FDA Updates for Health Professionals

June 5, 2013

PRODUCT SAFETY Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") notified the public of a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance. More information Nephron Pharmaceuticals Corp. EZ Breathe Atomizer: Class 1 Recall - Washer Could Become Dislodged A Medical Device Recall was issued due to a manufacturing defect which could result in the washer becoming dislodged from the EZ Breathe Atomizer. If this occurs, users may accidentally swallow the washer or choke on it, which can lead to serious adverse health consequences or death. More information Magnesium Sulfate: Drug Safety Communication - Recommendation Against Prolonged Use in Pre-term Labor FDA is advising health care professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women. Administration of magnesium sulfate injection to pregnant women longer than 5-7 days may lead to low calcium levels and bone problems in the developing baby or fetus, including thin bones, and fractures. More information Magnesium Sulfate Injection by Fresenius Kabi USA: Recall - Glass Particles in Vials Fresenius Kabi USA notified health professionals of a voluntary recall of one lot – Lot 6103882 – of Magnesium Sulfate Injection, USP due to the potential presence of glass particles in the vials. More information Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections Main Street Family Pharmacy, LLC has announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. More information Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall - Complaints of Delivery System Tip Separation Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. More information Fentanyl Transdermal System “Patches”: Safe Disposal The FDA Safe Use Initiative is launching an effort to increase public awareness about the safe use, storage and disposal of fentanyl transdermal system “patches” (Duragesic® and its generics). Healthcare providers can participate in this effort by talking to patients and their caregivers about proper disposal when they prescribe or dispense fentanyl patches. FDA has electronic and web-based educational resources that can be downloaded and printed from the website. The “Fentanyl Transdermal System (marketed as Duragesic) Information,” and the “Disposal of Unused Medicines: What You Should Know” webpages contain additional safety information. Healthcare providers can also join the FDA Safe Use Initiative in a broad-based collaborative effort to encourage safer use of fentanyl patches. 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 Clears First Blood Tracking Device that Uses Radio Frequency Identification Technology iTrace for Blood Centers, (Version 1.0.924.0), the first application to use Radio Frequency Identification technology in blood establishments to assist in enhancing blood safety by preventing the release of unsuitable blood components, was cleared today by FDA. More information FDA Approves Two Drugs, Companion Diagnostic Test for Advanced Skin Cancer FDA approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced or unresectable melanoma, the most dangerous type of skin cancer. More information FDA Allows Marketing of First A1c Test Labeled for Diagnosing Diabetes FDA announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by health care professionals. This is the first HbA1c test that FDA has allowed to be marketed 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 Request for Comments: Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers This guidance is intended to provide information for industry, researchers, physicians, and patients about certain aspects of FDA's implementation of its regulations on expanded access to investigational drugs for treatment use. FDA has received a number of questions about implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions. Comments are due by July 8, 2013. More information New Approaches to Antibacterial Drug Development; Request for Comments FDA is seeking input from the public on the following topics related to antibacterial drug development: Potential new study designs, proposed priorities for CDER guidances, and strategies intended to slow the rate of emerging resistance to antibacterial drugs. Submit electronic or written comments by July 30, 2013. More information Request for Comment: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products FDA is proposing to reclassify ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and to rename them sunlamp products. Submit either electronic or written comments on this proposed order by August 7, 2013. More information Request for Comments: Infant Formula - The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements FDA is proposing to amend the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula. Comments are due by July 1, 2013. More information Draft Guidance - Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability FDA is announcing the availability of a draft guidance for industry entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.”Submit either electronic or written comments on the draft guidance by June 24, 2013. More information Draft Guidance - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product or product container.  FDA is concerned that statements submitted for inclusion in medical product labeling, such as “latex-free,” “does not contain natural rubber latex,” or “does not contain latex” are not accurate because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. Comments are due by June 10, 2013.  