miércoles, 3 de agosto de 2016

August 3, 2016 - FDA Patient Network Newsletter

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Comfort Shield Barrier Cream Cloths
MedWatch Safety Information: Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination
Sage Products is voluntarily initiating a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and health care facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening.
This recall affects the following lot of Comfort Shield Barrier Cream Cloths: Product Code 7503; NDC Number 53462-915-50; Lot Number 53957; Expiration Date 3/6/2018. The affected lot was distributed to customers between March 31, 2016 and June 8, 2016. More information
Drug Safety
FDA updates warnings for fluoroquinolone antibiotics
FDA approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.
“Fluoroquinolones have risks and benefits that should be considered very carefully,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “It’s important that both health care providers and patients are aware of both the risks and benefits of fluoroquinolones and make an informed decision about their use.” More information
Gray Pointer
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


Empty Medicine Cabinet with Empty Medicine Bottle
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
Biologics and Vaccines Reported to be Resolved by Manufacturers During the Past 4 Weeks:
Drugs Reported to be Discontinued by Manufacturers During the Past 2 Weeks:

Gray Pointer
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 


Adlyxin
Adlyxin approved to treat type 2 diabetes
FDA approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, M.D., deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.” More information
For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.


What you think matters

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.


    Unique Voice of Our Patient Reps
    The Unique Voices of Our Patient Representatives, by: Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration and Heidi C. Marchand, Pharm.D., is Assistant Commissioner in FDA’s Office of Health and Constituent Affairs
    We recently met with 21 inspirational patients and patient caregivers who have made the extraordinary commitment to become FDA patient representatives. These volunteers were in Washington to participate in our two-day Patient Representative Workshop so they can receive training that will allow them to help FDA meet its critical responsibility of guiding the development and evaluation of safe and effective medical products.
    The patient representative program has existed since 1999 and is integral to fulfilling FDA’s strong commitment to ensure that the needs and choices of patients – as well as their families, caregivers, and advocates – are incorporated in ever greater ways in the work we do. To read the rest of the post, seeFDA Voice, July 28, 2016
    Submit Nomination
    Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
    FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization.
    FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups. More information and to submit your nomination
    Zika Virus
    Statement from Peter Marks, M.D., Ph.D., Director, FDA’s Center for Biologics Evaluation and Research
    The FDA is tasked with taking important steps to respond to Zika cases in the United States. One of the agency’s key public health responsibilities is to help ensure the safety of the nation’s blood supply.
    Recently, the Office of the Florida Department of Health State Surgeon General announced that it is conducting an epidemiological investigation into a number of non-travel related cases of Zika virus in Miami-Dade and Broward Counties. These may be the first cases of local Zika virus transmission by mosquitoes in the continental United States. Miami-Dade County and Broward Counties are adjacent counties in South Florida. More information


    FDA Public Meeting
    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.
    Diabetes Outcome
    Public Workshop: Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c)
    • August 29, 2016, from 9:00 a.m. to 5 p.m. 
    • The purpose of this public workshop is to have a forum for dialogue with the public, patients, patient advocacy groups and industry to gain greater appreciation on the extent to which the current regulatory paradigm for antidiabetic drug therapies addresses the needs of patients with diabetes and to identify additional outcomes, beyond HbA1c, that are of direct relevance and importance to patients living with the disease. More information
     View FDA's Patient Network Calendar of Public Meetings page for a complete list of meetings and workshops.
    Gray Pointer
    For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.


    Mercury Poison
    Mercury Poisoning Linked to Skin Products
    Whatever your complexion, it’s important to use products that will help your skin and not damage it. But as you wade through the beauty aisles, the U.S. Food and Drug Administration cautions that you should avoid skin creams, beauty and antiseptic soaps, and lotions that contain mercury.
    How will you know if mercury’s in the cosmetic, especially one that’s marketed as “anti-aging” or “skin lightening”? Check the label. If the words “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury” are listed on the label, mercury’s in it—and you should stop using the product immediately. 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


    Dietary Supplements
    Information for Consumers on Using Dietary Supplements
    Dietary Supplements can be beneficial to your health — but taking supplements can also involve health risks.
    Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. The Dietary Supplement Health and Education Act (DSHEA) of 1994, which amended the Federal Food, Drug, and Cosmetic Act, created a new regulatory framework for the safety and labeling of dietary supplements. FDA is not authorized to review dietary supplement products for safety and effectiveness before they are marketed.
    The following are resources and important information for you and your family about dietary supplements.

    Consumer Fact Sheets from FDA

    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


    Good Dog
    Good Dog, Bad Food: Foods for People That Are Bad for Your Dog
    If you consider the family dog, well, family—and are apt to toss him a piece of your food now and then—proceed with caution. Some foods meant for human consumption can be dangerous, and even deadly, to your dog.
    How are people and animals different when it comes to food?
    According to Carmela Stamper, D.V.M., a veterinarian at the U.S. Food and Drug Administration (FDA), an animal’s body processes food much differently. “Our bodies may break down foods or other chemicals that a dog’s can’t tolerate,” she says. More information
    Animal Health Literacy
    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
    Sick dog
    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


    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


    FDA Cosmetics
    What is a Cosmetic?
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.More information
    How to Report a Cosmetic Related Problem
    You can report a problem you have experienced with a cosmetic to FDA's MedWatch online or by call 1-800-FDA-1088. You can also contact the FDA district office consumer complaint coordinator for your geographic area.
    Recalls and Alerts
    To see safety alerts and  recent recalls related to cosmetics and other products regulated by FDA. More information


    Expanded Access Image
    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


    Resources for You
    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 Patient Network or  Take me to FDA Webinars and Presentations
    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
    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.
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