November 2021 Office of Women's Health e-Update
Message from the Associate Commissioner
Diabetes is a chronic health condition that can lead to serious health complications over time. There are millions of women and men living with diabetes in the United States. However, diabetes can affect women differently. We are pleased to share our new OWH video which focuses on women and diabetes. Through this video, we hope to raise awareness about different types of diabetes, provide information about how diabetes impacts women, and share the unique experiences of women affected by this medical condition.
I also invite you to view and share our diabetes related resources on insulin and other medications used in the management of diabetes.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
Below are links to specific COVID-19 topics and the latest vaccine fact sheets, with a full list of the latest COVID-19 information from the FDA here.
- FDA Updates Test Policies to Help to Ensure Accuracy and Reliability of Tests and Increase Access to At-Home Tests
- FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age
- FDA Takes Additional Actions on the Use of a Booster Dose for COVID-19 Vaccines
CALL TO ACTION
November is Native American Heritage Month when diverse cultures, traditions, histories, and the important contributions of Native people are honored and celebrated. Our office has developed resources on health topics pertinent to Native women such as pregnancy, menopause, healthy aging and caregiving. We invite you to download or order our free health education publications for yourself and to share with your community.
WOMEN'S HEALTH HIGHLIGHTS
FDA Pharmacists Help You Use Medicines Safely
Whether at your local pharmacy or the U.S. Food and Drug Administration, pharmacists help patients achieve the best possible outcome when taking drugs. They can help people take their medicine properly and continue to take it for as long as recommended. Pharmacists are experts at interpreting information for patients. Have a question about your medicine? FDA’s Division of Drug Information can answer it.
What to Know About Breast Implants
FDA approved implants for increasing breast size, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. The FDA also approved breast implants to correct or improve the result of a previous surgery. Get the latest information on breast implants to help you make an informed decision about whether or not to use breast implants.
Out of an Abundance of Caution MaryRuth's Announces Voluntary Recall of Two Lots of Its Liquid Probiotic for Infants Because of the Potential for Contamination with Pseudomonas Aeruginosa
MaryRuth’s, a leading omni-channel health and wellness brand that offers vitamins, minerals, and supplements for the entire family, announced that, out of an abundance of caution, it is voluntarily recalling two lots of its liquid probiotic for infants (1oz) due to the possibility of contamination by Pseudomonas aeruginosa. Pseudomonas aeruginosa is a microorganism found in the environment that, if ingested, can cause infection in immunocompromised individuals or, rarely, in very young infants. P. aeruginosa infections in immunocompromised infants are generally limited to hospital settings. In such settings, there is the chance that the infant’s immature gut will not be able to prevent P. aeruginosa from gaining access to the blood, and from there it can disseminate elsewhere in the body, resulting in the possibility of serious adverse health consequences.
Updates on Philips Respironics CPAP, BiPAP, and Ventilator Recall
FDA provides an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. Ensuring patients and providers have the most up-to-date information regarding the recall of these critical devices is a top priority for the FDA.
FDA Launches Its First Video Focused on Patient Cybersecurity Best Practices #BeCyberSmart
Cyber Vitals: Information for Patients' Medical Device Health, offers practical steps patients can take to protect their device and personal information.
As medical devices are more connected, devices may be exposed to cybersecurity risks. The U.S. Food and Drug Administration (FDA) encourages patients to protect their personal information, monitor for unusual symptoms or behaviors of their device, and get a device check-up from their health care provider or the device manufacturer.
FDA Warns that Getting Alcohol-Based Hand Sanitizer in the Eyes Can Cause Serious Injury
FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure to hand sanitizer has been reported in all age groups; however, it has occurred most often in children. Such eye injuries have become much more frequent, likely due to the marked increase in the use of alcohol-based hand sanitizer during the COVID-19 pandemic.
Dental Implants Benefits and Risks
Dental implants are medical devices surgically implanted into the jaw to restore a person's ability to chew or their appearance. They provide support for artificial (fake) teeth, such as crowns, bridges, or dentures. A person considering dental implants should discuss with their dental provider possible treatment options, and the benefits and risks of the available treatments.
FDA provides information on FDA.gov to help people understand the benefits and risks of dental implants.
Tips from the FDA to Safely Treat Your Child’s Cough and Cold
Cough or cold medicine will not change the natural course of a cold or make it go away faster. In addition, some cough and cold medicines can have serious side effects, such as slowed breathing, which can be life-threatening, especially in infants and young children.
For those reasons, it’s important to know when your child needs medication, which treatments are recommended, and when to do without medicine.
FDA Strengthens Safety Requirements and Updates Study Results for Breast Implants
The FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions.
First, the agency issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions. Additionally, the agency has approved new labeling for all legally marketed breast implants that includes a boxed warning, a patient decision checklist, updated silicone gel-filled breast implant rupture screening recommendations, a device description with a list of specific materials used in the device and a patient device card. Finally, the FDA released updated information on the status of breast implant manufacturer post-approval studies. These actions will help patients understand the risks and benefits of breast implants and make more informed decisions about their health.
Endometrial Ablation for Heavy Menstrual Bleeding
FDA is providing resources on. FDA.gov to help inform the public, including individuals considering endometrial ablation, about the benefits and risks of the procedure. Endometrial ablation is a minimally invasive surgical procedure used to treat heavy menstrual bleeding (periods). The procedure works by ablating (destroying) the tissue in the lining of the uterus, which is called the endometrium. Because the endometrium is the tissue that causes bleeding, destroying this tissue may reduce menstrual bleeding to normal or lighter levels.
FDA Permits Marketing of New Oral Tobacco Products through Premarket Tobacco Product Application Pathway
FDA announced it has authorized the marketing of four new oral tobacco products manufactured by U.S. Smokeless Tobacco Company LLC under the brand name of Verve. Based on the FDA’s comprehensive review of available scientific evidence in the company’s premarket tobacco product applications (PMTAs), the agency determined the marketing of these products would be consistent with the statutory standard, “appropriate for the protection of the public health.”
FDA Issues Landmark Proposal to Improve Access to Hearing Aid Technology for Millions of Americans
The FDA issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids.
Hearing Aids and Personal Sound Amplification Products: What to Know
Hearing aid technology keeps evolving, which means there's a growing variety of styles and features to consider. Learn about hearing aids, personal sound amplification products, and the proposed change to how you can get hearing aids
FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
The FDA approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be substituted for), its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions.
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
- Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC), November 18-19, 2021
- Webinar on Proposed Rule for Establishing Over-the-Counter Hearing Aids and Draft Guidance for Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, December 7, 2021
- Conversation on Cancer: “50 Years and Counting: Engaging the Generations on Future Cancer Equity Opportunities,” December 13, 2021
- OTC Monograph Reform: OTC Sunscreen Drugs, December 15, 2021
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.