FDA Probes Deaths of Zyprexa Patients
June 19th, 2013 // 12:19 pm @ jmpickett
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FDA is now looking into the mysterious deaths of two people who had been injected with Zyprexa, which is an antipsychotic drug that is marketed by Eli Lilly. Each subject died within a few days of the injection. FDA noted that the deaths occurred several days after the three hour monitoring time that is required after injection, as required by the REMS safety program.
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FDA states that both of the patients had high levels of Zyprexa in the blood. Such a high dose of the drug can cause heart problems, arrhythmia and a lower lever of consciousness. Coma also can result. The label states warnings about a risk of PDSS, or post injection delirium sedation syndrome. This is a very serious problem where the drug goes into the blood too quickly after an injection in the muscle.
Zyprexa is FDA approved for an injection every 2-4 weeks to treat patients with schizophrenia. It is one of several choices for antipsychotic drugs, but PDSS has not been seen in the other drugs. FDA notes that there were some cases of PDSS in clinical trials that were seen within three hours of Zyprexa being injected, but no deaths occurred. It is not clear if the two patients died from the PDSS injection.
Eli Lilly has stated publicly that it does not have enough information to tell if the deaths are related to Zyprexa. Lilly does not know of any confirmed cases of the syndrome in clinical trials or in post marketing use. About 50,000 people have received Zyprexa injections to date.
