FDA eyes Lilly Zyprexa data: NY Times

Share this article:
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.
Share this article:

Email Newsletters

More in News

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.

GSK second-quarter sales disappoint

GSK second-quarter sales disappoint

Executives urge analysts to focus on the company's long-term potential.

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs ...

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union