FDA looks at excessive sleepiness with Eli Lilly’s Zyprexa

INDIANAPOLIS The Food and Drug Administration has stated that Eli Lilly’s schizophrenia drug, Zyprexa, when taken through an injection, has risks that include excessive sleepiness, according to published reports.

People with schizophrenia taking a monthly injection instead of daily tablets already on the market may experience “profound sedation,” staff of the FDA said in documents posted today on the agency's Web site. The sleepiness is a “serious safety concern” because of its severity and “relatively high” incidence, the FDA said.

An FDA advisory panel plans to meet Feb. 6 to consider whether Lilly should be allowed to sell the monthly Zyprexa. The company is investing in new and reformulated products because the original Zyprexa may face generic competition as early as 2011.

Sales of Zyprexa tablets, also used to treat bipolar disorder, rose 9 percent to $4.76 billion last year.