miércoles, 16 de marzo de 2016

OHCA Patient Network Newsletter: March 16, 2016

March 16 NewsMasthead

Product Safety Bar
Loose safety seals
FDA warns consumers about potential risks of using eye drops packaged in bottles with loose safety seals
FDA is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used. The plastic safety seal or tamper-evident ring, also known as a collar, or band, should stay connected to the bottle neck. However, some eye drop bottles are losing the safety seals or rings when consumers tilt or squeeze the bottle to place eye drops into their eyes. A loose safety seal or ring presents a safety risk as it may cause eye injuries. Consumers and health care providers who have these products should not attempt to remove the ring or seal because there is a potential to contaminate the tip of the dropper. More information

Dietary Supplements II
Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You
If you buy imported products marketed as “dietary supplements” and nonprescription drug products from ethnic or international stores, flea markets, swap meets or online, watch out. Health fraud scams abound. According to Cariny Nunez, M.P.H., a public health advisor in the Office of Minority Health at the Food and Drug Administration (FDA), health scammers often target advertising to people who prefer to shop at nontraditional places, especially those who have limited English proficiency and limited access to health care services and information.
FDA has created a video to educate consumers about supplement safety. The video is available in English, Spanish, Chinese (Mandarin), Vietnamese, Tagalog, and Korean.
Health Fraud Scams
Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. Health fraud scams waste money and can lead to delays in getting proper diagnosis and treatment.They can also cause serious or even fatal injuries. Watch this video to learn more.

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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

MedWatch Report a Problem 2015

Product Shortages and Discontinuations
Empty Medicine Cabinet with Empty Medicine Bottle
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:
    Drug Shortages Reported to be Resolved by Manufacturers During the Past 2 Weeks:
    Drugs Reported to be Discontinued by Manufacturers During the Past 2 Weeks:

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    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 yprevenir la escasez de medicamentos. La escasez se produce por muchas razones, incluyendoproblemas 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 riesgosinvolucrados y evitar daños a los pacientes. La FDA también considera el impacto que una escaseztendría en la atención médica del paciente y al acceso del producto y trabaja con la empresa pararestablecer el suministro al tiempo que garantiza la seguridad de los pacientes. Más información 

    Product Approvals
    FDA Laboratory
    FDA approves first coagulation factor-albumin fusion protein to treat patients with hemophilia B
    FDA has approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX fusion protein product approved in the U.S. that is modified to last longer in the blood. “The approval of Idelvion provides another important therapeutic option for children and adults with Hemophilia B to help prevent or control bleeding and reduce the frequency of bleeding episodes,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. More information
    FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer
    FDA has approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. Xalkori is the first and only FDA approved treatment for patients with ROS-1 positive NSCLC. Lung cancer is the leading cause of cancer-related deaths in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. ROS-1 gene alterations, thought to lead to abnormal cells, have been identified in various cancers, including NSCLC. ROS-1 gene alterations are present in approximately 1 percent of patients with NSCLC. The overall patient and disease characteristics of NSCLC with ROS-1 gene alterations appear similar to NSCLC with anaplastic lymphoma kinase (ALK) gene alterations, for which crizotinib use was previously approved. Xalkori was approved to treat certain patients with late-stage NSCLC that expresses an abnormal ALK gene in 2011. More information
    FDA permits marketing of device that senses optimal time to check patient’s eye pressureFDA permits marketing of a one-time use contact lens that may help practitioners identify the best time of day to measure a patient’s intraocular pressure (IOP). Elevated IOP is often associated with the optic nerve damage that is characteristic of glaucoma. The Triggerfish has a sensor embedded in a soft silicone contact lens that detects tiny changes or fluctuations in an eye’s volume. The device is worn for a maximum of 24 hours, transmitting data wirelessly from the sensor to an adhesive antenna worn around the eye. A portable data recorder worn by the patient receives information from the antenna and can transfer the data via Bluetooth to the clinician’s computer, which shows the range of time during the day the pressure of the eye may be increasing. The device does not actually measure IOP, is not intended to be a diagnostic tool and is not used to correct vision. More information
    For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.

    Opportunities for Comment
    Father and Son at Computer
    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.

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    Follow us on Twitter
    The Patient Network is pleased to announce that we now have our own Twitter account! Please follow us for the latest patient related info/updates @FDA_Patient_Net
    Gayatri Rao Natural History Video
    FDA releases a Video Discussion on the Natural History Studies for Rare Diseases 
    The Discussion brings together patients and FDA perspectives on the importance of natural history studies in the development of products for rare diseases. Watch theVideo Discussion.
    FDA and DOJ take action against Virginia soybean business for selling contaminated sprouts
    The United States District Court for the Eastern District of Virginia entered a consent decree of permanent injunction between the United States and Henry’s Farm, Inc., located in Woodford, Virginia, and its owner Soo C. Park, after the U.S. Food and Drug Administration documented multiple violations of federal food safety laws and regulations. The consent decree prohibits Henry’s Farm, Inc. from receiving, processing, manufacturing, preparing, packing, holding and distributing ready-to-eat soybean and mung-bean sprouts. The U.S. Department of Justice sought the consent decree on behalf of the FDA. More information

    Upcoming Meetings
    Advisory Committee Meeting
    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: Patient-Focused Drug Development for Psoriasis
    Date: March 17, 2016
    FDA is conducting a public meeting on Patient-Focused Drug Development for Psoriasis. FDA is interested in obtaining patient perspectives on the impact of psoriasis on daily life, patient views on treatment approaches, and decision factors taken into account when selecting a treatment. FDA is interested in patient's perspectives for the types of psoriasis with primarily skin symptoms (such as plaque psoriasis, nail psoriasis, guttate psoriasis, etc.) More information 

