FDA Updates for Health Professionals ► March 27, 2013

March 27, 2013

PRODUCT SAFETY Recall: Palimed Solutions, Inc. Sterile Compound Products - Visible Particulates Observed Pallimed Solutions is voluntarily recalling all sterile compound products dispensed since January 1, 2013 to the user level, including all strengths, all dose forms, and all products within expiry date. Recent inspections conducted by the FDA and the Massachusetts Board of Registration in Pharmacy found visible particulates (filaments) observed in vials of several different sterile compounded products. See the Press Release for a listing of all products affected by this recall. More information  Class I Recall: Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves - Risk of Air Being Introduced Into Device The firm is recalling the product due to a risk that air may be introduced into the device which may lead to an air embolism. This product may cause serious adverse health consequences, including death. More information Class I Recall:Spacelabs Anesthesia Workstations and Service Kits - Defect in CAS I/II Absorbers There is a defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits that may cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. This product may cause serious adverse health consequences, including death. More information Recall: Clinical Specialties Compounding Pharmacy  - All Sterile Products Recalled Due To Lack of Sterility Assurance Clinical Specialties is voluntarily recalling all lots of all sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products. More information Recall: Avastin Unit Dose Syringes by Clinical Specialties - Potential For Serious Eye Infection Clinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified. More information Class I Recall: Symbios Medical Products, LLC, GOPump Elastomeric Infusion PumpKit, Part Number 510076 The flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended. This product may cause serious adverse health consequences, including death. More information Recall: Med Prep Consulting Inc. Compounded Products - Potential Mold Contamination Med Prep Consulting, Inc.  is recalling all lots of all products compounded at its facility, due to lack of sterility assurance. The level of recall is to the user: regional hospital pharmacies and related departments, and physician’s office practices. More information    Updated FDA Safety Communication: Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Reports of Serious Tissue Damage and Patient Death FDA is aware of health care facilities' concerns about implementing Stryker's Neptune Pre-use Checklist and training program to comply with Stryker's updated Certificate of Medical Necessity (CMN) program.  Stryker has a website to address customer concerns that provides training materials, including webinars and a training assessment, for facilities using the Neptune 1 Silver and Neptune 2 Ultra devices under the CMN. More information FDA Drug Safety Communication: FDA investigating reports of possible increased risk of pancreatitis and pre-cancerous findings of the pancreas from incretin mimetic drugs for type 2 diabetes FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics.  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 AND CLEARANCES FDA approves new multiple sclerosis treatment: Tecfidera FDA approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS). MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body.   More information  FDA approves first Botulism Antitoxin for use in neutralizing all seven known botulinum nerve toxin serotypes FDA has approved Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) to treat patients showing signs of botulism following documented or suspected exposure to botulinum neurotoxin. The product is derived from horse plasma and contains a mixture of antibody fragments that neutralize all of the seven botulinum nerve toxin serotypes known to cause botulism.  More information FDA approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosis patients FDA  approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections. More information FDA approves Dotarem, a new magnetic resonance imaging agent FDA  approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older. Dotarem is a gadolinium-based contrast agent (GBCA) that helps radiologists see abnormalities on images of the central nervous system (CNS), the part of the body that contains the brain and spine, and surrounding tissues.  More information  FDA approves the ArterX Surgical Sealant - P100030 The Tenaxis Medical ArterX Surgical Sealant (ArterX) is a medical sealant that is used to help stop leaks in blood vessels. It is made of two components, bovine serum albumin (BSA) and polyaldehyde. The BSA component is derived from cow (bovine) tissue. The two components are contained in separate barrels of a syringe. 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 Smokeless Tobacco Product Warning Statement FDA is establishing a public docket to obtain comments, supported by scientific evidence, regarding what changes to the smokeless tobacco product warnings, if any, would promote greater public understanding of the risks associated with the use of smokeless tobacco products. Comments are due by April 1, 2013. More information Request for Comments: Impact of Approved Drug Labeling on Chronic Opioid Therapy FDA invites comments on the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive. Over the past several years, the role of opioid drugs in treating chronic pain has been an increasingly common subject of public discussion. FDA and other policymakers have been at the forefront of these debates, striving to find a balance between minimizing opioid drug abuse and misuse, while simultaneously enabling appropriate access to pain-relieving drugs. Comments are due by April 8, 2013. More information Request for Comments: Draft Guidance for Industry on Alzheimer's Disease - Developing Drugs for the Early Stage Disease This guidance outlines FDA's current thinking as to how a sponsor could demonstrate efficacy in clinical trials in patients in the early stages of Alzheimer's disease (AD) that occur before the onset of overt dementia. Specifically, this guidance addresses FDA's current thinking regarding the selection of patients with early AD, or who are determined to be at risk of developing AD, for enrollment into clinical trials. Comments are due by April 9, 2012.  