Food and Drug Administration Letter Requesting Updated Product Labeling for All Atypical Antipsychot - PowerPoint PPT Presentation

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Food and Drug Administration Letter Requesting Updated Product Labeling for All Atypical Antipsychot

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Antipsychotics (9/15/03) '...Hyperglycemia, in some cases extreme and associated with ketoacidosis or ... Increased attention to the signs and symptoms of ... – PowerPoint PPT presentation

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Title: Food and Drug Administration Letter Requesting Updated Product Labeling for All Atypical Antipsychot


1
Food and Drug Administration Letter Requesting
Updated Product Labeling for All
AtypicalAntipsychotics (9/15/03)
  • ...Hyperglycemia, in some cases extreme and
    associated with ketoacidosis or hyperosmolar coma
    or death, has been reported in patients treated
    with atypical antipsychotics.
  • ...Increased attention to the signs and symptoms
    of diabetes mellitus may lead to earlier
    detection and appropriate treatment, and thus may
    reduce the risk for the most serious outcomes.
  • Some differences in wording have been agreed to
    by the FDA and individual pharmaceutical
    manufacturers of atypical antipsychotics

Rosack J. Psychiatric News. 2003381-4.
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