    Public Workshop: Advancing the Development of Pediatric Therapeutics (ADEPT) - Successes and Challenges of Performing Long-Term Pediatric Safety Studies
    Dates: April 13 & 14, 2016
    The purpose of this two day workshop is for FDA to have an open discussion with experts in the field regarding the length of pediatric safety studies. Day 1 will focus on an exposition of the successes and challenges of long-term safety studies in children. Day 2 will focus on suggestions for the future on study design and implementation for long-term safety studies in children. Viewpoints of patient representatives of children with long-term conditions and industry will be included. More information
    Public Meeting: Childhood Cancer Advocacy Forum 2016
    Date: April 22, 2016
    The purpose of this meeting is to discuss: update of cancer drugs approved for pediatric use, Best Pharmaceuticals for Children Act (BPCA)/Written Request (WR) study results which have informed product labeling, Pediatric Research Equity Act (PREA), and initial pediatric study plans (iPSP) for oncology drugs - impact on issuance of WRs, expanding patient-focused drug development to children with cancer and pediatric patient reported outcomes (PROs), Expanded Access to investigational drugs, expanding eligibility criteria for clinical trials to accommodate early evaluation of certain products in children, and promising new vaccine and engineered cell products for cancer. More information
    View FDA's Calendar of Public Meetings page for a complete list of meetings and workshops.
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    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.

    Consumer Updates
    Sleep apnea machine
    Always Tired? You May Have Sleep Apnea
    Your spouse says your snoring is driving her nuts. You wake up feeling unrested and irritable. These are common signs that you may have obstructive sleep apnea (OSA), a sleep disorder that—left untreated—can take its toll on the body and mind. Untreated OSA has been linked to high blood pressure, heart attacks, strokes, car accidents, work-related accidents and depression. According to the American Sleep Association, OSA affects more than 12 million Americans. FDA ensures the safety and effectiveness of medical devices, including the device most often used by those affected by OSA – the Continuous Positive Airway Pressure machine, commonly known as CPAP – and a new device, the Inspire Upper Airway Stimulation (UAS) System.More information
    Vaccine development in lab
    FDA Researchers Advance Science for Vaccines to Prevent Mumps and Whooping Cough
    In a light-filled lab at FDA, a collection of small containers are growing the bacteria that cause whooping cough. In a nearby lab, cultures of the mumps virus also are being grown for studies aimed at improving the effectiveness of the mumps vaccine. This work is being done because reported cases of mumps and whooping cough (also called “pertussis”) have risen in recent years, even though many people are vaccinated. As part of the FDA’s commitment to protect the public health, researchers are seeking to better understand why these outbreaks occur. They’re working to figure out how to make current U.S. vaccines—which are already safe and effective—even better. And they’re reminding consumers that vaccination is still the best protection from these diseases and their potentially serious complications. 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

    Food Safety
    Dish of Pistachios
    FDA Investigates Multistate Outbreak of Salmonella Montevideo Linked to Pistachio Nuts Produced by Wonderful Pistachio and Almond
    The FDA, CDC, state and local officials are investigating a multi-state outbreak of Salmonella Montevideo illnesses linked to pistachio nuts produced by Wonderful Pistachios, located in Lost Hills, California. What Specific Products were Recalled? TheCDC reports that 11 people infected with the outbreak strain of Salmonella Montevideo have been reported from nine states: Alabama (1), Arizona (2), Connecticut (1), Georgia (1), Michigan (1), Minnesota (1), North Dakota (1), Virginia (1), and Washington (2). Two people have been hospitalized. There have been no deaths. Reported illness onset dates range from December 12, 2015 to February 9, 2016. More information
    Texas Star Nut and Food Co., Inc. Voluntarily Recalls Nature's Eats, Natural Pistachio Kernels Due To Possible Salmonella Contamination
    Texas Star Nut and Food Co., Inc. voluntarily recalls Nature’s Eats, Natural Pistachio Kernels, 8oz. – cello bag, with the lot code 40262001 and best by date of 1/4/2017 because of a possible health risk. The above product has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. More information
    Texas Star Nut & Food Company Expands Voluntarily Recall to Products Containing Pistachio Kernels Due To Possible Salmonella Contamination
    See additional list of recalled products
    Kanan Enterprises Conducts Nationwide Voluntary Recall of Natural in Shell Pistachios
    Kanan Enterprises announces the voluntary recall of natural in shell pistachios due to potential contamination with salmonella. Our third party supplier who makes this product has asked us to issue this recall because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. The only item that is affected by this recall is Favorites Natural Pistachios, a 4.5 ounce stand up pouch bag with a UPC 0 38445 12286 5 and a date code of 15 Feb 2017 and 16 Feb 2017. More information

    Awareness Voluntary Recalls Boost Tea Due To Possible Salmonella Contamination
    Awareness Corp. of Mesa, AZ, is recalling its 7.4 ounce container of Boost Tea because it may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream area and producing more severe illnesses such as arterial infections, endocarditis and arthritis. More information
    Nestlé USA Announces Voluntary Recall of a Limited Number of DiGiorno® Pizzas, Lean Cuisine® and Stouffer’s® Products Due to the Potential Presence of Foreign MaterialNestlé USA is initiating a voluntary recall of a limited number of DiGiorno®, Lean Cuisine®, and Stouffer’s® products due to the potential presence of glass pieces. The voluntary recall is limited to certain production codes, which can be found on the side panel of the package. More information, including affected production codes
    Food Safety
    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
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    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 ComplaintYou 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

    Tobacco Products
    Public Health Education
    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.
    Public Education CampaignsWe 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 TobaccoWe 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

    Expanded Access Bar
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    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
    For Patients Logo
    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
    For Physicians
    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 On line Resource
    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
    New 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.

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