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FDA Probes Eli Lilly's Zyprexa Following Two Deaths

Jun 19, 2013

The injectable version of Zyprexa, an antipsychotic drug manufactured by Eli Lilly, is being investigated by the U.S. Food and Drug Administration (FDA) after two patients died three to four days after receiving the injection, MedPage Today reports.

In a statement issued today, the agency said: "At this time, the FDA is continuing to evaluate these deaths and will provide an update when more information is available." According to the FDA, the patients received correct dosages, and so far, there is no evidence to suggest that the deaths were caused by overdose. Tests for both patients showed “very high olanzapine blood levels after death,” the agency said. High levels of Zyprexa can cause delirium, cardiopulmonary arrest, cardiac arrhythmias and impaired consciousness, from sedation to a coma.

Zyprexa is a medication manufactured by Eli Lilly used to treat schizophrenia, bipolar disorder, aggression, depression, psychosis and manic episodes. The long-acting form of Zyprexa was approved under the condition that patients would remain in the clinic for three hours after the injection so they can be monitored for signs of complications. The patients are also supposed to be escorted home. This risk evaluation and mitigation strategy was put in place after some patients became delirious and lost consciousness after receiving injections during clinical trials.

These side effects are known as post-injection delirium sedation syndrome (PDSS). PDSS is thought to be caused by an unexpectedly rapid release of the drug in the blood circulation. .

Zyprexa injections are given every two to four weeks when treating patients with schizophrenia. It is one of several long-acting "atypical" antipsychotic drugs currently on the market. PDSS has not yet been seen with other similar products.

Zyprexa generated $1.7 billion in revenue for Eli Lilly last year, according to Bloomberg. Sales peaked in 2010 at $5.03 billion.

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