FDA Updates for Health Professionals

January 30, 2013

PRODUCT SAFETY Class 1 Recall: Vycor Viewsite Brain Access System (VBAS) - Unidentified Fiber Found on Device Vycor Medical recalled its VBAS because an unidentified black fiber was found on the device. This product may cause serious adverse health consequences, including death. More information Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000 ML, Flexible Containers: Recall - Due to Non-Sterility One confirmed customer report where a spore-like structured particulate, consistent with mold, was noted in the solution. More information Recall: Super Power - Undeclared Ingredient Finished product of Super Power was tested and found to contain trace amounts of sildenafil. More information Drug Warning: Samsca (tolvaptan) - Potential Risk of Liver Injury Large clinical trial findings of significant elevations of both ALT and bilirubin. More information Class I Recall: Bausch and Lomb 27G Sterile Cannula Packed in Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices (OVD) - Cannulas May Leak or Detach From the Syringe Bausch and Lomb notified heathcare professionals of a Class I recall of certain Bausch and Lomb 27G Sterile Cannula Packed in Bausch and Lomb Amvisc 1.2 percent Sodium Hyaluronate (Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6 percent Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) Ophthalmic Viscosurgical Device. More information Recall: Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement - Bottle May Contain Meclizine HCl 25 mg Tablets Advance Pharmaceutical Inc. notified the public of a recall of one lot of Ferrous Sulfate Tablets 325 mg, after notification by a pharmacist that a bottle of Ferrous Sulfate Tablets, 325 mg contained Meclizine HCl 25 mg tablets. The lot of the Rugby Ferrous Sulfate is 12G468. More information FDA Safety Communication: Metal-on-Metal Hip Implants - Updated Safety Recommendations FDA notified healthcare professionals that it is providing updated safety information and recommendations to patients and health care providers, based on the FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting. 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 FDA approves new orphan drug Kynamro to treat inherited cholesterol disorder FDA approved Kynamro (mipomersen sodium) injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). More information FDA approves three new drug treatments for type 2 diabetes FDA approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets. More information FDA approves Gleevec for children with acute lymphoblastic leukemia FDA approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). More information FDA approves over-the-counter Oxytrol for Women to treat overactive bladder FDA approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women ages 18 years and older. Oxytrol will remain available for men with overactive bladder by prescription only. More information FDA approves Exjade to remove excess iron in patients with genetic blood disorder FDA expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT). The FDA is also authorizing marketing of FerriScan as an imaging companion diagnostic for Exjade therapy in patients with NTDT. More information FDA approves Botox to treat overactive bladder FDA expanded the approved use of Botox (onabotulinumtoxinA) to treat adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics. More information FDA approves new seasonal influenza vaccine made using novel technology FDA approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology. Flublok is approved for the prevention of seasonal influenza in people 18 through 49 years of age. 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: Smokeless Tobacco Product Warning Statements 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. Submit electronic or written comments by April 1, 2013. More information Guidance for Industry and Food and Drug Administration Staff - Humanitarian Use Device (HUD) Designations Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. This guidance finalizes the draft guidance of the same title dated December 2011. More information Comment Request: Food Labeling - Notification Procedures for Statements on Dietary Supplements FDA invites comments on the information collection provisions of the regulation requiring manufacturers, packers, and distributors of dietary supplements to notify us that they are marketing a dietary supplement product that bears on its label or in its labeling a statement provided for in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Submit either electronic or written comments on the collection of information by March 19, 2013. More information Antiseptic Patient Preoperative Skin Preparation Products; Public Hearing; Request for Comments FDA will be holding a public hearing to obtain input on how to address microbial contamination of patient preoperative skin preparation drug products.Comments will be accepted until February 12, 2013. More information ANNOUNCEMENTS Flu and the FDA: An Interview With Margaret A. Hamburg, MD Medscape spoke with Margaret A. Hamburg, MD, Commissioner of the US Food and Drug Administration (FDA), about the FDA's efforts to address shortages and other issues related to pharmacologic management of influenza. More information Grant Funds: 2013 Assuring Radiation Protection FDA is announcing the availability of grant funds for the support of the Center for Devices and Radiological Health (CDRH) radiation protection program. More information Consumer Update: Don’t Double Up on Acetaminophen More than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever. Taken carefully and correctly, these medicines can be safe and effective. But taking too much acetaminophen can lead to severe liver damage. More information Consumer Update: At FDA, Pharmacists Answer Your Call From their offices in Silver Spring, Md., FDA pharmacists answer thousands of calls to 1-888-INFO-FDA each year. More information The Evolution, and Revolution, of Flu Vaccines The manufacturing of flu vaccines is a highly-orchestrated and complex process. FDA and its parent, the U.S. Department of Health and Human Services, have long encouraged the development of new technologies for producing flu vaccines. 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. Public Hearing - Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need (Feb 4-5) FDA is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. More information Public Hearing - Impact of Approved Drug Labeling on Chronic Opioid Therapy (Feb 7-8) To obtain information, particularly scientific evidence, such as study data or peer-reviewed analyses, on issues pertaining to the use of opioid drugs in the treatment of chronic pain. More information Risk Communication Advisory Committee Meeting (Feb 12) The Committee will discuss general factors in risk communication about FDA regulated products, including approaches to avoid message fatigue and related communication barriers such as prevention or warning fatigue or inaccurate risk perception. More information Medical Imaging Drugs Advisory Committee Meeting (Feb 14) The committee will discuss new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), application submitted by Guerbet, LLC. More information Neurological Devices Panel of the Medical Devices Advisory Committee Meeting (Feb 22) The committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace RNS System sponsored by NeuroPace, Inc.  The RNS System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci that are refractory to two or more antiepileptic medications. More information Public Workshop - Clinical Flow Cytometry in Hematologic Malignancies (Feb 25-26) FDA is seeking input from academia, Government, laboratorians, industry, clinicians, patients and other stakeholders on the role of clinical flow cytometry in hematologic malignancies, in order to develop a specific regulatory policy for this class of in vitro diagnostic devices. More information Public Workshop - Minimal Residual Disease (Feb 27) FDA in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL). More information Meeting - Science Board to the Food and Drug Administration (Feb 27) The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex scientific and technical issues important to the FDA and its mission, including emerging issues within the scientific community. More information Vaccines and Related Biological Products Advisory Committee Meeting (Feb 27) The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccine for the 2013-2014 influenza season More information Public Workshop - Minimal Residual Disease (Mar 4) FDA in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia (AML). More information Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee Meeting (Mar 5) The committees will discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) outweighs a potential risk of cancer. More information Pulmonary-Allergy Drugs Advisory Committee Meeting (Mar 7) The committee will discuss the new drug application (NDA) 204275 for fluticasone furoate and vilanterol dry powder inhaler (proposed tradename 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 Public Conference - Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It? (Mar 20-21) The conference purpose is to discuss, debate, and build consensus among stakeholders in the pharmaceutical industry, academia, health care providers, patient groups, and regulatory bodies on how best to detect and assess the severity, extent, and likelihood of drug causation of liver injury and dysfunction in people using drugs for any medical purpose. More information Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting The committee will discuss and make recommendations regarding the possible reclassification of Shortwave Diathermy 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