December 16, 2015

ANNOUNCEMENTS

Navigating the New Clozapine REMS

On September 15th, 2015, the US Food and Drug Administration (FDA) approved a new, shared risk evaluation and mitigation strategy (REMS) for the atypical antipsychotic medication clozapine in order to help address ongoing concerns about the association between the drug and neutropenia. Mitchell Mathis, MD, Director of the Division of Psychiatry Products in the Office of New Drugs at the FDA's Center for Drug Evaluation and Research, discusses the intentions of the new REMS and its potential influence on patient care in a recent interview with Medscape. More information

FDA Launches precisionFDA to Harness the Power of Scientific Collaboration

Taha A. Kass-Hout, M.D., M.S., FDA’s Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics, and Elaine Johanson, precisionFDA Project Manager discuss precisionFDA - an online, cloud-based, portal that will allow scientists from industry, academia, government and other partners to come together to foster innovation and develop the science behind a method of “reading” DNA known as next-generation sequencing (or NGS). More information

FDA Voice Blog: What We Mean When We Talk About Data

The incorporation of evidence derived from data gathered from patient experiences represents an important step toward a fundamentally better understanding of states of disease and health. As we begin to adapt “real-world data” into our processes for creating scientific evidence, and address their challenges, we are likely to find that the quality of the answers we receive will depend in large part on whether we can frame the questions in a meaningful way. More information

Who's in Clinical Trials?

Have you ever wondered if someone like you participated in the clinical trials for a new drug? Through Drug Trials Snapshots, FDA is addressing concerns raised by advocacy groups and the public, including important issues such as tracking information about how many women and minorities participate in drug trials. FDA is making demographic information from clinical trials more easily available to consumers through its online Drug Trials Snapshots database. FDA hopes this initiative will further the discussion about how individuals might respond differently to the same drug. More information

OPPORTUNITIES FOR COMMENT / GUIDANCES

Draft Guidance for Industry on Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices

Draft guidance titled, "Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices" has recently been posted. When finalized, this draft guidance document will recommend non-clinical and clinical studies to support a premarket approval (PMA) for implantable minimally-invasive glaucoma surgical (MIGS) devices. More information

Draft Guidance on the Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

FDA is announcing the availability of a draft document entitled “Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry.” The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps with recommendations for testing living donors for West Nile Virus, and recommends the use of an FDA-licensed nucleic acid test (NAT) to test living donors of HCT/Ps for evidence of infection with WNV.More information

PRODUCT APPROVALS & CLEARANCES

FDA clears military traumatic wound dressing for use in the civilian population

FDA cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. XSTAT 30 is cleared for use in patients at high risk for immediate, life-threatening, and severe hemorrhagic shock and non-compressible junctional wounds, when definitive care at an emergency care facility cannot be achieved within minutes. More information

FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery

FDA approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults. More information

FDA approves new oral therapy to treat ALK-positive lung cancer

FDA approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib). More information

FDA approves first emergency treatment for overdose of certain types of chemotherapy

FDA approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments. More information

FDA allows marketing of cooling cap to reduce hair loss during chemotherapy

FDA cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy. More information

FDA approves first recombinant von Willebrand factor to treat bleeding episodes

FDA approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with VWD. More information

FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients

FDA approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency. More information

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

PRODUCT SAFETY

Need Safety Information?

For more important safety information on human drugs, medical devices, dietary supplements and more, or to report a problem with a medical product, please visit MedWatch. To receive MedWatch Safety Alerts by emailsubscribe here.

Recall: Chariot Guiding Sheath by Boston Scientific- Risk of Shaft Separation

Boston Scientific has voluntarily recalled the Chariot Guiding Sheath due to the risk of shaft separation. The most severe outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. All affected healthcare facilities are advised to immediately discontinue use of affected devices and return unused Chariot Guiding Sheaths to Boston Scientific. More information

Drug Safety Communication: Rosiglitazone-containing Diabetes Medicines - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)

FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. In 2013, FDA required removal of the prescribing and dispensing restrictions for rosiglitazone medicines after determining that data did not demonstrate an increased risk of heart attack with rosiglitazone medicines compared to the standard type 2 diabetes medicines metformin and sulfonylurea.The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks. More information

Drug Safety Communication: Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical - FDA Warns of Potential Contamination

Certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs. The affected API may potentially pose serious safety risks for patients who receive injectable drug products compounded with the affected baclofen, especially when administered directly into the spinal column. More information

Recall: Pink Bikini Dietary Supplement by Lucy's Weight Loss System - Undeclared Drug Ingredient

