Tuesday, June 18, 2013

Zyprexa deaths in clinical trials and after the drug on the market

I wonder how many deaths Eli-Lilly has had in it's facilities during clinical trials.
These are the deaths reported at the Zyprexa leaflet under "side effects":

"Collective data gathered from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including olanzapine, for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug treated patient than in the placebo treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Similar results (i.e., increased risk of mortality with atypical antipsychotics) were reported in another meta-analysis involving elderly dementia patients that consisted of 15 randomized, placebo-controlled trials (n=3353) of 10 to 12 weeks in duration. Olanzapine is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia.

Cerebrovascular adverse events (e.g., stroke, transient ischemic attack) which included fatalities have been reported in trials of olanzapine on elderly patients with dementia-related psychosis. There was a significantly higher incidence of cerebrovascular adverse events in patients treated with olanzapine when compared to patients treated with placebo. However, the association between the use of atypical antipsychotics (i.e., risperidone, olanzapine) and the risk of cerebrovascular events appears to be somewhat controversial. The results of a case-control study found no increased risk of cerebrovascular events in elderly patients treated with atypical antipsychotics."

After approving the drug FDA is investigating two deaths:

FDA Probes Deaths Linked to Long-Acting Zyprexa
By John Gever, Deputy Managing Editor, MedPage Today
Published: June 18, 2013

SILVER SPRING, Md. -- Two patients died 3-4 days after injections with the long-acting antipsychotic drug olanzapine pamoate (Zyprexa Relprevv), prompting an FDA investigation.

The agency has not determined whether the drug caused the fatalities. "At this time, FDA is continuing to evaluate these deaths and will provide an update when more information is available," it said in a statement Tuesday.

Both patients received intramuscular injections of the drug at appropriate doses, the FDA said, but tests showed "very high olanzapine blood levels after death."

High doses are known to induce delirium, cardiopulmonary arrest, cardiac arrhythmias, and impaired consciousness ranging from sedation to coma.

The long-acting form of olanzapine was approved with a risk evaluation and mitigation strategy that requires patients to remain in the clinic for a 3-hour monitoring period and to be escorted home afterward. The requirement was imposed after some patients in clinical trials became delirious or lost consciousness shortly after receiving injections.

These events, dubbed post-injection delirium-sedation syndrome (PDSS), were traced to an unexpectedly rapid release of olanzapine into circulation leading to very high blood levels of the drug.

However, all those cases occurred within hours of injection, not days, and no deaths were attributed to the syndrome, the FDA said.

Olanzapine pamoate is approved for injection every 2-4 weeks for treating patients with schizophrenia. It is one of several long-acting formulations of "atypical" antipsychotic drugs currently available. PDSS has not been seen with those other products.

From: MepageToday.