The U.S. Food and Drug Administration is investigating the cases of two individuals who died after injections with Eli Lilly and Co’s long-acting treatment for schizophrenia, Zyprexa Relprevv.
Both patients died three to four days after receiving “an appropriate dose” of the medicine, and both had very high levels of the drug in their bloodstreams, the FDA said in a bulletin released on its website on Tuesday.
The medicine’s package insert carries a prominent “black box” warning of risk from post-injection delirium sedation syndrome, or 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. High doses of the drug can cause delirium, cardiopulmonary arrest, heart rhythm problems, sedation and coma, the FDA said.
Lilly said it was not clear whether the two deaths were related to use of the drug.
“We are continuing to evaluate this important safety issue and will communicate any clinically significant safety information that affects the product,” Lilly spokesman Morry Smulevitz said in an emailed statement.
In Lilly’s clinical trials of Zyprexa Relprevv, cases of PDSS were seen within three hours of taking the drug, but no deaths from the syndrome were seen, the FDA said.
Zyprexa Relprevv, approved by the FDA in 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.
The drug is a long-acting version of Lilly’s widely used oral Zyprexa treatment, which was the company’s biggest product until it began facing competition from cheaper generics in 2011.
Zyprexa Relprevv competes with other long-acting treatments such as Johnson & Johnson’s Invega Sustenna. It is meant to offer weeks of symptom control for schizophrenia patients, who often fail to take their medication regularly.
The Lilly spokesman said Zyprexa Relprevv’s global sales were “less than $60 million” in 2012. Lilly has annual sales of more than $20 billion.
Global sales of Lilly’s Zyprexa franchise plunged 49 percent to $284 million in the first quarter of 2013 as cheaper generics continued to gain market share.
Lilly shares were down 6 cents to $52.30 in early-afternoon trading on the New York Stock Exchange.