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Higher than Physician's Desk Reference (US) doses on atypical antipsychotics.

Paul J Goodnick1

  • 1Department of Psychiatry & Behavioural Sciences, Carrier Clinic, UMDNJ Robert Wood Johnson School of Medicine, 252 CR 601, Belle Mead, NJ 08502, USA. pgoodnick@aol.com

Expert Opinion on Drug Safety
|July 14, 2005
PubMed
Summary

Many patients require higher atypical antipsychotic doses than FDA-approved levels for optimal therapeutic response. Research indicates higher doses are often safe and effective, contrary to initial FDA approvals.

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Area of Science:

  • Pharmacology
  • Psychiatry

Background:

  • The Physician's Desk Reference (PDR) lists FDA-approved drug labeling and dosages.
  • Pharmaceutical companies often seek lowest effective doses for FDA approval to maximize individual usage.
  • Many patients with complex conditions may need higher doses than initially approved for maximum therapeutic benefit.

Purpose of the Study:

  • To evaluate the efficacy and safety of higher-than-approved atypical antipsychotic doses.
  • To compare FDA-approved dosages with doses found effective in clinical data.

Main Methods:

  • Review of FDA-approved labeling for atypical antipsychotics.
  • Analysis of data from double-blind trials, open-label trials, reviews, and case reports.
  • Examination of safety and efficacy data for doses exceeding current FDA recommendations.

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Main Results:

  • Risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole have FDA-approved doses that may limit benefits.
  • Clinical data suggest higher maximum doses are safe and/or effective: olanzapine (40 mg), quetiapine (1600 mg), ziprasidone (320 mg), aripiprazole (75 mg).
  • Increased adverse events were not consistently observed at higher doses in many cases.

Conclusions:

  • Current FDA-approved doses for atypical antipsychotics may be suboptimal for some patients.
  • Higher doses, supported by clinical evidence, can potentially enhance therapeutic outcomes without significantly increasing risks.
  • Further investigation into optimal dosing strategies for atypical antipsychotics is warranted.