OHCA Patient Network Newsletter: April 27, 2016

This bi-weekly newsletter provided by the Office of Health and Constituent Affairs at the Food and Drug Administration (FDA) is intended to inform you of FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates. Subscribe or update your subscriber preferences. Drug Safety Communication: Fluconazole (Diflucan) - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy FDA is evaluating the results of a Danish study that concludes there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. FDA is also reviewing additional data and will communicate final conclusions and recommendations when the review is complete. The current FDA drug label states that data available from studies in people do not suggest an increased risk of problems during pregnancy or abnormalities in developing babies when women are exposed to a single 150 mg dose of oral fluconazole to treat vaginal yeast infections. However, high doses of oral fluconazole (400-800 mg/day) taken by pregnant women for much longer than a single dose have resulted in reports of abnormalities at birth. In the Danish study, most of the oral fluconazole use appeared to be one or two doses of 150 mg. More information Recall: Focus Diagnostics Laboratory Examination Kits - Inaccurate Test Results Focus Diagnostics is recalling Simplexa Herpes Simplex Virus 1 & 2 Direct and Simplexa Group A Strep Direct kits containing the Direct Amplification Discs due to poor lamination between the sample reaction wells. This poor lamination may lead to leakage into adjacent wells causing cross-contamination between samples, which could yield false positive, false negative, or invalid test results. Inaccurate diagnostic test results may lead to improper patient treatment for HSV or GAS and 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 importante sobre seguridad de los medicamentos 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 inglés y la de 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 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 Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks: Bleomycin Sulfate for Injection Drugs Reported to be Discontinued by Manufacturers During the Past 2 Weeks: Fluphenazine Tablets  More information about drug shortages, drug shortages resolved, and drugs to be discontinued Information about blood and biologic shortages, resolved shortages, and discontinuations La FDA reconoce las consecuencias significativas para la salud pública que pueden resultar de la escasez de medicamentos y hace un gran esfuerzo dentro de sus facultades  legales para abordar y prevenir la escasez de medicamentos. La escasez se produce por muchas razones, incluyendo problemas de fabricación y calidad, retrasos y discontinuación del producto. Cuando los problemas son descubiertos por la empresa o el público y reportados a la FDA o se descubren por inspecciones de la FDA, la FDA trabaja en estrecha colaboración con la empresa para hacer frente a los riesgos involucrados y evitar daños a los pacientes. La FDA también considera el impacto que una escasez tendría en la atención médica del paciente y al acceso del producto y trabaja con la empresa para restablecer el suministro al tiempo que garantiza la seguridad de los pacientes. Más información FDA approved cabozantinib for treatment of advanced renal cell carcinoma patients who have received prior anti-angiogenic therapy FDA has approved cabozantinib (CABOMETYX, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The approval was based on a randomized study in which patients with advanced renal cell carcinoma who had received prior anti-angiogenic therapy received either cabozantinib 60 mg orally once daily (N=330) or everolimus 10 mg orally once daily (N=328). The primary endpoint was progression-free survival among the first 375 randomized subjects. Median progression-free survival in this group was 7.4 and 3.8 months in the cabozantinib and everolimus arms, respectively [HR 0.58 (95% CI: 0.45, 0.74); p<0.0001]. Median overall survival in the intent-to-treat population was 21.4 and 16.5 months in the cabozantinib and everolimus arms, respectively [HR 0.66 (95% CI: 0.53, 0.83); p=0.0003]. Confirmed response rate was 17% (95% CI: 13, 22) in the cabozantinib arm and 3% (95% CI: 2, 6) in the everolimus arm. More information FDA approves folic acid fortification of corn masa flour FDA has approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains. Folic acid, a synthetic form of folate, is a B vitamin that when taken by a pregnant woman may help prevent neural tube defects, which are birth defects affecting the brain, spine, and spinal cord. Pregnant women with folate deficiency have a higher risk of giving birth to infants affected with neural tube defects. More information For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed. View FDA's Comments on Current Draft Guidance page, for a list of current draft guidances and other topics of interest for patients and caregivers. Opportunities to Comment Closing April 2016 Opportunities to Comment Closing May 2016 Opportunities to Comment Closing June 2016 National Drug Take Back Day: A Great Time to Dispose of Prescription Medications Cluttering Your Cabinets, by Douglas C. Throckmorton, M.D., Deputy Center Director for Regulatory Programs in FDA's Center for Drug Evaluation and Research On Wednesday, April 27, FDA staff can bring in their unwanted, unused, or expired prescription drugs to the FDA campus for safe disposal as part of the Drug Enforcement Administration's (DEA) National