CIENCIASMEDICASNEWS: FDA Updates for Health Professionals- February 7, 2018

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February 07, 2018

ANNOUNCEMENTS

The agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse
Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health. However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of this product and how it works in the body

The recent National Toxicology Program draft report on radiofrequency energy exposure
One part of the Food and Drug Administration’s mission is to ensure the safety of electronic products that emit radiation, like televisions and cell phones. These types of products are part of Americans’ daily life and we take our duty to protect consumers with the utmost gravity. With cell phones, we have relied extensively on a myriad of scientific evidence developed over many years to help inform our regulatory thinking.

Ongoing efforts to mitigate impact of saline shortages during this flu season
As flu activity remains widespread across the U.S., the FDA continues to monitor this situation closely and in coordination with our colleagues at the U.S. Centers for Disease Control and Prevention. We’re continuing to take steps to help ensure that people with the flu have access to critical medical products, including antivirals, saline and other supportive care drugs and devices.

New steps to help prevent new addiction, curb abuse and overdose related to opioid products
The issue of opioid misuse and abuse remains one of my highest priorities and we believe it’s going to take carefully developed, sustained, and coordinated action by everyone involved to reduce the tide of opioid addiction and death afflicting our communities; while maintaining appropriate prescribing for patients in medical need. We recognize both the urgency and complexity of this crisis and are taking several steps today toward these goals.

FDA, USDA announce formal agreement to bolster coordination and collaboration
U.S. Agriculture Secretary Sonny Perdue and FDA Commissioner Scott Gottlieb, M.D. announced at the White House today a formal agreement aimed at making the oversight of food more efficient and effective by bolstering coordination between the two agencies. The formal agreement outlines efforts to increase interagency collaboration, efficiency and effectiveness on produce safety and biotechnology activities, while providing clarity to manufacturers

FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study
The FDA has a deep commitment to ensuring the responsible and humane care of animals when research involving animals is needed to fulfill the agency’s public health mission. The FDA also is fully committed to complying with the rules and guidance governing animal research.

FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims
FDA and FTC take action against companies illegally marketing unapproved products with claims to help with opioid addiction and withdrawal

DRUG SHORTAGES

PRODUCT APPROVALS & CLEARANCES

FDA approves new treatment for certain digestive tract cancers
The FDA approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult patients with somatostatin receptor-positive GEP-NETs.

For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed

PRODUCT SAFETY

Pentax Medical Duodenoscope Model ED-3490TK: Updated Design and Labeling Cleared
Pentax issued an Urgent Medical Device Correction and Removal notification informing customers of its voluntary recall of all ED-3490TK duodenoscopes in order to replace the forceps elevator mechanism, O-ring seal and distal end cap, and to update the Operation Manual to recommend annual maintenance.

FDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use
To foster safe use of the over-the counter (OTC) anti-diarrhea drug loperamide, FDA is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package.

Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs
In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the FDA to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act

Break Ventures/California Basics Recalls "Zero For Him" 150ct Lot#1710-638 Because of Possible Health Risk
Break Ventures/California Basics is recalling its Dietary Supplement “Zero for Him 150ct” Lot#1710-638 (the “Product”) because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall- Mislabeling
Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).

Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity
Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel

Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility
Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.

For important safety information on human drugs, medical devices, dietary supplements and more, or to report an adverse event or problem with a medical product, please visit MedWatch, The FDA Safety Information and Adverse Event Reporting Program.

UPCOMING MEETINGS

FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee. Other types of meetings listed may require prior registration and fees. Click on "more information" for details about each meeting.

Please visit FDA’s Advisory Committee webpage for more information. Please visit Meetings, Conferences, & Workshops for more information on other agency meetings.

FEBRUARY

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting (Feb 14)
The committees will be asked to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees will also be asked to discuss the abuse potential of this non-abuse-deterrent product and whether it should be approved.

Anesthetic and Analgesic Drug Products Advisory Committee Meeting (Feb 14-15)
The committee will discuss supplemental new drug application (sNDA) 022496/S-009, for EXPAREL (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia.

