News you can use: health & drug safety updates


  • August 22, 2005
    The U.S. Food and Drug Administration (FDA) will conduct a series of public meetings in three cities entitled “Vision 2006-A Conversation with the American Public.” The purpose of the meetings is to update the public on its current programs and also to obtain consumer input on specific issues to help shape its agenda for 2006 and beyond. A notice in the August 16, 2005 Federal Register provides details, including questions for consumers to consider. Some of the discussion topics FDA is considering include seeking new opportunities to advance
  • August 16, 2005
    A new Agency for Healthcare Research and Quality-funded study shows that patients face a significant risk for preventable adverse events and serious medical errors in hospital critical care units. Researchers found that over 20 percent of the patients admitted to two intensive care units at an academic hospital, a medical intensive care unit and a coronary critical care unit experienced an adverse event. Because these patients are among the sickest, they may be more vulnerable to errors in care, and therefore more susceptible to injury. Of the adverse events in
  • August 12, 2005
    The U.S. Food and Drug Administration (FDA) has announced a strengthened distribution program for isotretinoin, called iPLEDGE, aimed at preventing use of the drug during pregnancy. Women who are pregnant or who might become pregnant should not take the drug. Isotretinoin (Accutane and its generics) is a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of birth defects if taken during pregnancy. The manufacturers are implementing a program that requires registration in iPLEDGE by doctors and patients who agree
  • August 11, 2005
    The Food and Drug Administration (FDA) has announced that the Perrigo Company has initiated a voluntary nationwide recall of all lots of concentrated infants' oral drops that are packaged with a dosing syringe bearing only a “1.6 mL” mark containing acetaminophen; acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl; or dextromethorphan HBr, and pseudoephedrine HCl . The dosing syringe may be confusing in determining the proper dose for infants under two (2) years of age as directed by a doctor and could lead to improper
  • July 14, 2005
    After acquiring new information that serious and potentially fatal adverse reactions can occur when Palladone (hydromorphone hydrochloride) extended release capsules are taken together with alcohol, the U.S. Food and Drug Administration has asked Purdue Pharma L.P., the makers of the drug, to withdraw it from the market. Palladone is a once-a-day pain management drug containing a very potent narcotic. New data gathered from a company-sponsored study testing the potential effects of alcohol use shows that when Palladone is taken with alcohol
  • 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