Prescription Drug Take Back Initiative. In past years, we've collected more than 200 pounds of unused medications that would have otherwise lingered in medicine chests and kitchen cabinets. FDA's event is in advance of National Drug Take Back Day, marked on April 30. Medicines no longer being used may pose grave and unnecessary dangers to families and the people visiting their homes. For example, in the last two decades, FDA has received more than 30 reports of accidental exposure to the powerful pain medication in fentanyl patches – most of them in children under two years old. Tragically, 12 of these incidents required hospitalization and another 12 were deadly. Drug Take Back programs are the preferred method for fentanyl patch disposal and frequent drug take back programs run by local communities are a big step toward preventing unnecessary deaths due to accidental medication exposure. To read the rest of this post, see FDA Voice Blog, April 25, 2016. CDER Conversations: FDA's Breakthrough Therapy Designation and Expedited Review Programs For more than two decades, CDER has employed expedited pathways aimed at speeding the drug development and review processes so that therapies that show early promise can reach patients faster. The popularity and value of these programs has grown so much during this time that over half of CDER's 2015 novel drug approvals received some form of expedited review. In this two part interview, Dr. Rich Moscicki takes a deep dive into FDA's Breakthrough Therapy designation to help clarify common misunderstandings around this expedited program. Dr. Moscicki also breaks down each of CDER's expedited pathways to help readers understand not only the lingo, but also the implications of expedited reviews and approvals. PART I – FDA's Breakthrough Therapy Designation FDA's Breakthrough Therapy Designation and Expedited Review Programs: Part II What We Mean When We Talk About EvGen Part I: Laying the Foundation for a National System for Evidence Generation, by Rachel E. Sherman, M.D., M.P.H., FDA's Associate Deputy Commissioner for Medical Products and Tobacco; and Robert M. Califf, M.D., FDA Commissioner Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current paradigm of generating the scientific evidence that supports medical product evaluation and clinical care decisions and the need to modernize methods and expectations surrounding this evidence base. We know, for instance, that most clinical practice guideline recommendations are not based on high-quality evidence, typically derived from appropriately designed randomized controlled trials. We also know that adherence to standards supported by such high-quality evidence results in better outcomes for patients. There is reason to believe that we've arrived at a tipping point where previously separate, "siloed" efforts can be linked to create a national system for evidence generation (EvGen). In this first of a series of posts, we'll take a look at the elements required to build such a national system, beginning with a pair of foundational concepts—interoperability and connectivity. To read the rest of this post, see FDA Voice Blog, April 19, 2016. FDA proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior FDA has announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that cannot be corrected or eliminated through changes to the labeling. The FDA takes the act of banning a device only on rare occasions when it is necessary to protect public health. ESDs administer electrical shocks through electrodes attached to the skin of individuals to attempt to condition them to stop engaging in self-injurious or aggressive behavior. Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including depression, anxiety, worsening of self-injury behaviors and symptoms of posttraumatic stress disorder, pain, burns, tissue damage and errant shocks from a device malfunction. In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain or consent. As these risks cannot be eliminated through new or updated labeling, banning the product is necessary to protect public health. 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. Public Meeting: Neuropathic Pain Associated with Peripheral Neuropathy Patient-Focused Drug Development Date: June 10, 2016 The purpose of the meeting is to gather patients' perspectives on symptoms and daily impacts that matter most to them, and to discuss current treatment options. This meeting is an exciting opportunity for patients to bring their voice to FDA and the drug development process. More information View FDA's Calendar of Public Meetings page for a complete list of meetings and workshops. Calendar of FDA Sponsored Public Meetings - April 2016 Calendar of FDA Sponsored Public Meetings - May 2016 Calendar of FDA Sponsored Public Meetings - June 2016 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. Biosimilars: More Treatment Options Are on the Way The medical marketplace is about to get bigger. FDA has approved a second biosimilar product—Inflectra (Infliximab-dyyb), a biosimilar to Remicade (infliximab)—and expects to approve other biosimilars in the future. The FDA approved Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), in March 2015. What are biosimilars? To understand that it helps to first know what biological products (biologics) are, says Leah Christl, Ph.D., Associate Director for Therapeutic Biologics at FDA. Biologics are medicines that generally come from living organisms, which can include humans, animals and microorganisms such as yeast and bacteria. 