News you can use: health & drug safety updates

2006

  • January 30, 2006
    There is a new, potential alternative for many of the more than 5 million Americans who take insulin injections, with the Food and Drug Administration’s approval today of the first ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s. Diabetes is a disease that affects the amount of insulin and sugar in your body.
  • January 18, 2006
    The Food and Drug Administration (FDA) unveiled a major revision to the format of prescription drug information, commonly called the package insert (PI), to give healthcare professionals clear and concise prescribing information. In an effort to manage the risks of medication use and reduce medical errors, the newly designed PI will provide the most up-to-date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. The new format will also make

2005

  • December 21, 2005
    As a result of research efforts led by Barry D. Weiss, MD, University of Arizona College of Medicine, health-care providers soon will have access to a new tool designed to assess a patient’s health literacy skills quickly and simply. Knowing if a patient can understand and act on health information enables the healthcare provider to tailor their communication and enhance patient understanding. Dr. Weiss and his team of researchers, working in collaboration with colleagues at the Univ. of North Carolina, have developed the Newest Vital Sign (NVS),
  • December 20, 2005
    The FDA announced that Trileptal, a drug to treat seizures, has become the 100th medicine to have new information for children and teenagers included in its labeling. Under eight years of legislation to enhance pediatric drug information, 100 pediatric drugs now include additional labeling information on safety, efficacy, dosing and unique risks for children. The Federal Food, Drug, and Cosmetic Act (as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the 2002 Best Pharmaceuticals for Children Act (BPCA), provides incentives to companies who
  • December 20, 2005
    The Agency for Healthcare Research and Quality (AHRQ), a non-voting member of the National Council on Patient Information and Education (NCPIE) board of directors, has released a five-minute Web video called “Tips for Taking Medicines Safely,” which features information to help consumers take their medicines safely and appropriately. Tips covered in the video include asking questions if you have doubts or concerns about your medicine; bringing a bag with all the medicines you take to your medical appointments; and asking about side
  • December 19, 2005
    An FDA operation found that nearly half of the imported drugs it intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with “Canadian” pharmacies. Of the drugs being promoted as “Canadian,” based on accompanying documentation, 85 percent actually came from 27 countries around the globe. A number of these products also were found to be counterfeit. “This operation suggests that drugs ordered from so- called 'Canadian' Internet sites are not drugs of known safety and efficacy,” said
  • November 14, 2005
    An AHRQ-funded study found that more than 50 percent of children who see the doctor for a sore throat are prescribed antibiotics; however, not all of these children needed an antibiotic. Only sore throats caused by Group A beta-hemolytic strep can be treated effectively with an antibiotic. But the research found that although the simple test for strep bacteria is performed on only 15 to 36 percent of children who have sore throats, 53 percent of them are prescribed antibiotics. Dr. Jeffrey Linder, principal investigator for the study at Brigham and Women’s
  • November 2, 2005
    The Food and Drug Administration (FDA) today began requiring drug manufacturers to submit prescription drug label information to FDA in a new electronic format. This electronic format will allow healthcare providers and the general public to more easily access the product information found in the FDA-approved package inserts ("labels") for all approved medicines in the United States. These new electronic product labels will be the key element and primary source of medication information for “DailyMed” — a new interagency online health information
  • October 27, 2005
    The U.S. Food and Drug Administration (FDA) is notifying health care providers and patients of a problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or
  • October 18, 2005
    Medicare partners will have additional resources available to help them inform and educate people about the new prescription drug coverage, including a new Prescription Drug Plan Finder, well before enrollment begins on November 15. Soon, beneficiaries and their family members will be able to use these tools to make better decisions about their Medicare drug coverage. The Prescription Drug Plan Finder, available at www.medicare.gov, is a new resource CMS is now using to help train local partners, such as the State Health Insurance

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