Here is a mystery that will be closely tracked. The FDA is probing the unexplained deaths of two people who were injected with long-acting Zyprexa, the antipsychotic, which is sold by Eli Lilly. Each died three to four days after receiving the drug, which the agency notes is "well after" the three-hour monitoring period following injection that is required with the REMS, or risk evaluation and mitigation strategy, safety program.
According to the FDA, both patients had "very high" levels of the injectable drug in their bloodstreams. The FDA notes that high doses of Zyprexa can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and reduced level of consciousness ranging from sedation to coma. The label also points out warnings about the risk of post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an intramuscular injection (here is the FDA statement and here is the label).
The long-acting version of Zyprexa is approved for injection every two to four weeks for treating people with schizophrenia., and is one of several long-acting formulations of atypical antipsychotics, although PDSS was not observed in the other meds. The FDA adds that, in clinical trials, there were cases of PDSS seen within three hours after long-acting Zyprexa was administered, but there were no deaths due to PDSS. It remains unclear if these two patients died from PDSS.
A spokesman for Lilly (LLY) sends us this: "Based on the information available to us, we are unable to conclude whether the two deaths were related to administration of Zyprexa Relprevv. However, we are continuing to evaluate this important safety issue and will communicate any clinically significant safety information that affects the product. To date, Lilly is not aware of any confirmed cases of PDSS associated with a fatal outcome reported in either clinical trials or in post-marketing use." So far, nearly 50,000 people worldwide have received Zyprexa injections in trials and for treatment.
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