Federal regulators are investigating two "unexplained" deaths in people who received an injection of an Eli Lilly & Co. antipsychotic drug.
The Food and Drug Administration posted a drug-safety communication on its website Tuesday, saying the patients received an injection of Zyprexa Relprevv and died three to four days afterward. The agency said both patients were found to have "very high" blood levels of the drug in their systems after death. The agency also said both patients had received an appropriate dose of the product.
The Food and Drug Administration posted a drug-safety communication on its website Tuesday, saying the patients received an injection of Zyprexa Relprevv and died three to four days afterward. The agency said both patients were found to have "very high" blood levels of the drug in their systems after death. The agency also said both patients had received an appropriate dose of the product.
"Based on the information available to us, we are unable to conclude whether the two deaths were related to administration of Zyprexa Relprevv," Eli Lilly said. "However, we are continuing to evaluate this important safety issue and will communicate any clinically significant safety information that affects the product."
Neither the company nor the FDA would say when the patient deaths occurred, though an FDA spokeswoman said one death was in the U.S. and the other in Europe.
The drug is sold with the brand name Zypadhera outside the U.S. The product had less than $60 million worth of sales in 2012. The oral form of Zyprexa, which is also sold by other drug makers in generic versions, has a wider approval and is also used to treat bipolar disorder and depression that doesn't respond to other treatments.
An Eli Lilly spokesman said the FDA alert involved Zyprexa Relprevv, the long-acting injection, rather than the oral form of Zyprexa. About 50,000 patients world-wide have received the injections.
Zyprexa Relprevv was approved by the FDA in December 2009, after a delay, to treat schizophrenia. In 2008 the agency asked the company for more information about "excessive sedation" that was seen in some patients during clinical trials.
Patients receiving Zyprexa injections are required to be monitored for three hours after receiving the injection. The drug's label contains a warning about the risk of post-injection delirium sedation syndrome, a serious condition in which the drug enters the blood too fast.
The FDA said the condition was seen in clinical trials of Zyprexa Relprevv but no deaths were seen. The FDA said it isn't clear if the two patients died from post-injection delirium sedation syndrome.
Neither the company nor the FDA would say when the patient deaths occurred, though an FDA spokeswoman said one death was in the U.S. and the other in Europe.
The drug is sold with the brand name Zypadhera outside the U.S. The product had less than $60 million worth of sales in 2012. The oral form of Zyprexa, which is also sold by other drug makers in generic versions, has a wider approval and is also used to treat bipolar disorder and depression that doesn't respond to other treatments.
An Eli Lilly spokesman said the FDA alert involved Zyprexa Relprevv, the long-acting injection, rather than the oral form of Zyprexa. About 50,000 patients world-wide have received the injections.
Zyprexa Relprevv was approved by the FDA in December 2009, after a delay, to treat schizophrenia. In 2008 the agency asked the company for more information about "excessive sedation" that was seen in some patients during clinical trials.
Patients receiving Zyprexa injections are required to be monitored for three hours after receiving the injection. The drug's label contains a warning about the risk of post-injection delirium sedation syndrome, a serious condition in which the drug enters the blood too fast.
The FDA said the condition was seen in clinical trials of Zyprexa Relprevv but no deaths were seen. The FDA said it isn't clear if the two patients died from post-injection delirium sedation syndrome.
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