Who at the FDA really cares what those advisory committees think? The FDA has nixed Eli Lilly's plans for a long-acting formulation of its antipsychotic Zyprexa, once again ignoring an advisory committee vote. Eli Lilly's troubles with the drug appear to be related to a small number of cases of "profound sedation" among patients taking the injected drug. When the committee voted, those cases had been restricted to a few hours of profound sedation after injection. But since then, another case was reported when the sedation affect occurred three to five hours after injection. And that's what the agency cited in the non-approvable letter.
For its part, Lilly suggests the adverse effects may have been triggered by physicians who injected the drug into the patient's blood stream, rather than muscle. But the agency is demanding more data before it hands out an approval.
The bad news came as Eli Lilly was preparing for its first civil case on Zyprexa from a patient suing over the side effects of the drug, which include weight gain and diabetes. Analysts say the verdict could affect Lilly's reported negotiations for a big settlement over the drug with states and the federal government.
- see this release
- read the report in the Wall Street Journal
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Zyprexa--Top 10 Warnings and Recalls. Report