FDA probes long-acting Zyprexa safety after 2 patients die

Two patients have died unexpectedly after their Zyprexa Relprevv injections, and the FDA is now investigating. The agency says the patients died three to four days after receiving "an appropriate dose," and both had "very high" blood levels of olanzapine, the long-acting Zyprexa product's active ingredient.

Under a risk-management plan imposed when Zyprexa Relprevv was approved in 2009, patients are supposed to be monitored continuously for at least three hours after each injection. High doses can stop patients' hearts, send them into respiratory arrest, sedate them heavily and cause delirium, the FDA said in a statement. The atypical antipsychotic's official label warns of the risk of "post-injection delirium sedation syndrome," caused when the drug enters the blood too quickly.

"In the clinical trials supporting the approval of Zyprexa Relprevv, cases of PDSS were observed within three hours after administration .. but there were no deaths due to PDSS," the FDA said. "These two patients died three to four days after receiving an appropriate dose of the drug, and it is not clear whether they died from PDSS."

Made by Eli Lilly ($LLY), Zyprexa Relprevv is a follow-up to the company's blockbuster antipsychotic Zyprexa. The long-acting injectable version isn't a big seller for the company; Lilly doesn't even itemize its sales, just reports the total Zyprexa franchise revenue, which amounted to $1.3 billion last year. The Relprevv version is, however, still on patent, so it's selling at brand prices without generic competition. Its key patent expires in 2018. Its selling point is that long-acting injections help keep patients on schedule with their meds, particularly important for patients with schizophrenia.

Zyprexa itself has come under plenty of FDA scrutiny. After years of reports of weight gain in Zyprexa patients, the FDA investigated, and the drug now carries a label warning of the risk of weight gain and metabolic problems. Lilly faced thousands of lawsuits from Zyprexa patients claiming the drug caused them to develop diabetes; the company wrapped up most of them in a $1.2 billion settlement. The company also paid $1.42 billion to resolve a Justice Department investigation into its Zyprexa marketing practices.

- read the FDA statement

Special Reports: Eli Lilly - Zyprexa - Pharma's Top 11 Marketing Settlements | Eli Lilly - 10 Largest U.S. Patent Losses | Olanzapine - Top U.S. Generic Blockbusters

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