FDA Updates for Health Professionals

As part of our ongoing efforts to keep you informed about FDA, the Office of Health and Constituent Affairs (formerly the Office of Special Health Issues) 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. September 25, 2013 PRODUCT SAFETY W.S. Badger Company Daily SPF 30 Kids & Baby Sunscreen Lotion: Recall - Microbial Contamination Lab testing found certain product lots were contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi. More information Arzerra (ofatumumab) and Rituxan (rituximab): Drug Safety Communication - New Boxed Warning, Recommendations to Decrease Risk of Hepatitis B Reactivation Hepatitis B reactivation occurred in patients with prior HBV exposure and later treated with Arzerra & Rituxan. Cases of fulminant hepatitis, hepatic failure, and death reported. More information Public Notification: Xzen 1200, Xzen Gold and Xzen XPress - Undeclared Ingredients Contains contains sildenafil and tadalafil, which may interact with nitrates found in some prescription drugs lower blood pressure to dangerous levels. More information Public Notification: XZone Premium - Undeclared Drug Ingredient Contains contains sildenafil and tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. More information Public Notification: Wood-E - Undeclared Drug Ingredient Contains sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. More information Drug Safety Communication: Duragesic (fentanyl) Patches - Packaging Changes to Minimize Risk of Accidental Exposure Accidental exposure to fentanyl can cause serious harm and death in children, pets, and others. More information Recall: Baxter Dual Luer Lock Caps - Presence of Loose Particulate Matter Found In Packaging May result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke. More information Public Notification: Shou Fu Ti Tun Guo Xiang Xing Jian Fei Jiao Nang - Undeclared Drug Ingredient May substantially increase blood pressure and/or pulse rate in some patients and presents a risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. More information Recall: HeartSine Technologies Samaritan 300/300P PAD Public Access Defibrillators - Power, Battery Issues Two separate issues may affect the ability to deliver therapy to a patient in a sudden cardiac arrest event.  More information Recall: Bupivacaine HCL Injection 0.25% (2.5 MG/ML) and Bupivacaine HCL 0.75% (7.5 MG/ML), 30 ML Single-Dose Vials by Hospira, Inc. - Presence of Particulate Matte One lot of each strength recalled, administration of an injectable with the presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, and/or endocarditis and death may result.  More information Drug Safety Labeling Changes - August 2013 Includes 34 products with revisions to Prescribing Information. More information Recall: Creafuse Powder Grape and Creafuse Powder Fruit Punch - Contains DMAA Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. 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 approval expands access to artificial heart valve for inoperable patients FDA approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart. More information FDA approves first generic capecitabine to treat colorectal and breast cancers FDA approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat cancer of the colon or rectum (colorectal cancer) that has spread to other parts of the body (metastatic), and metastatic breast cancer. Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150 and 500 milligram strengths. More information New medical device treats urinary symptoms related to enlarged prostate FDA authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate. 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 Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format This draft guidance provides recommendations for the "Patient Counseling Information" section on the following: How to decide what topics to include in the section, how to present information within the section, and how to format and organize section contents. Submit either electronic or written comments on the draft guidance by November 18, 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 Webinar:  New Draft Guidance for Industry - Antibacterial Therapies for Patients with Unmet Medical Need for the Treatment of Serious Bacterial Diseases This webinar will provide an opportunity to learn about the guidance from individuals involved in its preparation. It is also intended to encourage the submission of questions or comments while the guidance is still in draft form. It will be held Friday, September 27 from 1:00 PM - 2:00 PM (EDT). More information FDA issues final guidance on mobile medical apps FDA has issued a guidance document to give mobile app creators a clear and predictable roadmap to help them determine whether or not their products will be the focus of FDA's oversight. To protect consumers and encourage innovation, while at the same time providing the same level of confidence consumers have with other medical devices, the guidance document states that FDA will focus its oversight on medical mobile apps that meet the definition of device in the Federal Food, Drug, and Cosmetic Act. FDA hosted a stakeholder teleconference on this topic on Sept. 23.  A replay is available until October 23. To hear the replay, callers can dial 888-562-6809. More information FDA awards seven grants to stimulate development of pediatric medical devices FDA announced it has awarded seven grants totaling more than $3.5 million to various pediatric device consortia to boost the development and availability of medical devices for children. More information FDA finalizes new unique device identifier (UDI) system for medical devices The UDI system consists of two core items. The first is a unique number assigned by the device manufacturer to the version or model of a device, called a unique device identifier. This identifier will also include production-specific information such as the product's lot or batch number, expiration date, and manufacturing date when that information appears on the label. The second component is a publicly searchable database administered by the FDA, called the Global Unique Device Identification Database (GUDID) that will serve as a reference catalogue for every device with an identifier. More information FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science FDA and NIH as part of an on-going interagency partnership, have awarded a total of up to $53 million to fund tobacco-related research in fiscal year 2013 to create 14 Tobacco Centers of Regulatory Science (TCORS). 