News you can use: health & drug safety updates


  • April 26, 2006
    FDA notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old. Parents and caregivers should also be careful and get a doctor’s advice about giving promethazine HCl in any form to children age two and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.
  • April 25, 2006
    The Food and Drug Administration (FDA) lacks a clear and effective process for making decisions about and providing management oversight of post-marketing drug safety issues, the Government Accountability Office (GAO) said today. There is a lack of criteria for determining what safety actions to take and when to take them,” GAO stated. Squabbling between FDA’s Office of New Drugs (OND), the office that approves the marketing of medications, and the Office of Drug Safety (ODS), which oversees post-marketing safety reviews, has hindered the
  • March 13, 2006
    The U.S Food and Drug Administration (FDA) is advising healthcare professionals and consumers that filling U.S. prescriptions abroad may give patients the wrong active ingredient for treating their health condition. Some FDA-approved products have the same brand names as drug products that are marketed outside the U.S. but contain completely different active ingredients. In addition, 105 U.S. brand names are so similar to foreign brand names used for products with different active ingredients that patients who fill prescriptions abroad may inadvertently get
  • 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


  • 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