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 30, 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 GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC): Class I Recall - CO2 Detector May Fail Leading to Injury The affected CO2 detectors may fail or provide incorrect CO2 values for mechanically and spontaneous ventilated patients. Physicians may make decisions based on incorrect values which could lead to permanent, irreversible impairment or life-threatening changes in patients. Patients may experience an inadequate exchange of gases (hypoventilation), causing an increased concentration of CO2 (hypercapnia). Death may also occur as a result of low CO2 values. More information Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error Diabetic Supply of Suncoast, Inc. initiated a nationwide voluntary recall of all BMB-BA006A Advocate Redi-Code+ blood glucose test strip lots manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the Redi-Code+ BMB-BA006A blood glucose test strips are designed to be used with.  More information Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging American Health Packaging (AHP) voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600 mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300 mg, lot #142544. In addition, AHP voluntarily recalled Oxcarbazepine Tablets, 300 mg, lot #142544, Expiration Date, 02/2016. This recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine.  More information Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance FDA is alerting health care professionals and consumers not to use drugs marketed as sterile produced by Downing Labs LLC, also known as NuVision Pharmacy, in Dallas, as they may be contaminated. More information Baxter IV Sodium Chloride and Potassium Chloride Solutions: Recall - Particulate Matter Baxter International Inc. initiated a voluntary recall of four lots of intravenous (IV) solutions to the hospital/user level. These products have been found to contain particulate matter identified as cellulosic fibers and/or plastics. More information Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates Hospira, Inc. is recalling one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free, to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide. 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 new product to treat rare genetic disease Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema was approved. More information FDA approves Zydelig for three types of blood cancers Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA. More information FDA approves new extended-release oxycodone with abuse-deterrent properties Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. More information FDA expands approved use of Imbruvica for chronic lymphocytic leukemia FDA expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. 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 Comment Request: Experimental Study of Direct-to-Consumer Promotion Directed at Adolescents Sponsors for several prescription drug classes market their products directly to vulnerable groups, including adolescents. Such DTC marketing to adolescents raises a variety of potential concerns. More information Exploring the Possibility of Proprietary Name Reservation for Drug Products; Establishment of a Public Docket FDA is establishing a public docket to discuss issues related to reserving proprietary names for drug products. During the negotiations for the 2007 reauthorization of the Prescription Drug User Fee Amendments Act (PDUFA IV), FDA agreed to several performance goals related to the review of drug and biological product proprietary names to reduce medication error. More information Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations FDA is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications. More information  ANNOUNCEMENTS FDA Commissioner Margaret A. Hamburg's Statement on the Surgeon General's Call to Action to Prevent Skin Cancer Each year, thousands of Americans are diagnosed with some form of skin cancer. The Surgeon General's Call to Action to prevent skin cancer is important especially during these hot summer months when many of us spend extra time in the sun. 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. 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 Nonprescription Drugs Advisory Committee Meeting (September 3-5) On September 3, the committee will discuss the standards used to demonstrate that over-the-counter (OTC) topical antiseptics used in healthcare settings are generally recognized as safe and effective. On September 4-5, the committee will discuss the scope of safety testing that should be required for sunscreen active ingredients to be marketed in U.S. over-the-counter (OTC) sunscreen products. More information Cardiovascular and Renal Drugs Advisory Committee Meeting (September 9-10) The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. Also, the committee will discuss new drug application (NDA) 206302, nebivolol/valsartan fixed-dose combination tablets, submitted by Forrest Laboratories, Inc., for the proposed indication of the treatment of hypertension. More information Endocrinologic and Metabolic Drugs Advisory Committee Meeting (September 12) The committee will discuss biologics license application (BLA) 125511, proposed trade name NATPARA (established name: Recombinant Human Parathyroid Hormone (rDNA) or (rhPTH[1-84]), submitted by NPS Pharmaceuticals, Inc., for the proposed indication of replacement for endogenous parathyroid hormone (1-84) for the long-term treatment of hypoparathyroidism. More information Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting (September 17-18) The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use. More information Cellular, Tissue and Gene Therapies Advisory Committee Meeting (September 18) The committee will hear updates of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, the Laboratory of Molecular Oncology and the Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, Office of Biotechnology Products, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, FDA. More information Pediatric Advisory Committee Meeting (September 23) The Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by The Food and Drug Administration Safety and Innovation Act. 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

---

Subscriber Services:
Manage Preferences  |  Unsubscribe  |  Help with this service

Stay Connected:

---

This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420