May 01, 2007
FDA eyes Lilly Zyprexa data: NY Times
The FDA is examining whether Eli Lilly provided it with accurate data about the side effects of its antipsychotic drug Zyprexa, The New York Times reported.
The FDA has questions about a Lilly document from February 2000 in which the company found that patients taking Zyprexa in clinical trials were three and a half times as likely to develop high blood sugar as those who did not take the drug.
The document was not submitted to the agency. But a few months later Lilly provided data to the FDA that showed almost no difference in blood sugar between patients who took Zyprexa and those who did not, The Times reported.
The agency said it had not yet decided whether to take any action against Lilly.
“The FDA continues to explore the concerns raised recently regarding information provided to the FDA on Zyprexa’s safety,” Dr. Mitchell Mathis, a deputy director in the psychiatry division of the agency’s center for drug evaluation and research said.
Lilly spokesman Phil Belt told The Times the company had rechecked its database and found errors in the original statistics. The data submitted later was accurate, Belt said.