FDA probes 'unexplained' deaths from schizophrenia drug Zyprexa

Two "unexplained" deaths caused by injections of Zyprexa, an anti-psychotic medication used to treat schizophrenia, are being investigated by the Food and Drug Administration.

According to the FDA, two people died within just a few days of getting the drug injections, and the patients had very high levels of the substance in their bloodstreams.

Potential risks

Zyprexa comes with a warning insert, detailing how the drug can cause post-injection delirium sedation syndrome (PDSS), a condition that is caused by the drug entering the bloodstream too fast. And a bulletin on the FDA's website states that Zyprexa can cause cardiopulmonary arrest, heart rhythm problems or coma.

Sandy Walsh, an FDA spokesperson, said that cases of PDSS were reported in clinical trials, but none of them caused deaths. Officials from Eli Lilly, producers of the drug, explained in an email:

Based on the information available to us, we are unable to conclude whether the two deaths were related to administration of [Zyprexa]. However, we are continuing to evaluate this important safety issue and will communicate any clinically significant safety information that affects the product. To date, Lilly is not aware of any confirmed cases of post-injection delirium/sedation syndrome associated with a fatal outcome reported in either clinical trials or in post-marketing use.

The email also notes that the deaths are were strictly related to Zyprexa, and that other anti-psychotic medications aren't part of the FDA investigation.

Zyprexa is sold in several forms, including an oral medication. The injections are accompanied by warnings that patients must remain at a doctor's office for at least three hours after the medicine is taken so they can be monitored for potential complications.

Source: Reuters, MarketWatch

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