Eli Lilly and Co.’s injectable form of the antipsychotic Zyprexa is being investigated by U.S. regulators after two patients died three to four days after receiving the drug.
The two patients, given intramuscular injections of Zyprexa Relprevv, were later found to have very high levels of the drug in their systems, which can cause delirium, cardiac arrest, arrhythmias and coma, or loss of consciousness, the Food and Drug Administration said in a statement Tuesday. The agency isn’t calling the deaths an overdose, and said the patients hadn’t been given an inappropriate amount of the drug.
“Based on the information available to us, we are unable to conclude whether the two deaths were related to administration of Zyprexa Relprevv,” Morry Smulevitz, a spokesman for Indianapolis-based Lilly, said in an e-mail. “However, we are continuing to evaluate this important safety issue and will communicate any clinically significant safety information that affects the product.”
Zyprexa is used for the treatment of aggression, depression, manic episodes, schizophrenia and bipolar disorders. The pill form of the drug lost patent protection in 2011, while the injectable version has no generic competition.
Zyprexa generated $1.7 billion in revenue for Lilly last year, and sales peaked in 2010 at $5.03 billion, according to data compiled by Bloomberg. Zyprexa Relprevv sold less than $60 million in 2012, according to Smulevitz.
The FDA investigation relates only to the injectable version.
Patients who get the injections are supposed to be watched for three hours afterward. Administration of the drug is tightly controlled, and doctors, patients and health facilities have to be approved before being allowed to use it.
Lilly shares were down 18 cents early Tuesday afternoon, to $52.18 each.