Patient Network Newsletter- March 29, 2017

This bi-weekly newsletter from the Food and Drug Administration (FDA) Office of Health and Constituent Affair is intended to inform patients and patient advocates of FDA-related information on 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. Subscribe or update your subscriber preferences. FDA Medwatch- Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events The FDA is informing health care providers treating patients with Absorb GT1 Bioresorbable Vascular Scaffold (BVS) that there is an increased rate of major adverse cardiac events observed in patients receiving the BVS, when compared to patients treated with the approved metallic XIENCE drug-eluting stent. The FDA is working with Abbott Vascular, Inc. to conduct additional analyses to better understand the cause(s) of the higher cardiac event and device thrombosis rates in patients treated with BVS compared to the XIENCE stent. More information Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) FDA has updated its understanding of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) to reflect the agency's concurrence with the World Health Organization designation of BIA-ALCL as a rare T-cell lymphoma that can develop following breast implants. At this time, most data suggest that BIA-ALCL occurs more frequently following implantation of breast implants with textured surfaces rather than those with smooth surfaces. BIA-ALCL is a rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. The exact number of cases remains difficult to determine due to significant limitations in world-wide reporting and lack of global implant sales data. 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 knows the major public health consequences that can result from drug shortages. These shortages occur for many reasons including manufacturing and quality problems, delays and discontinuations. When issues are discovered, FDA works closely with the company 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 company to restore supplies while also ensuring safety for patients. More information Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks: Atropine Sulfate Injection Fentanyl Citrate (Sublimaze) Injection Potassium Chloride Injection Rocuronium Bromide Injection Drug Discontinuation Voluntarily Reported by Manufacturers During the Past 2 Weeks: Montelukast Sodium Oral Granules Risperidone Orally Disintegrating Tablets, USP 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 approves new drug to treat multiple sclerosis The FDA approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional.  "Multiple sclerosis can have a profound impact on a person's life," said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS." More information FDA approves new eczema drug Dupixent The FDA approved approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids. "FDA's approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease," said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research. "Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies." More information FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers The FDA approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy. "Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence. "Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation." More information FDA approves first treatment for rare form of skin cancer The FDA granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer. "While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence. "The scientific community continues to make advances targeting the body's immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies—even in rare forms of cancer where treatment options are limited or non-existent." According to the National Cancer Institute, approximately 1,600 people in the United States are diagnosed with MCC every year. While the majority of patients present with localized tumors that can be treated with surgical resection, approximately half of all patients will experience recurrence, and more than 30 percent will eventually develop metastatic disease. In patients with metastatic MCC, the cancer has spread beyond the skin into other parts of the body. More information FDA approves drug to treat Parkinson's Disease The FDA approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson's disease who are currently taking levodopa/carbidopa and experiencing "off" episodes. An "off" episode is a time when a patient's medications are not working well, causing an increase in Parkinson's symptoms, such as tremor and difficulty walking. "Parkinson's is a relentless disease without a cure," said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "We are committed to helping make additional treatments for Parkinson's disease available to patients." An estimated 50,000 Americans are diagnosed with Parkinson's disease each year, according to the National Institutes of Health, and about one million Americans have the condition. 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 - April 2017 Opportunities to Comment - May 2017 Opportunities to Comment - June 2017 This is Not a Test: RMAT Designation Goes Live By: Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research at the FDA The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples include genetically-modified cellular therapies, such as chimeric antigen receptor T-cells (CAR-T cells) and human tissues grown on scaffolds for subsequent use. These products hold great promise in addressing serious unmet medical needs. For example, data from a number of different published studies indicate the potential for CAR-T cells to treat certain relapsed or refractory blood cancers. Recognizing the importance of this field, Congress included several provisions related to regenerative medicine in the 21st Century Cures Act, signed into law on Dec. 13, 2016. Building on the FDA's existing expedited programs available to regenerative medicine products, one of these provisions established a new program to help foster the development and approval of these products: Regenerative Medicine Advanced Therapy (RMAT) Designation. To read the rest of this post, see FDA Voice Blog, March 21, 2017 There's still time to register! On April 6, 2017, FDA is conducting a public meeting on Patient-Focused Drug Development (PFDD) for Sarcopenia. FDA is interested in obtaining patient perspectives on the impact of Sarcopenia on daily life and patient views on treatment approaches. Date: April 6, 2017 Time: 1:00 p.m. - 5:00 p.m. Location: Tommy Douglas Conference Center, 10000 New Hampshire Avenue Silver Spring, MD 20903 Registration: To register for this meeting, visit:  Patient-Focused Drug Development Public Meeting for Sarcopenia Event Brite website.  Public Docket: In addition to providing input at the public meeting, stakeholders are invited to provide their perspectives on the discussion questions through the public docket. The docket closes on June 6, 2017. In this section you will find a comprehensive list of all the meetings that the FDA is involved with. The meetings may include advisory committee meetings, public workshops and public conferences that are seeking to hear from patients and caregivers. Most FDA meetings are free to the public and do not require the public to register.  