Reuters: Regulatory News: UPDATE 1-FDA probes deaths of two patients on Lilly schizophrenia drug

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UPDATE 1-FDA probes deaths of two patients on Lilly schizophrenia drug Jun 18th 2013, 14:53 Tue Jun 18, 2013 10:53am EDT June 18 (Reuters) - The U.S. Food and Drug Administration on Tuesday said it was investigating the deaths of two patients who died following injections with Eli Lilly and Co's long-acting treatment for schizophrenia, called Zyprexa Relprevv. The agency said the patients died three to four days after receiving an appropriate dose of the medicine, and had very high levels of the injectable drug in their bloodstreams. The medicine's package insert label carries a prominent "black box" warning of post-injection delirium sedation syndrome (PDSS), a serious condition in which the drug enters the blood too fast following an injection, causing greatly elevated levels of the drug in the bloodstream. The FDA, in a bulletin on its website, said high doses of the drug can cause delirium, cardiopulmonary arrest, heart rhythm problems, sedation and coma. The medicine, approved by the FDA in late 2009, comes with warnings that patients must stay at the doctor's office for at least three hours after it is given so they can be monitored.

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