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 En Español La información en esta página es para el público en general, y para profesionales y educadores de salud. Esta información puede ser distribuida y publicada sin previa autorización. En Español Listeriosis in Pregnant Women Listeriosis is a serious disease caused by eating foods that are contaminated with the Listeria monocytogenes ("Listeria") bacterium. This germ is commonly found in soil, water, decaying vegetation, and the intestinal tract of animals. It can also be found in soft cheeses or other products made from unpasteurized milk and processed foods that become contaminated such as deli meats. Unlike many other foodborne bacteria, Listeria grows in the refrigerator. Heat processes like pasteurization destroy Listeria. For pregnant women, the key is to avoid cheeses and other foods made from unpasteurized milk. If a pregnant woman contracts listeriosis, she can suffer severe consequences including pre-term labor or the loss of her baby. Read more in Consumer Brochure Center 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        Happy Retirement, Kathy! 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 and Publicaciones en Español del Animal and Veterinary Updates Animal and veterinary updates provide information to keep your pets healthy and safe. More information How to Report a Pet Food Complaint You can report complaints about a pet food product electronically through the Safety Reporting Portal or you can call your state's FDA Consumer Complaint Coordinators. Please provide as much information as possible in your complaint, such as exact name of product, type of container, lot number, UPC codes, how the food was stored, and purchase date and exact location where purchased. If possible, please save the original packaging until the pet food has been consumed. The packaging contains IMPORTANT information often needed to identify the variety of pet food, the manufacturing plant, and the production date. More information FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens FDA has announced it is expanding its award-winning "The Real Cost" campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless tobacco use. For the first time, messages on the dangers of smokeless tobacco use – including nicotine addiction, gum disease, tooth loss, and multiple kinds of cancer – are being highlighted through the placement of advertisements in 35 U.S. markets specifically selected to reach the campaign's target audience. "Not only is the target audience using smokeless tobacco at a high rate, but many do not fully understand the negative health consequences of their actions," said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products. "In communities where smokeless tobacco use is part of the culture, reaching at-risk teens with compelling messaging is critical to help change their understanding of the risks and harms associated with smokeless tobacco use." More information Public Health Education Tobacco products are harmful, yet widely used, consumer products that are responsible for severe health problems in both users and non-users. These health problems include cancer, lung disease, and heart disease, which often lead to death. Access the latest Health Information available from our Federal partners. Learn about Tobacco-Related Health Fraud. Public Education Campaigns We are investing in a number of public education campaigns, such as Fresh Empire and  The Real Cost, to help educate the public – especially youth – about the dangers of regulated tobacco products. Rooted in science, these efforts are directly linked to our authority to regulate the marketing and sales of tobacco products. More information Youth and Tobacco We are working to protect the health of America's children and ultimately reduce the burden of illness and death caused by tobacco use. More information Information about Expanded Access Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by FDA). FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices. More information Learn about what your physician should do before submitting a request for individual patient expanded access use of an investigational medical product, who may be eligible for expanded access, associated costs, FDA contacts and more. Information for Patients Learn about your responsibilities under the expanded access pathway, how to submit a request for expanded access for an individual patient (including for emergency use), which forms to use, FDA contacts and more. Information for Physicians Patient Network Webinars Through our webinars and presentations, the Office of Health and Constituent Affairs brings information to you on many topics related to patient engagement, medical product (Drugs, Biologics, Devices) approval and medical product safety updates. More information 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 /más información FDA E-list Sign up for one of the FDA disease specific e-mail list that delivers updates, including product approvals, safety warnings, notices of upcoming meetings, and notices on proposed regulatory guidances. Diabetes Cardiovascular Disease HIV Hepatitis B and C You may wish to sign up for other email updates from the FDA - see other email updates. Patient Network - Bring Your Voice to FDA 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 Subscriber Services: Manage Preferences  |  Unsubscribe  |  Help with this service Stay Connected:   This email was sent to bsamad2007.adnan@blogger.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332)