FDA Updates for Health Professional

July 3, 2013

PRODUCT SAFETY FDA Drug Safety Communication: Olmesartan Medoxomil- Label Changes To Include Intestinal Problems (Sprue-Like Enteropathy) FDA is warning that the blood pressure drug Olmesartan Medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. FDA has approved changes to the labels of these drugs to include this concern. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan. More information  Recall: RECOMBIVAX HB (Hepatitis B Vaccine (Recombinant)) Adult Formulation by Merck Sharp and Dohme Corp. - Potential For Cracked Vials Merck initiated this voluntary recall due to the potential for a limited number of cracked vials to be present in the lot. Merck’s investigation concluded that for certain vials in the affected lot, the potential exists for a crack to have occurred in the vial. If the vial was cracked, the integrity of the vial and the sterility of any product remaining in the vial could not be assured. More information  Recall: Benztropine Mesylate Injection by Fresenius Kabi USA - Potential Presence Of Glass Particles Fresenius Kabi USA is voluntarily recalling four lots of Benztropine Mesylate Injection, USP, 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the potential presence of glass particles (glass delamination) in the vials. The defect discovered in this product was noted as visible particulate. However, the process of glass delamination may result in formation of visible and subvisible particles. No adverse events, patient reactions or customer complaints have been reported to date. More information Class I Recalls: Medtronic SynchroMed Implantable Infusion System Devices - Feed Through Failure, Failure of Priming Bolus, and Catheter Occlusion In June 2013, Medtronic, Inc. initiated four medical device notifications to customers worldwide about the SynchroMed Implantable Infusion System. FDA has classified three of these notifications as Class I recalls. The fourth notification is an update to a 2011 action related to pump refill which was previously classified by the FDA as a Class I recall.  More information  FDA Drug Safety Communication: Hydroxyethyl Starch Solutions - Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding FDA has analyzed recent data that indicate an increased risk of (i) mortality and renal injury requiring renal replacement therapy in critically ill adult patients, including patients with sepsis and those admitted to the ICU; and (ii) excess bleeding particularly in patients undergoing open heart surgery in association with cardiopulmonary bypass. More information Class I Recall: Medtronic Xomed NIM Trivantage EMG Endotracheal Tube- Cuff Leak or Cuff Deflation When Inflation Valve Cap Inappropriately Removed FDA notified healthcare professional of a Class I Recall of the Medtronic Xomed, Inc. NIM Trivantage EMG Endotracheal Tube. The firm received complaints of "cuff leak" or "cuff deflation" occurring when the inflation valve cap is inappropriately removed (pulled off, instead of snapped-off sideways). This requires the physician to re-inflate or replace the deflated tube to ensure the continued breathing support of the patient. Use of this recalled product can result in serious adverse health consequences, including death. More information Class I Recall: Respironics California, Inc. - V60 Ventilators - Issue with software  Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue with the software on the V60 Power Management Board Assembly. If a component fails on the Power Management Board Assembly, it may cause ventilator support to be lost with potentially no audible alarm from the ventilator. This recalled product may cause serious adverse health consequences, including death. 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 the first non-hormonal treatment for hot flashes associated with menopause FDA  approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA. More information    FDA approves Vibativ for hospitalized patients with bacterial pneumonia FDA  expanded the approved use of the antibiotic Vibativ (telavancin) to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus. Vibativ should be used for the treatment of HABP/VABP only when alternative treatments are not suitable. More information FDA approves Plan B One-Step emergency contraceptive for use without a prescription for all women of child-bearing potential Today, the U.S. Food and Drug Administration announced it has approved the use of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the United States District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions. 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: New Approaches to Antibacterial Drug Development 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 Comments: 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: Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices FDA is seeking public comment on how to implement the drug supply chain provisions found in Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Under Title VII FDA is authorized to require that importers submit information demonstrating that their drug complies with applicable requirements of the Federal Food, Drug and Cosmetic Act before their products can enter the U.S. In addition, commercial importers must register with FDA and meet good importer practices. Comments are due by August 12, 2013. More information Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics; Availability The purpose of this draft guidance is to provide a single resource for information on FDA's policies and procedures related to expedited drug development and review programs. The following programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of serious or life-threatening conditions (expedited programs): Fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. Comments are due by August 26, 2013. More information Request for Comments: Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research FDA is establishing a public docket for interested parties to submit to FDA comments on the Institute