August 2021 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Women’s Health Colleagues,
Curious about the benefits of breastfeeding? Wondering how to store breast milk? In recognition of National Breastfeeding Month, we invite you to get the facts about breastfeeding by reading OWH’s August Knowledge and News on Women's Health blog where we answer questions on Best Practices for Safe and Healthy Breastfeeding.
Over the years, FDA has been actively engaged in efforts to expand our understanding of the safe use of medications in pregnancy and during breastfeeding. We recognize this is critical for informed decision-making. Learn about our Agency's broad efforts to advance a paradigm shift towards inclusion of pregnant and breastfeeding participants in clinical research in FDA’s recent Voices article.
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.
- 5 Things You Need to Know about the COVID-19 Vaccine for Adolescents 12 through 17
- FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals
- Pfizer-BioNTech COVID-19 Vaccine
- Moderna COVID-19 Vaccine
- Janssen COVID-19 Vaccine
- FDA Formally Accepts Pfizer’s Priority Review Designation for the Biologics License Application (BLA) for their mRNA Vaccine to Prevent COVID-19 in Individuals 16 Years of age and Older
CALL TO ACTION
This National Breastfeeding Month (NBM), the FDA Office of Women’s Health (OWH) celebrates all pregnant and breastfeeding moms. We encourage you and your loved ones to #KNOWHmore about the benefits of breastfeeding, best practices for safely handling your breast milk, medication safety, and more. Read our latest blog post for answers to commonly asked questions and valuable resources to support your breastfeeding decisions for you and your baby.
WOMEN'S HEALTH HIGHLIGHTS
FDA Grants First of its Kind Indication for Chronic Sleep Disorder Treatment
FDA approved a new indication for Xywav for idiopathic hypersomnia (IH) in adults. IH is an uncommon chronic sleep disorder that causes people to be excessively sleepy during the day even after a good night's sleep. Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution is already approved for the treatment of cataplexy or excessive daytime sleepiness in patients seven years or older with narcolepsy.
Able Groupe Recalling Products Labeled as Infant Formula Formulas Have Insufficient Iron Levels as Per Requirements for Infant Formula in The U.S., and Products Do Not Meet Other FDA Requirements
Able Groupe announced it is recalling certain products used as infant formulas. The recalled products are infant formulas (i.e., products intended as a complete or partial substitute for human milk for children 12 months old and younger), but the required pre-market notifications for these new infant formulas have not been submitted to the FDA.
FDA Approves New Treatment for Pompe Disease
The U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease. Patients with Pompe disease have an enzyme deficiency that leads to the accumulation of a complex sugar, called glycogen, in skeletal and heart muscles, which cause muscle weakness and premature death from respiratory or heart failure. Normally, glycogen—the stored form of glucose—breaks down to release glucose into the bloodstream to be used as fuel for the cells.
FDA Participates in New ‘Collaborative Communities’ to Address Emerging Challenges in Medical Devices
FDA announced participation in several new collaborative communities aimed at addressing challenges in patient health care. Collaborative communities are a continuing forum where private and public sector representatives of the community work together on medical device challenges to achieve common objectives and outcomes.
Is Rinsing Your Sinuses with Neti Pots Safe?
Little teapots with long spouts — commonly called neti pots — and other nasal irrigation devices have become a fixture in many homes to flush out clogged nasal passages and help people breathe easier. Nasal irrigation devices are usually safe and effective when used and cleaned properly. Get recommendations from the U.S. Food and Drug Administration (FDA) on how to use nasal irrigation devices safely, including what type of water to use and tips for use with children.
Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
FDA has posted answers to frequently asked questions related to Philips Respironics’ recent voluntary recall of certain CPAP, BiPAP, and ventilators due to potential health risks.
My Dog Has Cancer: What Do I Need to Know?
If your dog is a member of your family, and your vet says your pet has cancer, you are understandably anxious. What are some key questions you should ask?
FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes
FDA approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with (can be substituted for), its reference product Lantus (insulin glargine), a long-acting insulin analog. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S. for the treatment of diabetes. Approval of these insulin products can provide patients with additional safe, high-quality and potentially cost-effective options for treating diabetes.
Hyperbaric Oxygen Therapy: Get the Facts
FDA has cleared the use of Hyperbaric Oxygen Therapy (HBOT) for the treatment of several conditions. The FDA is aware there are some hyperbaric oxygen treatment centers promoting hyperbaric oxygen chambers for uses that have not been cleared or approved by the FDA, such as treatment of cancer, Lyme disease, autism, or Alzheimer’s disease.
Check with your health care provider before using HBOT to make sure you are pursuing the most appropriate care. If your health care provider recommends HBOT, the FDA advises you get the treatment at a hospital or facility that has been inspected and is accredited by the Undersea and Hyperbaric Medical Society.
FDA approves pembrolizumab for high-risk early-stage triple-negative breast cancer
FDA approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
FDA grants regular approval to pembrolizumab and lenvatinib for advanced endometrial carcinoma
FDA approved pembrolizumab (Keytruda, Merck) in combination with lenvatinib (Lenvima, Eisai) for patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
Accidental Exposures to Fentanyl Patches Continue to Be Deadly to Children
Accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, an opioid pain reliever. The FDA urges parents and caregivers to take precautions and make sure these patches are stored, used, and disposed of properly.
FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy; Still Advises Most Pregnant Patients Should Stop Taking Statins
FDA is requesting removal of its strongest warning against using cholesterol-lowering statin medicines in pregnant patients. Despite the change, most patients should stop statins once they learn they are pregnant. We have conducted a comprehensive review of all available data and are requesting that statin manufacturers make this change to the prescribing information as part of FDA’s ongoing effort to update the pregnancy and breastfeeding information for all prescription medicines.
Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content
Pfizer is recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.
Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines
Concerned about the dearth of information available on the safety and effectiveness of medical products for pregnant and breastfeeding women, the U.S. Food and Drug Administration and many of its regulatory counterparts around the world say it is time to address inadequacies in research through a paradigm shift in the approach to studying medical products in these populations.
Nitrite “Poppers”: Inhaling or Ingesting may Result in Severe Injury or Death
Health care providers are reporting increases in deaths and hospitalizations related to intentional ingestion or inhalation of nitrite products for recreational use, including sexual experience enhancement.
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!
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