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Letters Outline Adverse Events

The letter stated, "A review of the reported fatalities indicates use of Zyprexa IM in a manner that is inconsistent with the Summary of Product Characteristics including excessive dosing and/or inappropriate use of concomitant benzodiazepines and/or other antipsychotics."

The letter outlines the following recommendations about use of Zyprexa IM:

• The maximum combined intramuscular and oral daily dose of Zyprexa is 20 mg, with an initial dose of Zyprexa IM 10 mg as a single injection (use lower doses in elderly patients and those with renal or hepatic impairment).
  
• A maximum of three injections of Zyprexa IM may be administered in 24 hours. A minimum of two hours should elapse between the first and second injections.
  
• Zyprexa IM is intended for short-term use only, for up to a maximum of three consecutive days.
  
• Zyprexa IM should not be administered to patients with unstable medical conditions.
  
• Patients treated with Zyprexa IM should have heart and respiratory rates, blood pressure, and level of consciousness carefully observed for two to four hours following administration.
  
• Simultaneous injection of Zyprexa IM and parenteral benzodiazepines is not recommended.
  

A similar letter to Canadian clinicians dated September 7, 2004, outlined the following examples of inappropriate use of Zyprexa IM that were reported to Lilly:

• In one patient, Zyprexa IM was administered in a total daily dose of 30 mg, which is greater than the maximum recommended by the product monograph, along with other medications including intramuscular lorazepam, intramuscular promethazine, chlorpromazine, and promazine.
  
• In another patient who committed suicide, Zyprexa IM was administered in a total daily dose of 30 mg, greater than the maximum recommended by the product monograph, followed by Zyprexa tablets in a cumulative dose greater than the maximum recommended by the product monograph.
  
• An 82-year-old patient was treated with Zyprexa IM, as well as intramuscular haloperidol and intramuscular lorazepam. This patient also had dementia, for which Zyprexa is not indicated in Canada.
  

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