Quoted from http://www.reuters.com/article/2013/06/18/us-elililly-fda-idUSBRE95H0NP20130618
FDA probes deaths of two patients on Lilly schizophrenia drug
(Reuters) - The U.S. Food and Drug Administration on Tuesday said it was investigating the deaths of two patients who died following injections with Eli Lilly and Co's long-acting treatment for schizophrenia, called Zyprexa Relprevv.
The agency said the patients died three to four days after receiving an appropriate dose of the medicine, and had very high levels of the injectable drug in their bloodstreams.
The medicine's package insert label carries a prominent "black box" warning of post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an injection, causing greatly elevated levels of the drug in the bloodstream.