More information  ANNOUNCEMENTS FDA Announces Import of Injectable Nutrition Drugs FDA announced that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week. More information MedWatch: Improving on 20 Years of Excellence This week FDA is proudly commemorating the 20th anniversary of MedWatch, a program which collects and reviews reports from health professionals and consumers about possible problems with drugs, medical devices and other products regulated by FDA. More information FDA Launches MedWatchLearn FDA is launching MedWatchLearn, a web-based learning tool designed to educate students, health professionals and consumers on reporting in a way that provides the best information for reviewers to further investigate a problem. More information Consumer Update: WANTED: Consumers to Report Problems A new consumer-friendly form is now available for making reports to MedWatch, FDA's on-line system for collecting information about serious problems with drugs, medical devices and other FDA-regulated products. More information Consumer Update: Keeping Drug Advertising Honest and Balanced Drug companies spend $25 billion a year in the U.S. promoting prescription medications, including a growing amount spent on direct-to-consumer advertising. Thomas Abrams, director of FDA's Office of Prescription Drug Promotions, discusses what his staff does to monitor for truth and balance. More information Consumer Update: Users of Last CFC Inhalers Must Soon Switch The last two inhalers in the United States that contain ozone-damaging chloroflurocarbons (CFCs) will both be taken off the market by the end of this year. People with asthma and chronic obstructive pulmonary disease who use these inhalers should talk to their health care providers about a prescription for an alternative. More information Consumer Update: Allergy Meds Could Affect Your Driving FDA wants to promote awareness of the potential health risks and the precautions that you should take when using antihistamines. More information UPCOMING MEETINGS FDA advisory committe 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. Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices (Jun 11-12) FDA is announcing its fifth public workshop on Computer Methods for Medical Devices entitled “FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.” More information Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 13) The committee will discuss and make recommendations regarding the possible reclassification of influenza detection devices, currently regulated as class I. More information Public Meeting: HIV Patient-Focused Drug Development and HIV Cure Research (Jun 14) FDA is announcing a public meeting and an opportunity for public comment on human immunodeficiency virus (HIV) Patient-Focused Drug Development and HIV Cure Research. More information Center for Devices and Radiological Health: Health of Women Program; Public Workshop; Request for Comments (Jun 24) FDA is announcing the following public workshop: “The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and Explore—HoW to Improve the Health of Women.” CDRH is developing the HoW Program to explore unique issues in the regulation of medical devices related to the health of women and seeks public input on the priority activities. The deadline for submitting comments related to this public workshop topic is July 31, 2013. More information Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 27) The committee will discuss and make recommendations regarding the proposed classification of sorbent hemoperfusion systems, one of the remaining preamendments class III devices. More information Meeting of the Drug Safety and Risk Management Advisory Committee (Jul 10) The Agency plans to discuss the risk management of Lotronex (alosetron hydrochloride) tablets which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome. The Agency will seek the committee’s comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system. More information Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (Jul 17) The committee will discuss the safety and efficacy for the new drug application, proposed trade name MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, for the indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. More information Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (Jul 18) The committee will discuss new drug application, sugammadex sodium injection, for the proposed indications of routine reversal of moderate and deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium and immediate reversal of NMB at three minutes after administration of rocuronium. More information Dental Products Panel of the Medical Devices Advisory Committee Meeting (Jul 18) The committee will discuss and make recommendations on the proposed regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the remaining preamendments Class III devices. More information Arthritis Advisory Committee Meeting (Jul 22) The committee will discuss the Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis and the implications of using these criteria for drug approval. More information Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Jul 24-25) On July 24, 2013, the committee will discuss Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. On July 25, 2013, the committee will discuss Kineflex Lumbar Artificial Disc sponsored by SpinalMotion. The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device. Public Meeting: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (Jul 25-26) FDA is announcing a 2-day public meeting to obtain input on issues and challenges associated with the standardization and assessment of risk evaluation and mitigation strategies (REMS) for drug and biological products. More information Public Workshop: Clinical Development Programs for Opioid Conversion (Jul 29) FDA is announcing a public scientific workshop to address public health concerns associated with the inclusion of equianalgesic opioid conversion tables in opioid product labels. Discussion will focus on the available data supporting the use of equianalgesic opioid conversion tables, problems associated with their use, and strategies used in clinical practice to convert patients from one opioid analgesic product to another. More information Battery-Powered Medical Devices Workshop (Jul 30-31) This meeting is a way to better understand and address the potential challenges related to the design/development, selection, purchase, use, and maintenance of battery-powered medical devices. It’s also designed to initiate greater collaboration among stakeholders to develop best practices, training, and industry standards for battery-powered medical devices. More information RESOURCES 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 Prouct 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