The Office of Women's Health e-Update highlights women's health initiatives, meetings, and regulatory safety information from the U.S. Food and Drug Administration (FDA). The e-Update is disseminated via email to the public.
Message from the Associate Commissioner
Dear Women’s Health Colleagues,
National Women’s Health Week 2021 is upon us and our theme for this year is Take Time to Care, TODAY! We encourage all women to prioritize their health now, and on a regular basis throughout the year. Our Office will be sharing an abundance of information and resources throughout the week on our blog and during our Twitter Video Chat, to be held this Tuesday, May 11 at 2p.m.ET. You can find more details on National Women’s Health Week and our upcoming Twitter Video Chat.
Last month, we informed you that the FDA and CDC lifted the pause on the Johnson & Johnson (Janssen) COVID-19 vaccine following a thorough safety review. At the time of the announcement, the Agencies confirmed that a total of 15 cases of blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS) occurred in women between the ages of 18 and 59 with a median age of 37 years. The available data suggest that the chance of blood clots and low platelets occurring is very low, and the FDA and CDC remain vigilant in continuing to investigate this risk. The Agencies concluded that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older. Learn more in our CORONAVIRUS UPDATES section below.
The FDA also announced a commitment towards issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars. Efforts to ban menthol cigarettes and flavored cigars build on previous flavor bans and mark significant steps to reduce addiction and youth experimentation, improve quitting, and address health disparities. Please take a moment to read the full announcement from the Agency in this month’s newsletter.
Thank you for your continued support.
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, with a full list of the latest COVID-19 information from the FDA here.
- Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations
- FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
- Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine
- FDA Continues Important Steps to Ensure Quality, Safety and Effectiveness of Authorized COVID-19 Vaccines
May’s Knowledge and News on Women blog post celebrates National Women’s Checkup Day during National Women’s Health Week. Our latest post outlines five tips to make sure your health is a priority today, and throughout the year. Due to the COVID-19 pandemic, many women put off routine health visits and screenings, but these appointments are vital to helping women maintain healthy lifestyles. National Women’s Checkup Day serves as an important reminder to make sure you plan your annual checkup with your healthcare provider. Read our blog to ensure you have the tips you need to take time to care for yourself, TODAY!
WOMEN'S HEALTH HIGHLIGHTS
Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Sub Potency
Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 below of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).
Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP 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 Approves Treatment for Chronic Kidney Disease - Approval is First to Cover Many Causes of Disease
The FDA approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.
FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose
The FDA announced approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products. Naloxone is a medicine that can be administered by individuals with or without medical training to help reduce opioid overdose deaths. If naloxone is administered quickly, it can counter the opioid overdose effects, usually within minutes. A higher dose of naloxone provides an additional option in the treatment of opioid overdoses.
FDA Takes Action for Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov
Being transparent about the results of completed clinical trials enables important advances in the development of medical products and helps ensure a safe, effective and efficient clinical research enterprise. Across all types of medical product trials, the FDA works with responsible parties to encourage compliance with the requirements to submit registration and summary results information to the ClinicalTrials.gov data bank, managed by the National Institutes of Health (NIH)/National Library of Medicine.
The FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously and we will continue to encourage voluntary compliance with these requirements. When necessary, the FDA will take appropriate actions to help ensure that required information is available on ClinicalTrials.gov as required by law and for the benefit of clinical trial participants and public health.
The FDA has determined that a responsible party who received a Pre-Notice of Noncompliance has not complied with its legal reporting obligations. The FDA has determined that a responsible party who received a Pre-Notice of Noncompliance has not complied with its legal reporting obligations. Accordingly, the FDA issued its first Notice of Noncompliance to Acceleron Pharma, Inc. (Acceleron) for failing to submit required summary results information to ClinicalTrials.gov.
FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers
The FDA announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the leading cause of preventable death in the U.S. The FDA is working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars; the authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave the agency. This decision is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important, previous actions that banned other flavored cigarettes in 2009.
FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients
The FDA authorized marketing of a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity—or hand, wrist and arm—disability.
FDA Approves Immunotherapy for Endometrial Cancer with Specific Biomarker
The FDA granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA inside the cell), as determined by an FDA-approved test.
Colorectal Cancer: What You Should Know About Screening
The evidence is clear - screening for colorectal cancer may save your life. Today, more and more people are choosing colorectal cancer screening. As a result, there is a steady decline in the number of older people getting and dying from colorectal cancer. Lower rates of smoking among Americans have also contributed to the decline in the past several years.
There are several FDA-reviewed and approved or cleared choices for colorectal cancer screening. Find out which one is best for you.
FDA Approves First Immunotherapy for Initial Treatment of Gastric Cancer
The FDA approved Opdivo (nivolumab), in combination with certain types of chemotherapy, for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.
“Today’s approval is the first treatment in more than a decade to show a survival benefit for patients with advanced or metastatic gastric cancer who are being treated for the first time,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
FDA Releases Action Plan for Reducing Exposure to Toxic Elements from Foods for Babies, Young Children
Protecting one of our most vulnerable populations, babies and young children, is among the U.S. Food and Drug Administration’s highest priorities. Last week, the agency announced a new action plan, Closer to Zero, that sets forth our approach to reducing exposure to toxic elements in foods commonly eaten by babies and young children to the lowest possible levels. Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time.
FDA Authorizes Marketing of First Device that Uses Artificial Intelligence to Help Detect Potential Signs of Colon Cancer
FDA authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy.
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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