By: Irvin Jackson | Published: June 19th, 2013
Federal drug regulators have launch a safety investigation into the potential side effects of Zyprexa Replrevv, a long-acting version of the popular antipsychotic medication, which has been linked to reports of at least two patient deaths several days after receiving the injection.
The FDA issued a Zyprexa Relprevv drug safety communication on June 18, warning that the two patient deaths were unexplained, but occurred three to four days after receiving injections of the drug. Both victims had very high levels of Zyprexa’s active ingredient, olanzapine, in their blood after death, the FDA warned.
Zyprexa Relprevv (olanzapine pamoate) is a long-acting injectable version of the atypical antipsychotic Zyprexa. The Eli Lilly drug is approved for the treatment of schizophrenia, but the FDA was so concerned about the safety of the drug when it was approved in 2009, that it is only available through a Risk Evaluation and Mitigation Strategy (REMS) that requires three hours of post-injection monitoring.
The REMS program for Zyprexa Relprevv requires that the injections be given at a REMS-certified health care facility, three hours of monitoring after the injection, and that the patient be accompanied home from the facility where they were injected. However, the monitoring ends after the three-hour period, after which it is generally assumed that the patient is safe from the risk of high levels of Zyprexa in the blood.
FDA investigators have yet to explain why the two patients who died still had high Zyprexa blood levels days later, and have not said whether it was the high Zyprexa blood levels that killed them.
High levels of Zyprexa in the blood can cause delirium, cardiopulmonary arrest, cardiac arrhythmias, and a can reduce consciousness; causing anything from sedation to coma. The FDA is continuing to evaluate the deaths and has promised to release more information once it becomes available.
The warning comes just a month after a study presented at the annual meeting of the Heart Rhythm Society that warned that all antipsychotics were linked to an increased risk of death due to cardiac arrest. Antipsychotics have also been linked to an increased risk of diabetes and weight gain, and may increase the risk of abnormal muscle movements and other problems in newborns when taken by pregnant women.
Antipsychotics are among the best selling drugs in the world, with about two-thirds of all prescriptions involving the newer, more expensive atypical antipsychotics, which generate nearly $15 billion in annual sales.