FDA-AACR-ASTRO Regulatory Science and Policy Workshop - Clinical Development of Drug-radiotherapy Combinations (Feb 22-23)
There is great interest among clinicians as well as regulatory authorities to address the lack of drug development for products intended specifically for use with radiation therapy. Emerging from the enthusiasm and momentum of a session at the AACR-sponsored Accelerating Anticancer Agent Development and Validation Workshop (May 3-5, 2017, Bethesda, Maryland), this two-day workshop will bring together regulatory agencies, industry, and academia to discuss the challenges in greater depth and come up with a path forward.

MARCH

Neurological Devices Panel of the Medical Devices Advisory Committee Meeting (Mar 1)
The committee will discuss, make recommendations, and advise FDA regarding the evaluation of clinical study data to support the safety and effectiveness of intracranial aneurysm treatment devices and factors that can affect clinical outcomes such as aneurysm morphology, size, and location in the neurovasculature. FDA is also convening this committee to seek expert opinion on the scientific and clinical considerations relating to the clinical trial design that may be relevant to the determination of safety and effectiveness for these devices.

IASLC-FDA Lung Cancer Neoadjuvant Meeting (Mar 1-2)
This initial meeting between the FDA, the IASLC, industry and investigators is designed to facilitate discussions regarding the standardization of endpoints in neoadjuvant lung cancer trials and to discuss how said endpoints can be validated by comparing novel endpoints to established time to event endpoints.

Risk Communication Advisory Committee Meeting Announcement (Mar 5)
The committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule.

Gastrointestinal Drugs Advisory Committee Meeting (Mar 8)
The committee will discuss supplemental new drug application (sNDA) 203214, supplement 18, XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response or intolerance to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor (TNF) inhibitor therapy.

Oncology Center of Excellence Listening Session; Public Meeting (Mar 15)
The purpose of the public meeting and the docket for comments is for stakeholders to provide recommendations to the Agency regarding FDA's OCE. Specifically, the Agency solicits comments regarding what stakeholders desire of the OCE in terms of structure, function, regulatory purview, and activity.

Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement (Mar 22)
Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH) submitted by BioMarin Pharmaceutical Inc.

Pediatric Advisory Committee Meeting (Mar 23)
Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. The Pediatric Advisory Committee will meet to discuss the following products: Center for Drug Evaluation and Research: BANZEL, INTUNIV, LEXAPRO
Center for Devices and Radiological Health: FLOURISH (HDE), ACTIVA (HDE), LIPOSORBER (HDE), IMPELLA RP SYSTEM (HDE)

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visitMedWatch, The FDA Safety Information and Adverse Event Reporting Program

Opportunities for Comment
The FederalRegister.gov website was developed to make it easier for citizens and communities to understand the regulatory process and to participate in Government decision-making. The Office of the Federal Register of the National Archives and Records Administration and the U.S. Government Publishing Office jointly administer the FederalRegister.gov website.

MedWatchLearn - Practice Reporting to FDA!
This web-based learning tool teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA.

Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information endruginfo@fda.hhs.gov.

FDA Expert Commentary and Interview Series on Medscape
As part of the continuing collaboration between FDA and Medscape, a series of interviews and commentaries are available to communicate important safety information to clinicians. Featuring FDA experts, these original commentaries cover a wide range of topics related to FDA's multi-faceted mission of protecting and promoting the public health by ensuring the safety and quality of medical products such as drugs, foods, and medical devices.

Cardiovascular and Endocrine Liaison Program
The Cardiovascular and Endocrine Liaison Program serves as a liaison between the FDA and the cardiovascular and endocrine health professional and patient communities. Discover how you or your organization can collaborate with FDA.

Medical Product Safety Network (Medsun)
Medsun improves FDA's understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The Medsun newsletter provides monthly updates about timely medical device issues that may impact patient safety.

FDA Basics
Each month, different Centers and Offices at FDA will host an online session where the public can ask questions to senior FDA officials about a specific topic or just listen in to learn more about FDA.

FDA Voice
FDA voice is the official blog from FDA's senior leadership and staff.