HealthDay News –The FDA is conducting an investigation into the possible causes of the death of two patients three to four days after they received a dose of olanzapine pamoate (Zyprexa Relprevv) via intramuscular injection.
The patients were well outside the three-hour window of monitoring required by the antipsychotic drug’s Risk Evaluation and Mitigation Strategy (REMS), but were found to have very high blood levels of olanzapine after death.
Zyprexa Relprevv, manufactured by Eli Lilly, is the more potent version of the original Zyprexa drug, which is the pharmaceutical company’s all-time best selling product. The drug was approved by the FDA in December of 2009 for the treatment of schizophrenia.
“Based on the information available to us, we are unable to conclude whether the two deaths were related to administration of Zyprexa Relprevv,” said Eli Lilly spokesperson Morry Smulevitz in a statement, explaining that the company is “continuing to evaluate this important safety issue and will communicate any clinically significant safety information that affects the product.”
In addition to the three-hour monitoring period, REMS protocol for the drug requires patients to receive injections only at REMS-certified facilities and to be accompanied home after the monitoring period. The drug’s label warns against possible post-injection delirium sedation syndrome (PDSS), in which the agent enters the blood too quickly and can cause delirium and altered levels of consciousness ranging from sedation to coma.
During clinical trials of the drug, researchers did observe cases of PDSS within three hours of injection, but none that proved fatal.
“We believe the science behind Zyprexa Relprevv has been well-established, and Lilly remains confident in its favorable benefit-risk profile,” Smulevitz said.
“Nearly 50,000 patients worldwide have received olanzapine pamoate in company-sponsored clinical trials and since product approvals,” he continued, adding that “patient health and safety are the top priorities at Lilly.”
The FDA noted that both patients received the appropriate dosage of the product.
The agency also clarified that health care professionals could continue to administer the drug, while reminding them to “follow the REMS requirements and drug label recommendations.” Meanwhile, “patients and caregivers should talk to their health care professional(s) about any questions or concerns.”
- FDA Drug Safety Communication: FDA is investigating two deaths following injection of long-acting antipsychotic Zyprexa Relprevv (olanzapine pamoate). June 18, 2013. Available at http://www.fda.gov/Drugs/DrugSafety/ucm356971.htm . Accessed June 20, 2013.