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    Comparative safety evaluation of non-narcotic analgesics

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    Authors
    Andrade, Susan E.
    Martinez, Carlos
    Walker, Alexander M.
    UMass Chan Affiliations
    Meyers Primary Care Institute
    Document Type
    Journal Article
    Publication Date
    1998-12-23
    Keywords
    Acetaminophen
    Anti-Inflammatory Agents, Non-Steroidal
    Aspirin
    Diclofenac
    Dipyrone
    Drug Evaluation
    Drug and Narcotic Control
    Epidemiologic Methods
    Humans
    Incidence
    Middle Aged
    *Mortality
    Risk
    Health Services Research
    Primary Care
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    Link to Full Text
    http://dx.doi.org/10.1016/S0895-4356(98)00076-6
    Abstract
    Both spontaneous reports and single outcome studies may distort the overall safety evaluation of drugs. We identified epidemiologic studies, published from January 1970 to December 1995, that investigated the association of serious adverse effects with aspirin, diclofenac, acetaminophen, and dipyrone to determine and compare the excess mortality associated with short-term drug use. The estimated excess mortality due to community-acquired agranulocytosis, aplastic anemia, anaphylaxis, and serious upper gastrointestinal complications was 185 per 100 million for aspirin, 592 per 100 million for diclofenac, 20 per 100 million for acetaminophen, and 25 per 100 million for dipyrone. The estimates were largely influenced by the excess mortality associated with upper gastrointestinal complications. A relative risk estimate of 300 or more for the association of dipyrone with agranulocytosis would have been necessary for the excess mortality of dipyrone to be comparable to that of aspirin or diclofenac. Based on published epidemiologic evidence used to determine the excess mortality associated with short-term use of these four non-narcotic analgesics, the current regulatory ranking of the drugs appears inappropriate.
    Source
    J Clin Epidemiol. 1998 Dec;51(12):1357-65.
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/36867
    PubMed ID
    10086830
    Related Resources
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    UMass Chan Faculty and Researcher Publications

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