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August 2019 Office of Women's Health e-Update

photo of mother holding infant with breast milk bottles in the background

Message from the Acting Associate Commissioner

Dear Women’s Health Colleagues,

August marks National Breastfeeding Month! Many women who are breastfeeding use a breast pump to express and store their breast milk. FDA has resources available that provide information on how to safely use breast pumps and store breast milk. This includes Breast Pumps: Quick Facts as well as important Tips on How to Choose and Clean Breast Pumps. In addition to the information available on our website, we are providing general breastfeeding tips on our social media channels throughout the month.

We are are also resharing information we recently sent you about the action issued by FDA requesting Allergan to recall specific textured breast implants. I hope that you will share our safety messages, opportunities to participate in upcoming public meetings and other highlights provided in our monthly update with your network.

Kaveeta Vasisht, M.D., Pharm.D.
Acting Associate Commissioner for Women's Health

Women's Health Highlights

FDA takes action to protect patients from risk of certain textured breast implants; requests Allergan voluntarily recall certain breast implants and tissue expanders from market
The U.S. Food and Drug Administration took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. The recall helps ensure that unused products are removed from suppliers and doctors’ offices. The agency also issued a safety communication for patients with breast implants, patients considering breast implants and their health care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts. The safety communication also lists information about all models and style numbers included in the recall.

FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections
The U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). “The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” said Ed Cox, M.D., M.P.H., director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.” Recarbrio is a three-drug combination injection containing imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor.

FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign
The U.S. Food and Drug Administration is announcing the launch of its first e-cigarette prevention TV ads educating kids about the dangers of e-cigarette use. The FDA also plans to provide new posters for high schools and educational materials for middle schools across the U.S. as part of “The Real Cost” Youth E-Cigarette Prevention Campaign. The public education effort was first launched in September 2018 with hard-hitting advertising on digital and social media sites, as well as posters with e-cigarette prevention messages displayed in high schools across the nation, targeting nearly 10.7 million youth, aged 12-17, who have used e-cigarettes or are open to trying them. As the campaign’s one-year anniversary approaches, the new TV ads and school resources are designed to continue to engage youth with important public health messages about the risks of e-cigarette use.

FDA approves first therapy for rare joint tumor 
The U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. “TGCT can cause debilitating symptoms for patients such as pain, stiffness and limitation of movement. The tumor can significantly affect a patient’s quality of life and cause severe disability,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Surgery is the primary treatment option, but some patients are not eligible for surgery, and tumors can recur, even after the procedure. The approval is the first FDA-approved therapy to treat this rare disease.”

FDA approves first treatment for severe hypoglycemia that can be administered without an injection
The U.S. Food and Drug Administration approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. Severe hypoglycemia occurs when a patient’s blood sugar levels fall to a level where he or she becomes confused or unconscious or suffers from other symptoms that require assistance from another person to treat. Typically, severe hypoglycemia occurs in people with diabetes who are using insulin treatment. Baqsimi is approved to treat severe hypoglycemia in patients with diabetes ages four and older.

FDA clears new indications for existing Lyme disease tests that may help streamline diagnosis
The U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run concurrently or sequentially, rather than the current two-step process in which a separate protein test called a Western Blot must be run after the initial EIA test.

Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks
The Neonatal ConchaSmart Breathing Circuits are intended for neonatal and infant patients requiring mechanical ventilation, positive pressure breathing assistance, or general medical gases. Teleflex is recalling the Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column due to complaints of cracks being observed, prior to use, on swivel wye adaptors, a part of the device. Cracks in the adapter may cause breathing distress because the gas may leak and not reach the patient. Breathing distress from insufficient oxygenation could result in serious adverse health consequences including death.

Some Medicines and Driving Don’t Mix
If you’re taking a medication, is it safe to drive? The U.S. Food and Drug Administration (FDA) advises you to make sure before operating any type of vehicle, whether a car, bus, train, plane, or boat. Although most medications won’t affect your ability to drive, some prescription and over-the-counter (OTC) drugs (also called nonprescription medicines) can have side effects and cause reactions that may make it unsafe to drive.

GE Healthcare, LLC Recalls Giraffe Infant Warmers and Panda i-Res Infant Warmers Due to Bedside Panels and Latch Areas Cracking or Breaking
Infant radiant warmers provide infrared heat in a controlled manner to infants who are unable to maintain their body temperature on their own. Radiant heat from an infrared heat source is focused onto the bed to warm the infant. The primary users of the device are infants in a hospital setting. GE Healthcare is recalling the Giraffe and Panda i-Res Infant Warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle (see figures below). If an infant comes in contact with a bedside panel with a cracked or broken latch, the panel can disengage and fall open, no longer protecting the infant from falling from the warmer.

Call To Action 

August is National Breastfeeding Month and we’ll be sharing general tips on our social media channels throughout the month. To learn more about breast pumps and breastfeeding, or for other resources on pregnancy and being a new mom, visit: www.fda.gov/pregnancy. August is also back-to-school season and whether you are a college student, parent, or health care professional, we’ve got resources for you!

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  • Learn more about 2019 FDA medical device recalls here


OWH Conference Exhibits

US Conference on AIDS
September 5-8, 2019; Washington, DC

Participate in Upcoming FDA Meetings

Developing Therapies for Primary Mitochondrial Diseases: Bridging the Gaps
September 6, 2019

Patient Engagement Advisory Committee Meeting Announcement
September 10, 2019           

Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement
September 13, 2019

Identification and Use of Biomarkers to Advance Development of Preventive Vaccines; Public Workshop
September 16-17, 2019

Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing
September 17, 2019

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