FDA Product Safety News

Volume 3 | Number 20 | October 2, 2013

What’s Affected by the Government Shutdown? Below, find an overview of some of the government services and operations that will be impacted until Congress passes a budget to fund them again. For detailed information about specific activities at Federal agencies, please see federal government contingency plans. Vital services that ensure seniors and young children have access to healthy food and meals may not have sufficient Federal funds to serve all beneficiaries in an extended lapse. Call centers, hotlines and regional offices that help veterans understand their benefits will close to the public. Veterans’ compensation, pension, education, and other benefits could be cut off in the case of an extended  shutdown. Every one of America’s national parks and monuments, from Yosemite to the Smithsonian to the Statue of Liberty, will be immediately closed. More information Drug Safety Communication: Fentanyl Patch Can Be Deadly to Children FDA is requiring color changes to the writing on Druagesic (fentanyl) pain patches so they can be more easily seen. Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, FDA is issuing a Drug Safety Communication to warn patients, caregivers and health care professionals about the dangers of accidental exposure to and improper storage and disposal of the fentanyl patch. More informationDrug Safety Communication: Boxed Warning and new recommendations to decrease risk of hepatitis B reactivation with the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk. Both Arzerra and Rituxan are used to treat certain cancers of the blood and lymph system. Rituxan is also approved to treat other medical conditions, including rheumatoid arthritis. Both drugs suppress the body’s immune system. More information Drug Safety Communication: Tygacil – Increased risk of death FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk  of death when intravenous Tygacil is used for FDA-approved uses as well as for non-approved uses. These changes to the Tygacil Prescribing Information are based on an additional analysis that was conducted for FDA-approved uses after FDA issuing a Drug Safety Communication about this safety concern in September 2010. More information The Compounding Shop: FDA News Release – Lack of sterility assurance of drug products FDA alerted patients and health care providers that budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. FDA observed a 1000 mL bottle of budesonide solution from The Compounding Shop that contained visible, white, floating material. FDA identified that material as a fungus and is concerned that contamination may be present in other budesonide solution products from The Compounding Shop that may currently be on the market. More information Class 1 Recall: Two lots of Baxter Dual Luer Lock Caps due to presence of loose particulate matter found in packaging Baxter International Inc. announced today it has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke. There have been no reported complaints associated with this issue, however embolic events may not be easily attributed to such particulate matter. The root cause has been identified and resolved. FDA has designated this as a Class I recall. More information Recall: W.S. Badger Company Daily SPF 30 Kids & Baby Sunscreen due to Microbial Contamination W.S. Badger Co. Inc. notified the public that it is recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion  due to microbial contamination. The products were tested and found to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi. The affected lots include the following:   SPF 30 Baby Sunscreen Lotion 4oz (UPC: 634084490091&634084490114) Lot #’s 3024A, 3057B, 3063A, 3063B, 3132A, 3133A SPF 30 Kids Sunscreen Lotion (UPC: 634084490145 & 634084490169) Lot # 3164A More information Federal judge approves consent decree against Shamrock Medical Solutions Group FDA has announced that federal judge Algenon L. Marbley of the Southern District of Ohio has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs. Shamrock Medical repackages and distributes solid and liquid oral non-sterile drug products for human use to hospitals throughout the country. Recent FDA inspections found several violations at the facility, including failure by the quality control unit to fully follow its own quality control procedures and to examine packaged and labeled products to ensure correct labeling. The FDA has previously sent warning letters to Shamrock Medical for violating current good manufacturing practices (CGMP) and distributing incorrectly labeled drugs. 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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch. FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. More information   Drugs to be Discontinued Announced During Past 2 Weeks:   Sitagliptin and Simvastatin (Juvisync)             More information about drug shortages, drug shortages resolved, and drugs to be discontinued. Information about blood and biologic shortages, resolved shortages, and discontinuations   Perjeta for neoadjuvant breast cancer treatment approved FDA has granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer. Perjeta was approved in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer. HER2-positive breast cancers have increased amounts of the HER2 protein that contributes to cancer cell growth and survival. Perjeta’s new use is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at high risk of having their cancer return or spread (metastasize) or of dying from the disease. It is to be used in combination with trastuzumab and other chemotherapy prior to surgery and, depending upon the treatment regimen used, may be followed by chemotherapy after surgery. Following surgery, patients should continue to receive trastuzumab to complete one