News you can use: health & drug safety updates

2005

  • April 8, 2005
    The Food and Drug Administration (FDA) has asked Pfizer to voluntarily remove Bextra (valdecoxib) from the market. FDA is also asking manufacturers of all marketed prescription Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including Celebrex (celecoxib), a COX-2 selective NSAID, to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use.
  • April 8, 2005
    As Congress considers a law to classify cough and cold medications as Schedule V drugs, making them available only through a doctor’s prescription in 17 states, a survey commissioned by the Food Marketing Institute and the National Consumers League has found that consumers are in agreement with some restrictions on products that can be used to make illegal methamphetamine, but are concerned about access for legitimate users.
  • March 3, 2005
    The Alliance for Aging Research has conducted the Women’s Bone Health Survey, asking 752 postmenopausal women (PMW) diagnosed with osteoporosis and 352 physicians to offer an in-depth look at their respective attitudes and beliefs about protecting bone health. The survey revealed that doctors and patients may not be speaking the same language, nor speaking often enough, about osteoporosis. More than half of doctors (56 percent) do not speak with their osteoporosis patients about the condition at each visit, and two-thirds of patients surveyed (62
  • March 1, 2005
    The National Association of Boards of Pharmacy (NABP) announced that it is now accepting applications for accreditation through the Verified-Accredited Wholesale Distributors (VAWD) program. VAWD accredits wholesale distributors of prescription drugs and devices and serves as a vehicle to help protect the public from the threat of counterfeit drugs affecting the United States' drug supply. VAWD accreditation assures stakeholders that wholesaler distributors are legitimate, qualified for state licensure, and employing security and best practices
  • February 22, 2005
    HHS Secretary Mike Leavitt and Acting FDA Commissioner Lester M. Crawford unveiled a new vision for FDA that will promote a culture of openness and enhanced oversight within the Agency. As part of this vision, FDA will create a new independent Drug Safety Oversight Board to oversee the management of drug safety issues, and will provide emerging information to health providers and patients about the risks and benefits of medicines. The DSB will comprise members from the FDA and medical experts from other HHS agencies and government
  • February 14, 2005
    FDA is aware of Health Canada’s decision to suspend sales, but not revoke the approval in Canada, of the drug Adderall as a treatment for Attention Deficit and Hyperactivity Disorder (ADHD). FDA has been in close consultation with the Canadian authorities regarding the FDA basis for their action. FDA does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada’s analyses of adverse even reports and FDA’s own knowledge and assessment of the reports
  • February 7, 2005
    The Journal of Women’s Health has published a special issue on improving the use and safety of medications in women, which was edited by Rosaly Correa-de- Araujo, M.D., M.Sc., Ph.D., AHRQ’s Senior Advisor for Women’s Health. The articles in this issue were based on discussions at an expert meeting called by Dr. Correa- de-Araujo to highlight gender differences in medication use. Topics of the articles include evidence for gender and racial differences in drug response, the role of biological rhythms in medication safety for women, geriatric pharmacotherapy, and
  • January 31, 2005
    A new Agency for Health Care Research and Quality (AHRQ) study found that elderly patients were prescribed at least one medication that could have caused a harmful drug-disease interaction in more than 2.5 percent of outpatient visits. The likelihood that a patient was prescribed a medication that had the potential for a harmful drug-drug interaction was slightly less than 1 percent in visits that involved two or more prescriptions. Using data from 1995 to 2000, researchers assessed the likelihood that a patient would receive a prescription for a medication
  • January 24, 2005
    A revised, plain language version of the 2000 consumer brochure by the same name. NCPIE is pleased to have collaborated with FDA to produce this product.
  • January 10, 2005
    As people across the United States face the coldest months of the year when many respiratory infections become more common, the Centers for Disease Control and Prevention (CDC) is reminding people to be cautious about their use of antibiotics. As part of this reminder, CDC is releasing a new series of print and radio public service announcements (PSAs) to raise awareness about proper antibiotic use among parents and healthy adults. The message is part of Get Smart: Know When Antibiotics Work - a national campaign started one year

Pages