jueves, 18 de agosto de 2016

August 17, 2016 - Patient Network Newsletter


drug alert
BioMerieux Recall
BioMerieux is recalling the NucliSENS® easyMAG® Magnetic Silica (MagSil) because of effects on nucleic acids extraction performance. MagSil is used to extract and purify genetic material from patient samples. Kits with the affected lots of the Magnetic silica have exhibited a decrease of extraction performance with certain downstream applications. The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.  More information.
Drug advertising
Ton Shen Health of Chicago Recall 
Ton Shen Health of Chicago, IL, is recalling its “DHZC-2” Tablets because they have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children. Lead poisoning can happen if a person is exposed to high levels of lead over short period of time. One illness has been reported to date in connection with this problem. More information.
Empty Vial
PharmaTech, LLC Recalls Liquid Products 
PharmaTech, LLC is voluntarily recalling all liquid products due to a potential risk of product contamination with Burkholderia cepacia. If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at risk patient population. This recall affects all liquid products from October 20, 2015 through July 15, 2016. More information.
Syringe and vials
Hospira, Inc. recalls 0.25% Bupivacaine Hydrochloride Injection 
Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, due to the presence of particulate matter. In the event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response. USP is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. More information.
Hand reaching for pill bottle
FDA finds drugs under investigation in the U.S. related to French BIA 10-2474 drug do not pose similar safety risks
The FDA, with information received from the European Medicines Agency (EMA) and the French national medicines agency (ANSM), has completed a comprehensive review of safety information relevant to the investigational new drug BIA 10-2474 and the potential implications for related drugs under investigation in the U.S. The Agency has found, based on the available information, that BIA 10-2474 exhibits a unique toxicity that does not extend to other drugs in the class, called fatty acid amide hydrolase (FAAH) inhibitors. 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 endruginfo@fda.hhs.govComunicaciones de la FDA
MedWatch Report a Problem 2015

Drug Shortages
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
Drug Shortages Voluntarily Reported 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 

Medical Product Approvals
FDA Approved
SUSTOL (Granicetron)  by Heron Therapeutics is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. 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.

    FDA Updates Guidance for Dietary Supplement Industry Safety Notifications 
    The FDA issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers. The FDA estimates that there are more than 55,600 dietary supplements on the market, and that 5,560 new dietary supplement products come on the market each year.
    Oversight of imported food
    Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United States
    FDA supports the use of seizure by the U.S. Customs Service under authority of 19 CFR 18.21(b) of articles regulated by FDA, which are offered under a Transportation and Exportation Entry (T & E), if certain conditions are met. Such conditions may be: the article poses a hazard to health, consists of gross filth, or represents a gross consumer fraud *or we have reason to believe the article may be offered for entry into the U.S. at a later date or that its routing might be deviated during transit.*More information.

    Meeting Image
    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.
     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.

    Consumer Update
    Medical Devices that Treat Obesity: What to Know
    If your health care provider finds that you’re overweight or obese, you’re not alone. More than 68 percent of U.S. adults are considered overweight, according to federal statistics. And close to 36 percent of those are considered obese.
    Obesity is linked to health issues like heart disease, diabetes, and high blood pressure. And since losing weight starts with healthy eating and exercise, your health care provider can give advice on lifestyle changes that can help.
    In general, when diet and exercise are not effective, weight loss treatments can include prescription medications, invasive surgery, and medical devices. All have risks and benefits. More information
    Needles and sharps image
    Vaccines for Children: Information for Parents and Caregivers 
    As parents and caregivers fill out a multitude of forms at the start of the school year, they may have questions about some requirements, including the vaccine schedule. According to Marion Gruber, Ph.D., director of the Office of Vaccines Research and Review at the FDA, vaccines are integral to get children off to a healthy start. FDA’s online resource, Vaccines for Children, A Guide for Parents and Caregivers, describes in more detail the types of routinely administered vaccines available for children, and answers many of the questions posed by parents and caregivers. More information.
    Washing hands
    Outsmarting Poison Ivy and Other Poisonous Plants 
    First comes the itching, then a red rash, and then blisters. These symptoms of poison ivy, poison oak, and poison sumac can emerge any time from a few hours to several days after exposure to the plant oil found in the sap of these poisonous plants. Poison ivy and other poison plant rashes can’t be spread from person to person. But it is possible to pick up the rash from plant oil that may have stuck to clothing, pets, garden tools, and other items that have come in contact with these plants. 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
    The Safety Reporting Portal 
    The Safety Reporting Portal (SRP) streamlines the process of reporting product issues to the FDA 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
    Hypothyroidism in Dogs: New FDA Treatment Available
    Hypothyroidism occurs when the thyroid gland doesn’t produce and secrete enough thyroid hormones. The thyroid gland is located in the mid-neck region near the voice box (larynx). In dogs, the thyroid gland is made up of two separate lobes that lie on either side of the windpipe (trachea). Thyroid hormones play a big role in metabolism and affect the function of many parts of the body. Hypothyroidism is the most common hormone imbalance in dogs and is usually caused by inflammation or shrinkage of the thyroid gland. Hypothyroidism is typically seen in middle-aged to older dogs and occurs more commonly in medium to large breed dogs. 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.
    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

    FDA's New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products 
    Tobacco use is the single largest preventable cause of disease and death in the United States. Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products. For background information on this milestone in consumer protection, see The Facts on the FDA’s New Tobacco Rule.
    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. 
    Tobacco Regulatory Science in Action
    HHS Appeals Board Upholds FDA’s Interpretation of How to Count Violations in Tobacco Civil Money Penalty Enforcement Actions 
    On June 30, the Department of Health and Human Services’ Departmental Appeals Board (DAB) issued a final decision finding in favor of FDA’s Center for Tobacco Products (CTP) in a case brought by CTP against the tobacco retailer Orton Motor Co., d/b/a Orton’s Bagley. The DAB held that it was reasonable and permissible for CTP to count each time the retailer failed to comply with a tobacco regulation as a violation of the Federal Food, Drug, and Cosmetic Act. More information.
    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

    Lab tech and microscope
    FDA and Cosmetic Approval 
    Cosmetic products are regulated by FDA's Center for Food Safety and Applied Nutrition (CFSAN). CFSAN is responsible for assuring that cosmetics are safe and properly labeled. FDA does not approve cosmetics, although we do approve color additives used in cosmetics. It is the responsibility of cosmetic manufacturers to ensure, before marketing their products, that the products are safe when used as directed in their label or under customary conditions of use. More information.
    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 FDA Patient Network 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
    pregnant woman w repellent
    Zika Virus Response Updates from FDA 
    Zika virus is spread to people primarily through the bite of an infected Aedes species mosquito. Most people never know that they have been infected with the virus. It is estimated that four out of five people with Zika virus infections have no symptoms at all. When symptoms do occur, the most common symptoms are fever, rash, joint pain, and conjunctivitis (red eyes). Even in those who develop symptoms, the illness is usually mild, with symptoms lasting from several days to a week. More information.
    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 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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