of Medicine’s (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research. FDA is interested in receiving information on whether some form of third-party governance should be considered for other types of industry-sponsored tobacco product research, including research to support premarket tobacco product applications and other submissions to FDA, as well as research designed to contribute to general knowledge regarding tobacco products. Comments are due by September 30, 2013. More information  ANNOUNCEMENTS FDA takes action to protect consumers from dangerous medicines sold by illegal online pharmacies FDA  in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. These actions include the issuance of regulatory warnings, and seizure of offending websites and $41,104,386 worth of illegal medicines worldwide. More Information  Consumer Update: Use Sunscreen Spray? Avoid Open Flame FDA has become aware of five separate incidents in which people wearing sunscreen spray near sources of flame suffered significant burns that required medical treatment. You should never apply a product labeled as flammable while you are near a source of flame. More information  FDA announces first decisions on new tobacco products through the substantial equivalence pathway For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence (SE) pathway. Under the law, one way manufacturers can legally sell a new tobacco product is to establish that their product is substantially equivalent to a valid predicate product already on the market. More information Consumer Update: Protect Yourself Against Tick-Borne Disease Different kinds of ticks present in the U.S. may be infected with bacteria, viruses and parasites that can be transmitted to people and cause at least 10 diseases. While there are treatments approved by the FDA, prevention s the easiest, cheapest and most effective approach to combat these serious, sometimes fatal disease. More information  BeSafeRx: Know Your Online Pharmacy FDA BeSafeRx is a national campaign to raise awareness of the dangers of buying prescription medicines from fake online pharmacies. This campaign provides the resources to help consumers. More Information Continuing Education Program for Nurses Mark your calendar for the upcoming July 18, 2013 continuing education program, “Best Practices for Safe Patient Handling and Mobility: Standards & Technology”, a joint effort of the American Nurses Association and the U.S. Food and Drug Administration. 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. Cardiovascular and Renal Drugs Advisory Committee 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 Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices (Jul 12) FDA is announcing a day-long public meeting to discuss how to implement the drug supply chain provisions found in Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012. Under Title VII FDA is authorized to require that importers submit information demonstrating that their drug complies with applicable requirements of the Federal Food, Drug and Cosmetic Act before their products can enter the U.S. In addition, commercial importers must register with FDA and meet good importer practices. The purpose of the meeting is to provide an overview of Title VII, discuss how FDA plans to implement it and hear public comment about those provisions that specifically address imported drugs and importers. 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 Public Workshop: Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study (Jul 23) This workshop will introduce for discussion a new nonclinical paradigm for assessing TdP risk and explore the parameters for an appropriate, strong, nonclinical proarrthymia screening method as an alternative to clinical Thorough QT studies. The workshop is intended to provide a forum for stakeholders, including experts and opinion leaders from academia, industry, and regulatory agencies in the U.S., the European Union, Canada, and Asian countries, to discuss what a new framework might look like, the benefits and limitations of the current guidelines, and the importance of a uniform assay schema. 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 Scientific Workshop: Tobacco Product Analysis (Jul 30-31) The purpose of this scientific workshop is to obtain input on the chemical analysis of tobacco products. The analyses of tobacco products include developing test methods and evaluating method performance to ensure the results of the analyses are reliable and accurate. This scientific workshop will focus on understanding the testing of tobacco filler and smoke from cigarettes, roll-your-own (RYO) tobacco, and smokeless tobacco products for specific chemicals. More information Nonprescription Drugs Advisory Committee (Jul 31) The committee will discuss data submitted by sanofi-aventis U.S., LLC to support a supplemental new drug application (sNDA) 20468/S-035, for the switch from prescription to over-the-counter (OTC) of triamcinolone acetonide nasal spray. The proposed OTC use is “temporarily relieves these symptoms of hay fever or other upper respiratory allergies: Nasal congestion, runny nose, sneezing, itchy nose.” The applicant proposes to label the product for OTC use in adults and children. More information  Cardiovascular and Renal Drugs Advisory Committee (Aug 5) The committee will discuss new drug application 204441, tolvaptan tablets, for the proposed indication of slowing kidney disease in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease. More information  Cardiovascular and Renal Drugs Advisory Committee (Aug 6) The committee will discuss new drug application (NDA) 204819, proposed trade name ADEMPAS (riociguat coated tablet), submitted by Bayer HealthCare Pharmaceuticals Inc., for the treatment of: (1) Chronic thromboembolic pulmonary hypertension World Health Organization (WHO) Group 4 to improve exercise capacity and WHO functional class and (2) pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class, and to delay clinical worsening. 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