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. Calendar of FDA Sponsored Public Meetings - April 2017 Calendar of FDA Sponsored Public Meetings - May 2017  View FDA's Patient Network Calendar of Public Meetings page for a complete list of meetings and workshops. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops. Would your child benefit from a Clinical Trial? You may have heard of clinical trials, and your doctor may even have suggested your child enroll in one. Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. If your child were to enroll in one, he or she could be offered a new treatment that may (or may not) be better than those already being used. By law, giving a study drug to children must provide a potential for clinical benefit that justifies the risk of taking the drug, and the children who participate must have the disease or condition being studied. Under limited circumstances, children may be exposed to the risks of a drug (or other intervention) that does not offer any clinical benefit, provided that the risks are sufficiently low and the information to be gained is important to understanding or improving the disease or condition. In addition, clinical trials yield important information on a drug's safety, dosing, and/or effectiveness. Together, this information forms the basis for FDA approval; in addition, it guides whatever information goes in the product label, including about the right dose to use for which patients. More information Colorectal Cancer: What You Should Know Last year in the United States, more than 136,000 people were diagnosed with—and more than 50,000 died from—colorectal cancer, according to the National Cancer Institute. It is the second leading cause of cancer-related deaths in the United States, striking some groups more often than others. The toll this disease takes on minorities is especially high, said Jonca Bull, M.D., director of FDA's Office of Minority Health. Populations with limited access to screening and early treatment die much more often from the disease—African Americans, Hispanics, and American Indians and Alaska Natives. But there is a way of confronting this hazard, she added: "Early detection, referral, and treatment can significantly reduce disparities in deaths from colorectal cancer." Screening Saves Lives Colorectal cancer usually starts from polyps or other precancerous growths in the rectum or the colon (large intestine). People with precancerous growths or signs of colorectal cancer don't always show symptoms. That's why screening is important—doctors can see and remove growths or suspicious tissue before they become cancerous. 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 The Safety Reporting Portal The Safety Reporting Portal (SRP) streamlines the process of reporting product issues to the Food and Drug Administration and the National Institutes of Health. Whatever your role, (manufacturer, health care professional, researcher, public health official, or concerned citizen), when you submit a safety report through this Portal, you make a vital contribution to the safety of America's food supply, medicines, and other products that touch us all. More information 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 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 FDA  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 Missed the inaugural issue of CTPConnect? FDA's Center for Tobacco Products (CTP) recently published its newest issue of CTPConnect, a plainspoken digest with the latest stories from the Center. Want the full experience? Sign up today to receive the next issue of CTPConnect and other important updates from CTP directly to your inbox. Center for Tobacco Products updated safety reporting portal CTP recently updated its Safety Reporting Portal, an online tool for reporting suspected problems with tobacco products. Whether you're a consumer, manufacturer, clinical investigator, or health professional, let FDA know about products that seem to be damaged, defective, contaminated, or that smell or taste wrong. More information and to report a safety concern online. FDA's LGBT Public Education Campaign Makes Headlines FDA's "This Free Life" Campaign was recently recognized at the annual Association of National Advertisers (ANA) Multicultural Marketing & Diversity Conference. Winning the Multicultural Award of Excellence in the LGBT category, FDA made its mark among other category winners such as Coca-Cola, Toyota, and McDonalds. Watch the Ad and learn more about FDA's "This Free Life" campaign! Share the image and support those who matter to you most! Do you know someone who could benefit from CTP's messages about tobacco? Sharing information about the health effects of tobacco has never been so easy. Simply save either image in this section and post it to your social media account, such as Facebook or Twitter. Bad reaction to a cosmetic? FDA needs to know What do you do if you have a reaction after using a cosmetic product? First, stop using the product and contact your healthcare provider. Next, please report it to FDA. Here's why that next step is so important: Cosmetic products aren't required by law to have FDA approval before they go on the market. Companies that market cosmetics have a legal responsibility to ensure product safety, but FDA can only take action if the product is shown to be unsafe after the product is on the market. And, because the law doesn't require cosmetic companies to share customer complaints or other safety information with FDA, voluntary reports from consumers and healthcare providers are one of the best ways for FDA to learn about any problems. Cosmetics include a range of products people use every day, such as moisturizers, makeup, shampoos and conditioners, face and body washes, deodorants, nail care products, hair dyes and relaxers, and tattoos. More information Recalls and Alerts To see safety alerts and  recent recalls related to cosmetics and other products regulated by FDA. More information What to watch for, how to report You can report an allergic reaction, a rash, redness, burn, hair loss, headache, infection, illness, or any other unexpected reaction, whether or not it required medical treatment. You can also report a bad smell, color change, or other sign of contamination. You can choose the way you'd prefer to report: Call an FDA Consumer Complaint Coordinator if you want to speak directly to a person about your problem. Complete an electronic Voluntary MedWatch form online. Complete a paper Voluntary MedWatch form that you can mail to FDA. 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 FDA Patient Network The FDA Patient Network contains a series of webpages, webinars and presentations on topics related to patient engagement, FDA regulations, understanding medical product (Drugs, Biologics, and Devices) approval and medical product safety updates, Take me to the FDA Patient Network , Follow us on twitter or take me to FDA Webinars. 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 Email Updates 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. 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)