More information Request for Comments: Draft Guidance for Industry and FDA Staff - Providing Information About Pediatric Uses of Medical Devices This proposed rule would require each applicant who submits an humanitarian device exemption, premarket approval (PMA), supplement to a PMA, or product development protocol to include, if “readily available,” a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients. FDA is proposing to codify a definition of “readily-available” and also issue a draft guidance document to explain the Agency's current thinking on the meaning of “readily-available information” and how to comply with the requirements set forth in section 515A of the FD&C Act. Comments are due by April 22, 2013.  More information  Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan; Request for Comments FDA is announcing the availability of a draft 5-year plan describing the Agency's approach to further developing and implementing a structured framework for benefit-risk assessment in the human drug and biologic review process and the opportunity for public comment on the draft plan. This plan is part of FDA's commitments that were made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Comments are due by May 7, 2013. More information Requirements; Availability Request for Comments: FDA proposes new food safety standards for foodborne illness prevention and produce safety FDA proposed two new food safety rules that will help prevent foodborne illness. The proposed rules implement the landmark, bipartisan FDA Food Safety Modernization Act (FSMA) and are available for public comment for the next 120 days. The FDA encourages Americans to review and comment on these important proposed rules.  Comments are due by May 16, 2013. More information  Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act This notice solicits comments on submission of rotational plans for health warning label statements for smokeless tobacco products. Comments are due by May 17, 2013. More information Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding Regulations FDA is inviting comments from the public on whether any potential changes to the Federal drug regulations are necessary for medical gases. Comments are due by May 21, 2013 More information  Draft Guidance for Industry and Food and Drug Administration Staff - 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  Effective Date of Requirement for Premarket Approval for Automated External Defibrillator SystemRequest for Comment: FDA is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments devices: Automated external defibrillators systems (AEDs), which includes the AED device and its accessories (i.e., pad electrodes, batteries, and adapters). Comments are due by June 24, 2013.  More information  Center for Drug Evaluation and Research Medical Policy Council; Request for Comments FDA is announcing the establishment of a docket to receive suggestions, recommendations, and comments for topics from interested parties, including academic institutions, regulated industry, patient representatives, and other interested organizations, on medical policy issues that may be considered by the CDER Medical Policy Council (Council) in FDA's Center for Drug Evaluation and Research (CDER). These comments will help the Agency identify and address medical policy issues that need clarification through guidance, notice and comment procedures, or other means. Comments are due by July 16, 2013. More information  ANNOUNCEMENTS The FDA Office of Special Health Issues Has a New Name! The former Office of Special Health Issues, the FDA’s flagship contact for patients and healthcare professionals, will now be called the Office of Health and Constituent Affairs (OHCA). The Office will continue its core function of serving the needs of patients and healthcare professionals and managing the MedWatch program, but the new name showcases the emphasis placed on building a more robust and centralized office for all stakeholder engagement. More information  Letter to Stakeholders: Update on certain needleless pre-filled glass syringes FDA is providing an update on the issue of syringe connection problems when certain pre-filled glass syringes are used with some needleless luer access devices. FDA has approved a new generic product, diphenhydramine injection, which is contained in pre-filled glass syringes with modifications to address some of the connectivity concerns with luer access devices. More information FDA Webinar: Draft Guidance For Industry On Alzheimer’s Disease: Developing Drugs For The Treatment Of Early Stage Disease; Availability - March 28, 2013 On March 28, 2013, at 1:00 p.m. EDT, FDA will present a webinar on a new draft guidance entitled "Draft Guidance For Industry On Alzheimer’s Disease: Developing Drugs For The Treatment Of Early Stage Disease; Availability."   More information FDA Webinar: Enrichment Strategies For Clinical Trials To Support Approval Of Human Drugs And Biological Products FDA presented a webinar on a new draft guidance entitled "Webinar Draft GFI (Guidance for Industry) On Enrichment Strategies For Clinical Trials To Support Approval Of Human Drugs And Biological Products."    More information  National Hospice and Palliative Care Organization Webinar: Proper Medication Disposal: Current Strategies April 11, 2013, 2:00 pm - 3:30 pm ET This Webinar will examine the latest FDA policies and will identify other regulatory and enforcement agencies related to drug disposal. In addition, faculty will discuss current drug disposal strategies and practices, key compliance challenges and issues facing providers as well as the new DEA proposed rule on drug disposal and how it will impact hospice. 