According to the FDA, the patients received the appropriate dose and were monitored as required for three hours after the injection before being allowed to go home. However, both patients died 3-4 days after receiving the injections, so the FDA cannot be sure whether Zyprexa Relprevv was related to the deaths.
Possible complications from these injections include post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an intramuscular injection, causing greatly elevated blood levels with marked sedation (possibly including coma) and/or delirium. During clinical trials, this condition occurred in some patients within 3 hours after injection - hence the mandatory 3-hour waiting and monitoring period. In trials, there were no reports of problems occurring after 3 hours. There were no deaths during the trials.
Both patients who died had high levels of olanzapine in their systems, but this by itself is not sufficient evidence to determine cause and effect. The FDA is not recommending discontinued use of the drug at this time.
I need to stress that the pill forms of Zyprexa are not being investigated. The FDA statement applies only to the Zyprexa Relprevv injection form.
- In depth information on this drug: Zyprexa Medication Profile