year of treatment. More information New drug to treat major depressive disorder approved FDA approved Brintellix (vortioxetine) to treat adults with major depressive disorder. Major depressive disorder (MDD), commonly referred to as depression, is a mental disorder characterized by mood changes and other symptoms that interfere with a person’s ability to work, sleep, study, eat and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person’s lifetime, although some may experience a single occurrence. More information For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed. FDA issues final guidance on mobile medical apps FDA has issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps. The agency intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended. More information View current opportunities for comment on topics of interest for patients and caregivers. FDA releases report – The Voice of the Patient: Chronic Fatigue Syndrome and Myalgic Encephalomyelitis On April 25, 2013, FDA held a public meeting to hear perspectives from patients with chronic fatigue syndrome (CFS) and myalgic encephalomyelitis (ME) about their disease, its impact on their daily life, and currently available therapies. CFS and ME is a serious disease or set of diseases for which there are currently no FDA-approved therapies. Read the ReportFDA finalizes new system to identify medical devices FDA has announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices. The UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups in the development of this rule. More information FDA awards seven grants to stimulate development of pediatric medical devices FDA has 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. A panel of experts with experience in the clinical, business, and regulatory aspects of pediatric device development reviewed applications for the grants, which will be administered by the FDA’s Office of Orphan Products Development. The grant recipients are:   James Geiger, M.D., University of Michigan Pediatric Device Consortium David Ku, M.D., Ph.D., Atlantic Pediatric Device Consortium Peter Kim, M.D., National Capital Consortium for Pediatric Device Innovation Rick Greenwald, Ph.D., New England Pediatric Device Consortium Yaniv Bar-Cohen, M.D., Southern California Center for Technology and Innovation in Pediatrics Matthew Maltese, M.S., Ph.D., Philadelphia Regional Pediatric Medical Device Consortium Pedro del Nido, M.D., Boston Pediatric Device Consortium More information 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. View a complete list of upcoming public meetings and workshops.     Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops. Innovations Expand Types of Seasonal Flu Vaccines Many of the projected 135-139 million doses of influenza vaccines being produced for this flu season for use in the U.S. are now available to consumers from six manufacturers licensed by FDA. A variety of flu vaccines, including some that were not available during past influenza seasons, are available this year. This includes a vaccine that protects against four strains of the virus—two strains of type A and two of type B—rather than the traditional protection against three strains—two of type A and one of type B. In addition, a vaccine that is produced by growing the virus in cells rather than in eggs will be available for use in people 18 years of age and older. Unlike eggs, cells can be frozen for later use to grow large volumes of cells for the production of vaccine. This could provide a faster start-up time of the manufacturing process for any unexpected need. More information More Consumer Updates For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information Artículos en Español Estos artículos para los consumidores incluyen información sobre la Administración de Medicamentos y Alimentos (FDA, Food and Drug Administration) y consejos para llevar una vida saludable. Artículos en Español Nutrition Information for Raw Fruits, Vegetables, and Fish In order to encourage retail stores that sell raw fruits, vegetables, and fish to participate in the voluntary point-of-purchase nutrition information program, FDA has created downloadable posters for printing. These posters show nutrition information for the 20 most frequently consumed raw fruits, vegetables, and fish in the United States. Copies of postersCenter for Food Safety and Applied Nutrition The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. More information   Food Facts for You The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information Animal Health Literacy Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information    CVM Pet Facts The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe. More information Have a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA FDA will select some of your questions to answer each month. Due to the volume of e-mails we receive, we won’t be able to answer each question in this format. We may edit your questions for brevity or clarity. More information    To read questions and answers, see MailBag. 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 Educational Videos FDA Food Safety and Modernization Act: An FDA Primer The Rulemaking Process: An FDA Primer What is Regulatory Science Taking Acetaminophen Safely   healthfinder.gov Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy. More information  Tobacco Products Resources for You Federal resources to help you quit using tobacco products and to help you learn more about youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics. More information           An interactive tool for educating patients, patient advocates, and consumers on how their medications – both prescription and over-the-counter ­– and medical devices move from the realm of idea to the realm of the marketplace. More information

FDA Product Safety News