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. Third Annual Food and Drug Administration Health Professional Organizations Conference (Oct 24) Topics on the agenda include FDA Updates, an overview of FDA's Network of Experts (public/private partnerships), and a FDA Town Hall. More information Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop (Oct 7) The purpose of the public workshop is to bring together a broad range of stakeholders to discuss current and future standards development activities involving cellular therapies and regenerative medicine products. More information  Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Oct 8-9) The committee will discuss, make recommendations, and vote on devices indicated for use in patients with heart failure (HF). More information FDA/American Academy of Ophthalmology Public Workshop on Developing Novel Endpoints for Premium Intraocular Lenses (Oct 11) The main topic of this workshop is the current challenges in the assessment of innovative intraocular lens (IOL) designs with a focus on endpoint methodologies used in evaluating IOL safety and effectiveness. More information Endocrinologic and Metabolic Drugs Advisory Committee Meeting (Oct 16) The committee will discuss the supplemental new drug application, Vascepa (icosapent ethyl) Capsules. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase to reduce triglycerides, non-high-density lipoprotein cholesterol, apolipoprotein B, low-density lipoprotein cholesterol, total cholesterol and very-low-density lipoprotein cholesterol in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent. More information Anti-Infective Drugs Advisory Committee Meeting (Oct 17) The purpose of the meeting is to discuss susceptibility interpretive criteria for systemic antibacterial drugs and for dosing recommendations in product labeling. We will seek input on the role of pharmacokinetic data in setting susceptibility interpretive criteria. We will also discuss revising dosing recommendations in product labeling based on pharmacokinetic data and clinical safety and efficacy data. More information Anti-Infective Drugs Advisory Committee Meeting (Oct 18) The committee will discuss the safety and effectiveness of new drug application, miltefosine capsules,  for the proposed indication of treatment of patients with visceral, mucosal, and cutaneous leishmaniasis, an infection caused by a parasite. More information Public Workshop: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (Oct 21-22) FDA Center for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the American Gastroenterological Association, the Crohn's and Colitis Foundation of America, Inc., the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD Foundation, is announcing a 2-day public workshop entitled "Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II)." Partners and stakeholders planning the workshop also include patients and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. More information Cellular, Tissue and Gene Therapies Advisory Committee (Oct 22-23) The Committee will discuss oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. The Committee will also hear updates on guidance documents issued from the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, and discuss considerations for the design of early-phase clinical trials of cellular and gene therapy products. More information Antiviral Drugs Advisory Committee Meeting (Oct 25) The committee will discuss new drug application (NDA) 204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by Gilead Sciences, Inc., with a proposed indication for the treatment of chronic hepatitis C infection, in combination with other agents in adult patients with genotypes 1 to 6 and/or adult patients awaiting liver transplantation. More information Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products (Oct 29) Stakeholders, including industry sponsors, academia, patients receiving parenteral nutrition, and FDA, will discuss challenging issues related to selection of endpoints and assessment methodologies in registration trials. Trial design strategies and possible candidates for endpoints will be explored. More information Blood Products Advisory Committee Meeting (Nov 1) The committee will meet in open session to discuss MP Biomedicals' biologic license application for the MP Diagnostics HTLV Blot 2.4, a Western Blot intended for use as a confirmatory test for blood donors.  In the afternoon, the committee will hear update presentations on the following topics:  (1) The April 2013 FDA public workshop on multiplex detection of transfusion transmissible agents and blood cell antigens in blood donations and (2) FDA safety communications on new boxed warnings for immune globulin products and hydroxyethyl starch solutions. More information Allergenic Products Advisory Committee Meeting (Nov 5-6) On November 5, 2013, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of Oralair, manufactured by Stallergenes. On November 6, 2013, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of Grastek, manufactured by Merck.More information  Public Hearing: Over-the-Counter Ophthalmic Drug Products-Emergency Use Eyewash Products (Dec 4) The purpose of the public hearing is to obtain information on the formulation, manufacturing, and labeling of currently marketed over-the-counter (OTC) emergency first aid eyewash drug products, including the components of these products, and the conditions under which such products are safe and effective for their intended uses. More information Public Meeting: Fibromyalgia - Patient-Focused Drug Development (Dec 10) Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of fibromyalgia on daily life as well as the available therapies for fibromyalgia. 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

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