FDA Staff Cites Safety Concern with Lilly Drug

Excessive sedation is a “serious safety concern” with an experimental, long-acting form of Eli Lilly and Co’s blockbuster Zyprexa schizophrenia medicine, U.S. drug reviewers said in an analysis released on Monday.

Food and Drug Administration staff said the injectable formulation, called Zyprexa Adhera, was shown to be effective for acute and long-term treatment of schizophrenia.

The analysis was released ahead of a meeting by a panel of outside advisers who will evaluate the drug on Wednesday.

“Excessive sedation events are a serious safety concern because of the severity of excessive sedation, the unpredictable characteristics, and relatively high incidence - 0.07% of injections and 1.3% of patients,” FDA staff said.

Lilly, in a separate summary, said it believed the benefits of the long-acting formulation outweighed the risks.

“Although there are important additional safety considerations associated with the injection, they are manageable with appropriate labeling and risk-minimization activities,” the company said.

The FDA staff and Lilly summaries were posted on the agency’s Web site at http://www.fda.gov/ohrms/dockets/ac/08/briefing/2008-4338b1-00— index.htm.

(Reporting by Lisa Richwine, editing by Lisa Von Ahn and Gerald E. McCormick)