Lucy's Weight Loss System is voluntarily recalling all lots of Pink Bikini White powder Capsules, 30 white (750MG per capsule) to the consumer level. Pink Bikini has been found positive for diclofenac after FDA sampling and testing. Diclofenac is an NSAID and may increase the risk of fatal heart attack or stroke, especially if it is taken long term or in high doses. Taking diclofenac during the last three months of pregnancy may harm the unborn baby. Consumers should stop using and discard affected lots. More information

Class I Recall: Inspiration LS, 5i and 7i Ventilator Systems by eVent Medical - May Shut Down without Alarm

eVent Medical is recalling the LS, 5i, or 7i Inspiration ventilators because a faulty switch on the ventilators’ power board may fail, causing the ventilator to shut down without sounding an alarm. If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death. More information

Drug Safety Communication: SGLT2 Inhibitors - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections

An FDA safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of ketoacidosis and of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections. Both conditions can result in hospitalization. More information

Recall: Lipo Escultura - Undeclared Drug Ingredients

Lipo Escultura Corp. of Brooklyn, NY are voluntarily recalling all Lipo Escultura within expiry to the consumer level. The Lipo Escultura capsules were tested by the FDA and have been found to contain sibutramine and diclofenac. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. More information

Safety Notification: OmniPod Insulin Management System by Insulet - Reported Cases of Needle Mechanism Deployment Failure or Delay

Insulet Corporation initiated a lot-specific voluntary Field Safety Notification for the OmniPod due to a slight increase in the reported cases in which the Pod’s needle mechanism failed to deploy or there was a delay in the deployment of the needle mechanism. In the event a needle mechanism fails to deploy, the needle will not be inserted and insulin delivery will not begin. More information

November 2015 Drug Safety Labeling Changes

Pharmacists in the Office of Health and Constituent Affairs reviewed November 2015 labeling changes to inform you of 19 products with safety revisions to prescribing information. More information

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.

MDUFA Reauthorization Patient and Consumer Stakeholder Meeting (Dec 18)

FDA will host a meeting to discuss the reauthorization of the Medical Device User Fee Amendments (MDUFA). During this meeting, representatives from patient and consumer advocacy groups can discuss their views on reauthorization and provide suggestions for improving the program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next MDUFA program, and that FDA hold discussions with representatives of patient and consumer groups at least monthly during FDA's negotiations with the regulated industry. More information

BsUFA Public Meeting (Dec 18)

On December 18, 2015, FDA is holding a public meeting to discuss the reauthorization of BsUFA. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA hold public meetings and conduct discussions with both the regulated industry in developing recommendations for the next BsUFA program (FY2018-2022). More information

Psychopharmacologic Drugs Advisory Committee Meeting (Jan 12)

The committee will discuss new drug application (NDA) 204442, PROBUPHINE (buprenorphine hydrochloride and ethylene vinyl acetate) subdermal implant, submitted by Braeburn Pharmaceuticals, Inc., on behalf of Titan Pharmaceuticals for the proposed indication of maintenance treatment of opioid dependence. More information

Vaccines and Related Biological Products Advisory Committee Meeting (Jan 14)

The committee will hear updates of the research program in the Laboratory of Method Development, Division of Viral Products, Center for Biologics Evaluation and Research, FDA. The committee will meet by teleconference. More information

Public Workshop – Moving Forward: Collaborative Approaches to Medical Device Cybersecurity (Jan 21-22)

FDA, in collaboration with the National Health Information Sharing Analysis Center (NH-ISAC), the Department of Health and Human Services and the Department of Homeland Security, seek to bring together diverse stakeholders to discuss complex challenges in medical device cybersecurity that impact the medical device ecosystem. The purpose of this workshop is to highlight past collaborative efforts, increase awareness of existing maturity models which are used to evaluate cybersecurity status, standards, and tools in development, and to engage the multi-stakeholder community in focused discussions on unresolved gaps and challenges that have hampered progress in advancing medical device cybersecurity. More information

Public Workshop – Point of Care Prothrombin Time/International Normalized Ratio Devices for Monitoring Warfarin Therapy (Jan 25)

The purpose of this workshop is to discuss and receive input from stakeholders regarding approaches to the analytical and clinical validation of point of care (POC) Prothrombin Time/International Normalized Ratio (PT/INR) in vitro diagnostic devices for improved clinical management of warfarin therapy in addition to describing the FDA’s process for facilitating the development of safe and effective POC and patient self-testing PT/INR devices. More information

The Twentieth FDA CASSS Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (Jan 26)

Objectives of this meeting include discussing the latest bio-analytical methods and their practical application to biotechnological pharmaceuticals (BPs) and other health-related products, and soliciting feedback from industry, academia, government, and other stakeholders on advancements in bio-analytical methods and their application to BPs. More information

RESOURCES

For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch

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. Comunicaciones de la FDA

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.More information

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 More information

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. More information

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. More information

FDA Voice

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

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. More information