether for a quick stroll in the park or a day at the beach, it’s important to keep your little one out of the sun. But should you put sunscreen on your baby to protect them from the sun’s bright rays? Not usually.
Your infant’s sensitive skin is vulnerable to serious burns. But sunscreen isn’t the answer, according to the U.S. Food and Drug Administration. That’s because infants are at greater risk than adults of sunscreen side effects, such as a rash.
Pregnancy Registry
Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy.
Learn more about pregnancy registries today!
Participate in Upcoming FDA Meetings
- FDA Public Workshop: 6th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop, July 21-23, 2021
- FDA Oncology Center of Excellence Presents: Conversation on Cancer: Advancing Equity in Asian American and Pacific Islander (AAPI) Communities: Racism and Injustice, July 29, 2021
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.