News you can use: health & drug safety updates

2005

  • May 2, 2005
    The Food and Drug Administration (FDA) and the United States Attorney for the District of Utah are announced a series of indictments against multiple prescription drug distributors whose illegal distribution of diverted drugs could affect the safety and efficacy of more than 40 medications purchased by consumers in over 80 pharmacies nationwide. Diverted drugs are medications illegally bought, sold or otherwise circulated outside established distribution systems that assure their quality. Individual pharmacies may be unaware that the product they are buying
  • April 19, 2005
    Four in 10 seniors told researchers that they haven't taken all the drugs their doctors prescribed for them in the past year - either because the costs were too high, because they didn't think the drugs were helping them, or because they didn't think they needed them. The survey reveals that many seniors deal with complex and costly drug regimens. Of the 89% of seniors who report taking prescription drugs in the past year, nearly half (46%) take five or more, more than half (54%) have more than one doctor who prescribes medicine, and about a third
  • April 15, 2005
    According to a new national survey, one in three (33%) U.S. adults who have been prescribed medicines to take on a regular basis report that they are often or very often noncompliant with their treatment regimens for any number of reasons. Furthermore, nearly half (45%) say they have failed to take their medications because of concerns they had about the drugs themselves, and 43 percent report having not complied with their regimens because they felt the drug was unnecessary. These are some of the results of a Harris Interactive online
  • April 12, 2005
    The Food and Drug Administration has issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved (i.e., “off-label") use of certain drugs called “atypical antipsychotic drugs.” These drugs are approved for the treatment of schizophrenia and mania, but clinical studies of these drugs to treat behavioral disorders in elderly patients with dementia have shown a higher death rate associated with their use compared to patients receiving a placebo (sugar pill). Today’s advisory
  • 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.
  • 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.
  • 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

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