News you can use: health & drug safety updates


  • July 5, 2005
    The Food and Drug Administration (FDA) approved BiDil (bye-DILL), a drug for the treatment of heart failure in self-identified black patients, representing a step toward the promise of personalized medicine. The approval of BiDil was based in part on the results of the African-American Heart Failure Trial (A-HeFT). The study, which involved 1,050 self-identified black patients with severe heart failure who had already been treated with the best available therapy, was conducted because two previous trials in the general population of severe heart failure
  • May 27, 2005
    The Food and Drug Administration (FDA) has taken action to ensure that the public is fully aware that Able Laboratories of Cranbury, NJ, is conducting a nationwide recall of all of its manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) because of serious concerns that they were not produced according to quality assurance standards. The FDA recommends that people who have been taking drugs produced by this firm speak with their health care provider or pharmacist to obtain a replacement drug
  • May 18, 2005
    Admissions for substance abuse treatment increased by 32 percent among older adults over the eight-year period 1995-2002, concludes a new study released today by the Substance Abuse and Mental Health Services Administration (SAMHSA). The report, “Older Adults in Substance Abuse Treatment: Update,” found that the percent of older adults with opiates as their primary substance of abuse increased from 6.8 percent to 12 percent in this time period. Opiates include prescription pain medications and heroin. Opiates are the second most frequent reason for
  • May 12, 2005
    The Food and Drug Administration (FDA) is warning the public about the sale of counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as “generic Evista” to U.S. consumers at pharmacies in Mexican border towns. Consumers who have any of these counterfeit products should not use them and should contact their healthcare provider immediately. FDA is warning consumers that prescription drugs purchased in foreign countries are not regulated by the FDA and do not carry the same FDA assurances of safety, effectiveness, and
  • May 9, 2005
    The U.S. Food and Drug Administration (FDA) launched a new program to make drug safety information available in an easily accessible format to make safety information available about the medicines consumers are using. Included in the announcement: drug safety information in a new web location; Draft Guidance: FDA’s “Drug Watch” for Emerging Drug Safety Information; Manual of Policies and Procedures: Drug Safety Oversight Board; Questions and Answers on FDA’s New Drug Safety Initiative; and questions and answers on the Initiative. (Note: There
  • 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.