The Wall Street Journal (2/5, D6, Dooren) reports that an official from the Food and Drug Administration (FDA) "said that a long-acting, injectable form of Eli Lilly & Co.'s top-selling drug Zyprexa (olanzapine) was effective at treating schizophrenia, but caused 'profound sedation' in certain patients." In a memo posted on the agency's website, Thomas P. Laughren, M.D., the agency's psychiatry products division director, said that "clinical studies of the drug showed 24 out of 1,915 patients exposed to the long-acting form of Zyprexa suffered from profound sedation after receiving the injection," with the sedation "typically last[ing] about one to three hours."

        According to Bloomberg (2/5, Lopatto), an "FDA advisory panel meets Feb. 6 to consider whether Lilly should be allowed to sell" the once-a-month version of Zyprexa. Last December, the FDA found that "sleepiness was a 'particular concern' with the monthly injection," occurring "in 1.3 percent of patients." Dr. Laughren noted that the sleepiness may be "caused by doctors accidentally injecting the medicine into a blood vessel rather than into muscle," thus causing a "rapid release of the drug." Consequently, Eli Lilly has "proposed labeling that would require one-hour observation after the shot," and "also suggested [that] patients not operate machinery, and watch for signs of side effects for three hours." Additionally, Lilly "proposed a study of 5,000 people to observe side effects after the drug goes on sale."

        In its Health Highlights section, HealthDay (2/5) notes that "[c]urrently, Zyprexa has FDA approval as an oral, once-daily medication to treat schizophrenia and bipolar disorder." The "short-acting, injectable form of the drug," however, "is used to treat agitated, non-cooperative patients with schizophrenia or bipolar mania." At its meeting on Wednesday, the "FDA panel will also decide whether long-acting Zyprexa should carry a 'black box' warning if it's approved," or if the agency "should consider approving it as a second line of treatment after other therapies fail to help patients." While the FDA typically adopts the requirements of its advisory panels, it is not required to do so.