October 2020 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Women’s Health Colleagues,
Mammograms can help save lives. October is Breast Cancer Awareness Month and serves as a reminder to speak to your healthcare provider about the best time to schedule a mammography screening. Facilities that offer mammograms in the U.S. must be certified and meet standards set by the FDA. You can search for a certified facility near you here. I encourage you to learn about mammography facts and other resources we have available by visiting our mammography webpage. We hope you will utilize and share these resources with your community.
FDA is committed to supporting women with breast cancer. Historically, premenopausal women have been excluded from clinical trials that studied the efficacy of hormonal drugs for the treatment of hormone positive breast cancer, largely due to concerns about potential differences in how these products would behave. This exclusion resulted in delays in availability of these therapies for premenopausal women. Last week, FDA issued draft guidance encouraging the inclusion of premenopausal women in breast cancer clinical trials that investigate the efficacy of hormonal products. Additional details on this FDA In Brief announcement can be found here.
We also invite you to register for our upcoming scientific conference exploring potential sex and gender differences in use and responses to cannabidiol (CBD) and other cannabinoids scheduled for November 19, 2020. Learn more about this upcoming meeting here.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
Below are additional links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.
- FDA Authorizes First Point-of-Care Antibody Test for COVID-19
- FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
WOMEN'S HEALTH HIGHLIGHTS
FDA Warns Dietary Supplement Companies Illegally Selling Products Containing Cesium Chloride
The U.S. Food and Drug Administration today posted five warning letters issued to companies marketing dietary supplements containing cesium chloride. In a February 2020 public health alert, the FDA warned consumers and health care professionals to avoid using dietary supplements containing cesium salts, primarily cesium chloride. In July 2018, the FDA alerted health care professionals of significant safety risks associated with cesium chloride in compounded drugs. Cesium chloride is sometimes promoted as an alternative treatment for cancer; however, no cesium-chloride-containing products have been approved by the FDA to treat cancer or any other disease.
Do Not Use: Black Salve is Dangerous and Called by Many Names
You may have seen websites selling certain salves or creams (commonly known as “black salve”) claiming to treat or cure cancer, boils, moles and skin tags (benign, or non-cancerous, growths of the skin). These claims are false. Salve products containing corrosive ingredients, including black salve, are dangerous and are not approved by the U.S. Food and Drug Administration (FDA) to treat or cure any skin condition, particularly not skin cancer. Specifically, the FDA is warning consumers not to use any salves or other topically applied products that list any of the following potentially dangerous ingredients: sanguinarine, Sanguinaria canadensis, or bloodroot, alone or in combination with zinc chloride.
Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)
Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.
CDER Proposes Withdrawal of Approval for Makena
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required postmarket study failed to verify clinical benefit and we have concluded that the available evidence does not show Makena is effective for its approved use.
The Facts on Tampons—and How to Use Them Safely
Tampons are regulated by the U.S. Food and Drug Administration as medical devices. If you use tampons during your period (or menstruation), it’s important to know how to use them safely. Consider this important information from the U.S. Food and Drug Administration (FDA)—and please share this information with other people who may use these products.
It’s a Good Time to Get Your Flu Vaccine
While the United States remains focused on the COVID-19 pandemic, we need to also be aware of flu season as we approach winter. Flu viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu.
FDA Issues Final Guidance for Certain Labeling Recommendations for Breast Implants
The U.S. Food and Drug Administration issued the final guidance, “Breast Implants - Certain Labeling Recommendations to Improve Patient Communication,” as part of the agency’s effort to help improve the information available to patients and health care professionals about the risks of breast implants. The draft guidance of this document was issued in 2019.
Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine
FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. FDA is aware of news reports of teenagers ending up in emergency rooms or dying after participating in the “Benadryl Challenge” encouraged in videos posted on the social media application TikTok. FDA is investigating these reports and conducting a review to determine if additional cases have been reported. FDA will update the public once the review is complete or if there is more information to share.
FDA Issues Recommendations for Certain High-Risk Groups Regarding Mercury-Containing Dental Amalgam
The FDA is issuing updated recommendations concerning dental amalgam and potential risks to certain high-risk individuals that may be associated with these mercury-containing fillings used to restore the missing structure and surfaces of a decayed tooth.
The FDA has found that certain groups may be at greater risk for potential harmful health effects of mercury vapor released from the device. As a result, the agency is recommending certain high-risk groups avoid getting dental amalgam whenever possible and appropriate.