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  Updated Urogynecologic Surgical Mesh Implants Website In this website, the FDA describes pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the different surgical and non-surgical treatment options, recommendations for health care providers that treat women with POP and/or SUI, recommendations for patients who are considering surgery for these conditions and steps to report problems to the FDA. More information  Consumer Update:Temporary Tattoos May Put You at Risk Are temporary tattoos just a little harmless fun? Not necessarily, say FDA experts. Learn the potential dangers of temporary tattoos made with henna ink and how they have sent many people to the emergency room. More information Consumer Update: Putting a Patch on Migraines Migraines affect more than 30 million Americans. Learn about what causes migraines, the newest, FDA-approved form of migraine treatment—a patch—as well as other treatments and things you can do to prevent these painful headaches. 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. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Apr 5) The committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy devices. More information Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (Apr 8) The committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Trulign Toric posterior chamber intraocular lens sponsored by Bausch and Lomb. The Trulign Toric posterior chamber intraocular lens is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision and reduction of residual refractive cylinder. More information Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations; Public Workshop  (Apr 10) The purpose of this public workshop is to discuss research and development of multiplex assays and the use of these tests in blood donor screening and blood cell antigen typing. The public workshop will include presentations and panel discussions by experts from academic institutions, blood establishments, industry, and government agencies. More information Device Good Manufacturing Practice Advisory Committee Meeting (Apr 11) The committee will discuss the potential effects of extreme weather and natural disasters on medical device manufacturing chain processes and marketed medical device safety and quality. More information  Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting (Apr 17) The committee will discuss the new drug application (NDA) 204275, for fluticasone furoate and vilanterol dry powder inhaler (proposed trade name BREO ELLIPTA), sponsored by GlaxoSmithKline, for the long-term maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease. More information Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting (Apr 17) On April 17, 2013, the committee will meet by teleconference. In open session, the committee will hear updates of research programs in the Laboratory of Chemistry, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA. More information Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting (Apr 18) The committee will discuss the efficacy and safety of  AVEED (testosterone undecanoate) intramuscular injection, for the proposed indication of replacement therapy in adult males for conditions associated with a deficiency or absence of testosterone. The safety discussion will focus on postmarketing reports of oil embolism in the lungs and potential anaphylactic reactions. More information Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop (Apr 25-26) A public workshop to discuss how best to facilitate and expedite the development of safe and effective drug therapies to treat signs and symptoms related to chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME). FDA has determined that CFS and ME are serious conditions for which there are no approved drug treatments. More information Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (Apr 25-26) The committee will discuss and make recommendations on the appropriate regulatory classification for diagnostic devices known as methotrexate enzyme immunoassays,  phencyclidine (PCP) enzyme immunoassays, PCP radioimmunoassays, and isoniazid test strips. More information Risk Communications Advisory Committee; Notice of Meeting (Apr 29-30) The Committee will discuss general factors in risk communication about FDA-regulated products, including how to communicate effectively about FDA's adverse event reporting systems, and messaging in the context of competing communicators. More information Public Workshop - Accessible Medical Device Labeling in a Standard Content and Format (Apr 29-30) The purpose of the workshop is to discuss the growing need for medical device labeling to be delivered in a clear, concise, and readily accessible format so that patients, caregivers, and healthcare providers may access and utilize device labeling as efficiently and effectively as possible. More information Oncologic Drugs Advisory Committee Meeting (May 2) The committee will discuss NDA 204408, with the established name tivozanib capsules, indicated for the treatment of advanced renal cell carcinoma, and NDA 201848, a drug/device combination product with the proposed trade name Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System), indicated for the treatment of patients with unresectable ocular melanoma that is metastatic to the liver. More information General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (May 2) The committee will discuss, make recommendations and vote on information related to the premarket approval application for the Juvéderm Voluma XC sponsored by Allergan, Inc. Juvéderm Voluma XC is a dermal filler comprised of hyaluronic acid with lidocaine. Juvéderm Voluma XC is indicated for deep (dermal/subcutaneous and/or submuscular/supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement. More information Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (May 3) The committees will discuss the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. More information Summit on Color in Medical Imaging; Cosponsored Public Workshop (May 8-9) FDA and cosponsor International Color Consortium (ICC) are announcing the following public workshop entitled “Summit on Color in Medical Imaging: An International Workshop on the Technical Framework for Consistency and Interoperability Approaches for Dealing with Color in Medical Images.” The purpose of the workshop is to bring together key stakeholders to clearly identify areas of need, investigate solutions, and propose best-practice approaches. 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 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