March 24, 2015
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON -- A U.S. Food and Drug Administration (FDA) review of two deaths associated with Eli Lilly and Company ’s injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) were inconclusive.
Elevated levels of the medication were found in the two patients who died in 2013, between three and four days after they received the injection.
“We are unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection,”the FDA said in a press release.
The FDA said that much of the increase in drug levels could have occurred after death, explaining the extremely high blood levels of the drug found in the two patients days after their deaths.
Zyprexa Relprevv contains the antipsychotic drug olanzapine. The medication carries a boxed warning, the FDA‘s most serious type of warning, for post-injection delirium sedation or olanzapine overdose. The FDA said it would not recommend any changes to the current prescribing or use of Zyprexa Relprevv.
The FDA approved Zyprexa Relprevv for the treatment of schizophrenia in adults in 2009. Zyprexa Relprevv, a long-acting intramuscular injection, sustains the delivery of olanzapine for up to four weeks.
To reduce the risk of post-injection delirium sedation (PDSS), there is also a Risk Evaluation and Mitigation Strategy (REMS) for Zyprexa Relprevv to ensure that patients are observed by health care professionals at a certified facility following injection. The FDA said health care professionals should continue to follow the Zyprexa Relprevv Patient Care Program REMS requirements and current label recommendations.
The FDA study was undertaken following the deaths of the two patients who received appropriate doses of Zyprexa Relprevv. The FDA requested the drug’s manufacturer, Eli Lilly and Company, to conduct an animal study to test whether movement of olanzapine into blood after death could lead to higher-than-expected blood levels of the drug.
The study showed that some animals had increases in drug levels in the blood after death, which could account for the higher-than-expected blood levels found in the two patients who died.
Zyprexa’s 2014 sales have fallen to $1.04 billion from $4.62 billion in 2011, primarily due to competition from generic medications, Reuters reported.
The Mayo Clinic defines schizophrenia as a severe brain disorder in which people interpret reality abnormally. Schizophrenia may result in some combination of hallucinations, delusions, and extremely disordered thinking and behavior. The disorder requires lifelong treatment. Approximately 2.4 million Americans suffer from schizophrenia.
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