jueves, 1 de septiembre de 2016

OHCA Patient Newsletter: August 31, 2016


Expanded Recall: Ton Shen Health/Life  “DHZC-2 Tablet” to All Lots Purchased Before August 24 2016 Because of Possible Health Risk 
Ton Shen Health/Life Rising Corporation of Chicago, IL, is expanding its recall of “DHZC-2” Tablets to all lots purchased before August 24, 2016 because they have the potential to be contaminated with elevated levels of lead. The recalled "DHZC-2" tablets were sold nationwide in retails stores and distributed through mail orders. The product comes in a 1.6 ounce bottle, UPC: 616042102727. Lead is a toxic substance present in our environment in small amounts and everyone is exposed to some lead from daily actions such as inhaling dust, eating food, or drinking water. In general, the small exposure to lead within the U.S. population does not pose a significant public health concern. However, exposure to larger amounts of lead can cause lead poisoning. More information
Recall: Alere INRatio® and INRatio2® PT/INR Monitoring System Due to Incorrect Test Results 
Alere plans to remove the INRatio® and INRatio®2 PT/INR Monitoring System, which includes the INRatio® or INRatio2® PT/INR Monitor and the INRatio® Test Strips, from the market and discontinue manufacture of the product line. These handheld devices are used to monitor blood clotting time as measured by PT/INR values in people taking warfarin (also known by the brand name Coumadin®). The system is intended for both health care professional and home use. Under certain conditions, the device may generate an incorrect low result. If an incorrect low INR result is acted upon (i.e. adjusting the dose), the patient may be at risk of major or fatal bleeding. More information
Recall: Eyesaline Eyewash by Honeywell - Microbial Contamination 
Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury. Although no injuries have been reported and no contamination was found in batch testing, there is a risk of product contamination with Klebsiella pneumoniae. Although found in the normal flora of the mouth and skin, if the contaminant were present in a bottle, there is a potential for it to result in infections that may be sight-threatening. More information. 
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Recall: Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack 
Arbor Pharmaceuticals, LLC (Arbor) announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal  of the  blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the  blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack. Cetylev effervescent tablets for oral solution are indicated as an antidote for acetaminophen overdose after ingestion of amounts that are greater than the therapeutic concentration or maximum dose in a medical treatment. More information.
Recall: Lamotrigine Orally Disintegrating Tablet 200 mg by Impax 
Impax Laboratories, Inc. issued a voluntary nationwide retail level recall on August 19, 2016, for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg, NDC 0115-1529-08, Lot # 502240. Unit-of-use blister packs (a 10 count blister card contained in a single plastic shell-pack) may contain 100 mg product instead of 200 mg product. Each blister card within the unit-of-use blister pack is properly labeled as 100 mg ODT, however the plastic shell pack containing the 100 mg blister cards is labeled as 200 mg ODT. Shell-packs from the affected lot may contain 100 mg ODT instead of 200 mg ODT, and as a result, it is possible that consumers could take less than their intended lamotrigine dose. Lamotrigine is indicated for the treatment of epilepsy or bipolar disorders. More information
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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 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:
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 

      Medical Product Approvals
      FDA Approved
      FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injuryFDA has permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury. The devices are meant to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury. More information
      FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery
      FDA has approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery. 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 Basics Webinar: FDA's MedWatch Program: Voluntarily Reporting Problems to the FDA
        Date: September 8, 2016
        Time: 1:00 pm EDT
        Did you know that you can report problems that you have had with drugs and other medical products to the FDA? Did you know that MedWatch can send safety alerts directly to you, as soon as they appear on the web site? The featured speaker, Cristina Whalen Klafehn PharmD, BCPS, CDE, a Health Programs Coordinator in FDA’s Office of Health and Constituent Affairs will give an overview of the program, including recent updates, on the reporting of adverse events to the FDA. More information
        Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components As a further safety measure against the emerging Zika virus outbreak, FDA has issued a revised guidance recommending universal testing of donated whole blood and blood components for Zika virus in the U.S. and its territories. The revised guidance replaces earlier guidance issued in February and March of this year. More information.
        Food and kids
        Foods and Veterinary Medicine (FVM) Program’s Strategic Plan Fiscal Years 2016–2025 
        FDA released the Foods and Veterinary Medicine (FVM) Program’s Strategic Plan for fiscal years 2016-2025, which outlines goals and objectives for the next 10 years.The congressionally-mandated modernization of the FDA’s regulatory framework for preventing foodborne illness is one of the most challenging initiatives in FDA’s history and will have significant public health and economic benefits. We also have many opportunities to promote and facilitate healthy food choices for the population and enhance the health of animals. 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.
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          For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.

          What to Know When Buying or Using a Breast Pump
          If you’re giving your baby breast milk, you probably know there can be times when a breast pump can come in handy. Breast pumps are medical devices regulated by FDA. They can be used to maintain or increase a woman’s milk supply, relieve engorged breasts and plugged milk ducts, or pull out flat or inverted nipples so a nursing baby can latch on more easily. And there are important safety considerations if you use one. More information.
          Contact Lens Solutions With Hydrogen Peroxide: To Avoid Injury, Follow All Instructions 
          FDA regulates contact lenses and certain contact lens care products as medical devices. Before you choose a contact lens solution, talk to your eye-care provider about the best cleaning and disinfecting method for you. For instance, contact lens multipurpose solutions clean, disinfect, and condition contact lenses. Other lens cleaning products contain hydrogen peroxide, which requires special care for safe use. Incorrect care of contacts can increase your risk of eye infections and injury—and can cause blindness in rare cases. 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 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
          Center for Veterinary Medicine Kids Page
          Come explore the world of the Center for Veterinary Medicine!  Find out about how we protect you and your pets by making sure you and your pets have safe food and medicine. We have interesting and fun facts and activities for all ages.
          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

          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
          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
          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 
            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
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