FDA Updates for Health Professionals

As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs 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. July 16, 2014 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. Problem With a Medical Product?  Tell FDA about problems with human drugs, medical devices and more using the MedWatch Online Voluntary Reporting Form   June 2014 Safety Labeling Changes Safety Labeling Changes includes 52 products with revisions to Prescribing Information. More information Sterile Drug Products by Unique Pharmaceuticals Ltd.: Alerting Health Care Professionals - Lack of Sterility Assurance FDA is alerting health care professionals, including hospital supply managers and hospital staff, not to use drugs marketed as sterile produced by Unique Pharmaceuticals Ltd., a company located in Temple, Texas, as they may be contaminated. More information Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination Hospira, Inc. announced it is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000 mL, Flexible Container. This action is due to one confirmed customer report where particulate was identified within the solution of the primary container. More information Weight Loss Products: Public Notification - Undeclared Drug Ingredients The FDA is advising consumers not to purchase or use Mix Fruit Slimming, Lingzhi Cleansed Slim Tea, 24 Ince, Lipo 8 Burn Slim Capsules, Sliming (sic) Diet By Pretty White, and Trim-Fast Slimming Softgel products promoted and sold for weight loss on various websites and possibly in some retail stores. FDA laboratory analysis confirmed that these products contains sibutramine. Laboratory analysis also confirmed that Mix Fruit Slimming contains phenolphthalein. More information Langston V2 Dual Lumen Catheters (Models 5540 and 5550) by Vascular Solutions: Class I Recall - Inner Catheter May Separate During Use and Cause Injury Vascular Solutions received reports that the inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during use. More information Medtronic Duet External Drainage and Monitoring System, Medtronic Neurosurgery: Class I Recall - Tubing May Disconnect and Lead to Injury FDA notified healthcare professionals of a Class I recall of Medtronic Duet External Drainage and Monitoring System. The firm recalled the device because the patient line tubing may separate from the patient line connectors. 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 Beleodaq to Treat Rare, Aggressive Form of non-Hodgkin Lymphoma FDA approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency's accelerated approval program. 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 Draft Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors The draft guidance announced in this notice is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The draft guidance provides the Agency's recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations. More information Reopening of the Comment Period: Use of Innovative Packaging, Storage, and/or Disposal Systems To Address the Misuse and Abuse of Opioid Analgesics FDA is reopening the comment period to allow interested persons additional time to submit comments. More information ANNOUNCEMENTS FDA Basics Webinar: "Over-The-Counter Medicines and Driving" FDA's Center for Drug Evaluation and Research (CDER) hosted a 30-minute webinar to communicate the risks that some common over-the-counter (OTC) medicines may cause drowsiness or impair driving. The featured speaker, Dr. Ali Mohamadi, a medical officer on CDER's Professional Affairs and Stakeholder Engagement staff, discussed OTC medicines that can cause drowsiness or impair driving. Also, he explained how to read the label on over-the-counter medicines to see if it is safe to drive. More information FDA Posts Strategic Plan for Accelerating the Development of Therapies for Pediatric Rare Diseases The strategies outlined in the plan will help FDA achieve a major goal of the Food and Drug Administration Safety and Innovation Act (FDASIA), which is to speed the development of therapies for children with rare diseases. More information Upcoming Webinar- Thursday August 7th: "As Seen on TV: Integrating Tobacco Education Campaigns into Your Clinical Practice" Hosted by the American Academy of Pediatrics and moderated by the American Academy of Family Physicians, this webinar will provide information about two hard-hitting tobacco education campaigns currently in the media- the Centers for Disease Control and Prevention's Tips From Former Smokers campaign and the Food and Drug Administration's The Real Cost campaign. The webinar will also feature a discussion about the clinician connection to these campaigns, and how the campaigns can be used to bolster discussions with patients and families about cessation issues. 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. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (July 30-31) The committee will discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the Ablatherm Integrated Imaging device sponsored by EDAP Technomed, Inc.  More information The Development of New Antibacterial Products: Charting a Course for the Future (July 30-31) The National Institutes of Health (NIH) and FDA will host a two-day workshop to explore key issues and challenges related to antibacterial product development and discuss the development of streamlined regulatory pathways for bringing new antibacterial drugs to market.  More information Blood Products Advisory Committee Meeting Announcement (July 31) The committee will meet in open session to discuss Baxter Healthcare Corporation's biologics license application for HyQvia, Immune Globulin Infusion 10 percent (human) combined with Recombinant Human Hyaluronidase for the treatment of patients with primary immune deficiency disorders. The committee will meet in open session to discuss reentry of blood donors deferred on the basis of Chagas disease test results.  More information   General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (August 1) The committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc.  More information Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement (August 15) The committee will discuss the new drug application (NDA) 21936, for tiotropium bromide inhalation spray, submitted by Boehringer Ingelheim Pharmaceuticals, Inc. for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and for reducing COPD exacerbations.  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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