Letters Outline Adverse Events
A letter from Eli Lilly and Co. dated September 28, 2004, to European clinicians stated that a total of 49 adverse events, including eight fatal events, had been reported for Zyprexa IM as of August 31, 2004. Cardiorespiratory depression, hypotension, and bradycardia were among these reported cases.
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. | |||||