Metformin Hydrochloride for Extended-Release Oral Suspension by Sun Pharmaceutical Industries: Recall - Due to N-Nitrosodimethylamine Content Above the Acceptable Daily Intake Limit
RIOMET ER™ (metformin hydrochloride for extended-release oral suspension) is a prescription oral medication indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration.
FDA Requiring Labeling Changes for Benzodiazepines
The U.S. Food and Drug Administration announced in a Drug Safety Communication that it is requiring an update to the Boxed Warning, the agency’s most prominent safety warning, and requiring class-wide labeling changes for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions to help improve their safe use. Most benzodiazepines are recommended for use for periods of weeks or months. Benzodiazepines are important approved treatment options for generalized anxiety disorder, insomnia, seizures, social phobia and panic disorder. They are also used as premedication before some medical procedures.
FDA Warns Website Operators Illegally Selling Opioids to Consumers
The U.S. Food and Drug Administration has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act. Misbranded opioids include those offered for sale without a prescription, as well as opioids that lack adequate directions for use. The opioids offered for sale include products such as tramadol and oxycodone. These are prescription drugs that have significant risks of addiction, abuse and misuse, which can lead to overdose and death, and should only be used under the supervision of a licensed health care provider. These warning letters are a continuation of the FDA’s commitment to take action against the illegal sale of opioids over the internet.
National Survey Shows Encouraging Decline in Overall Youth E-Cigarette Use, Concerning Uptick in Use of Disposable Products
The U.S. Food and Drug Administration, in partnership with the Centers for Disease Control and Prevention, released new data from the 2020 National Youth Tobacco Survey (NYTS), which show 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019. After two years of disturbing increases in youth e-cigarette use, we are encouraged by the overall significant decline reported in 2020. This is good news; however, the FDA remains very concerned about the 3.6 million U.S. youth who currently use e-cigarettes and we acknowledge there is work that still needs to be done to curb youth use.
RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® with Current Expiry Due to Sub Potency
RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing of samples from six (6) lots by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4). Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent Nature-Throid® or WP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development.
FDA's Food and Cosmetics Information Center Answers Your Questions
Getting answers to your questions about food and cosmetic safety can be difficult. But it doesn't have to be. FDA's Food and Cosmetics Information Center is available to answer your questions about nutrition and the safety and labeling of food, dietary supplements and cosmetics. Many of those answers pertain to the coronavirus pandemic.
The Protein Shoppe, LLC Issues Voluntary Nationwide Recall of the “Red- E” Male Enhancement Tablet [RJ1] [OWH2] Due to the Presence of Undeclared Sildenafil
The Protein Shoppe, LLC is voluntarily recalling all lots of “Red-E” (Male Enhancement tablet) to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, a Phosphodiesterase-5 (PDE-5) inhibitor which is the active ingredient in an FDA approved drug used in the treatment of erectile dysfunction. The presence of sildenafil in Red-E renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients
The U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 diabetes. The 770G System is a first-of-a-kind device for patients aged 2 to 6 years. It is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population.
FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma
The U.S. Food and Drug Administration provided an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and systemic signs and symptoms referred to by patients as breast implant illness (BII), which some patients report after receiving breast implants.
CALL TO ACTION
Staying healthy can be a challenge. Now more than ever, we need to ensure that we are making the most of this new reality by adopting healthy habits and behaviors. There's no quick fix and women often spend so much time helping others that they don't take time for themselves. Staying physically and mentally active, getting health screenings, managing health conditions, and keeping in touch with your healthcare provider are all things you can do to stay healthy and contribute to a more productive and meaningful life.
It’s OK to take time for yourself and prioritize your wellness. No matter your age, health plays a big role in you making the most of every moment. The FDA Office of Women’s Health has resources to help empower you on your journey to a healthier you!
Pregnancy Exposure Registries
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
The FDA Office of Women’s Health is hosting a public meeting to discuss potential sex (biological) and gender (psychosocial) differences in use and responses to cannabidiol (CBD) and other cannabinoids. Researchers, educators, clinicians, and patients may benefit from attending this multidisciplinary scientific conference on CBD and other cannabinoids. Click here to register for this conference.
UPCOMING FDA MEETINGS
Sentinel Initiative Public Training on Maternal Health and Pregnancy, November 2, 2020
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.