Both deceased patients were found to have "very high olanzapine blood levels after death," the FDA said. But since their deaths occurred days, not hours, after their injections of Zyprexa Relprevv, their connection to the so-called "depot medication" is uncertain. Clinical trials leading to the approval of the long-acting treatment for schizophrenia saw no deaths in subjects, and found instances of PDSS only in the first several hours following injection.
Under the Risk Evaluation and Mitigation Strategy (REMS) approved for Zyprexa Relprevv in December 2009, the injections and the three-hour post-injection period of monitoring must take place in a facility certified by the FDA to provide the shots. A long-acting injection can be a particular benefit in treating those with schizophrenia, who frequently fail to take oral medications on the prescribed schedule.