As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs (formerly the Office of Special Health Issues) wants to make you aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the topics with a brief summary and links to detailed information on the FDA Web site.
April 9, 2014
FDA Health Professional Organizations Annual Conference
The aim of the conference is to further the public health mission of the FDA through training, collaboration, and structured discussion between health professional organizations and FDA staff. The Office of Health and Constituent Affairs (OHCA) serves as a liaison between the FDA Centers and the public on matters that involve medical product safety. Click here to register!
PRODUCT SAFETY
Need Safety Information?
For more important safety information on human drugs, medical devices, dietary supplements and more, please visit MedWatch. To receive MedWatch Safety Alerts by email subscribe here.
Zi Xiu Tang Bee Pollen Capsules by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd: Warning - Undeclared Drug Ingredients
Risk of increased blood pressure and/or pulse rate. More information
PS500 Power Supply Unit by Dräger: Recall - Early Depletion of Battery Charge
Battery depletion will require manual ventilation until the device is connected to main power. More information
HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction - Updated Labeling and Training Materials
UPDATED 04/01/2014. Class I Recall. 4 deaths and 5 incidents of loss of consciousness or symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being trained on an older model. More information
Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension
Health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient. More information
Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients
Sildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. More information
Some packages of the product were tampered with and may contain product that is not authentic. More information
Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients
Sildenafil and tadalafil can interact with nitrates found in some prescription drugs (such as nitroglycerin), resulting in decreased blood pressure. More information
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 en druginfo@fda.hhs.gov. Comunicaciones de la FDA
For more important safety information on human drug and devices or to report a problem to FDA, please visit MedWatch
PRODUCT APPROVALS & CLEARANCES
FDA approves Topamax for migraine prevention in adolescents
FDA approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. . More information
FDA approves first long-acting recombinant coagulation Factor IX concentrate for patients with Hemophilia B
FDA approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. More information
FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
FDA approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem. More information
FDA approves first sublingual allergen extract for the treatment of certain grass pollen allergies
FDA approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care provider's office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home. More information
FDA approves new hand-held auto-injector to reverse opioid overdose
FDA approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness. More information here and here
FDA allows marketing for first-of-kind dressing to control bleeding from certain battlefield wounds
FDA allowed marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XSTAT is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as the groin or armpit. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care. More information
For more information on drug approvals or to view prescribing information and patient information, please visit Drugs at FDA or DailyMed
OPPORTUNITIES FOR COMMENT / GUIDANCES
FDASIA Health IT Report
HHS released a draft report that includes a proposed strategy and recommendations for a health information technology (health IT) framework, which promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally mandated report was developed in consultation with health IT experts and consumer representatives and proposes to clarify oversight of health IT products based on a product's function and the potential risk to patients who use it.
There are some areas of health IT oversight that will benefit from continued engagement, including clinical decision support IT and electronic health records. For that reason, the FDA is opening a docket (FDA-2014-N-0339) to accept comments on the report. In the coming weeks the FDA will announce dates for a 3-day public meeting to discuss the report. More information
Public Hearing on FDASIA Section 907
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data (i.e. sex, race/ethnicity, and age) in applications for approval of FDA‐regulated medical products. The Agency will utilize input from this public hearing to develop a plan that is pragmatic and public‐health focused. There will be an opportunity for attendees to make oral presentations during the meeting. The deadline for registering as a presenter is March 21, 2014. There is also an open public docket for the meeting. Comments will be accepted until May 16, 2014. More information
Over-The-Counter Drug Monograph System — Past, Present and Future
FDA is interested in obtaining patient input on the impact of fibromyalgia on daily life and patients' views on currently available therapies to treat the condition. In addition to providing input at the public meeting, patient stakeholders can provide their perspectives on the discussion questions through the public docket. The docket closes on May 26, 2014. To submit your comments, visit http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-1041-0004. More information
ANNOUNCEMENTS
Consumer Update: Fighting Diabetes' Deadly Impact on Minorities
The Office of Minority Health (OMH) at the Food and Drug Administration (FDA) is building relationships with the American Diabetes Association (ADA) and other groups to help Americans prevent and treat diabetes, and to address the disparity in how severely it affects minority groups in particular. More information
DRUG SHORTAGES AND DISCONTINUATIONS
FDA takes great efforts, within its legal authority, to address and prevent drug shortages, which can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations.Shortage notifications and updates may be reported to FDA at drugshortages@fda.hhs.gov
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.
On April 16, 2014, the committee will consider scientific issues pertaining to dependence and addiction. On April 17, 2014, the committee will receive information on population modeling in the assessment of tobacco product applications and discuss the ways modeling can inform decisions critical to population health. More information
Pediatric Advisory Committee Meeting (Apr 21)
The committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107–109) and the Pediatric Research Equity Act (Pub. L. 108–155). More information
Anesthetic and Analgesic Drug Products Advisory Committee Meeting (Apr 22)
The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids. More information
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Request for Comments (Apr 24)
On April 24, 2014, the committee will discuss the current knowledge about the safety and effectiveness of aversive conditioning devices that are intended to deliver a noxious electrical stimulus to a patient to modify undesirable behavioral characteristics. FDA is convening this committee to seek clinical and scientific expert opinion on the risks and benefits of certain aversive conditioning devices based on available scientific data and information. More information
Risk Communication Advisory Committee Meeting (May 5-6)
On May 5-6, 2014, the Committee will meet to discuss methods for identifying the impact and increasing the reach of communications on topics of interest to consumers. The discussion will also address how FDA can evaluate whether its Consumer Updates are reaching the targeted population, and whether they are increasing awareness and understanding of the key risk messages. More information
Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice Conference (May 15-16)
FDA is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The conference on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. More information
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (May 21-22)
On May 21, the committee will discuss the classification of one of the remaining preamendments class III devices, shortwave diathermy for all other uses except for the treatment of malignancies. On May 22, the committee the committee will discuss and make recommendations regarding the 515(i) order issued by FDA on April 9, 2009 (Docket No. FDA-2009-M-0101). More information
RESOURCES
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
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
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