Eli Lilly & Co.'s current label warning on health risks linked to its antipsychotic Zyprexa may not be strong enough, according to court documents.
Lilly added a warning to its packaging in October 2007 saying that more than half of patients in 13 studies gained an average of 12 pounds after taking the drug for less than a year. It also says Zyprexa is more ``associated'' with higher blood- sugar levels -- a risk factor for diabetes -- than similar medications.
The warning, approved by the U.S. Food and Drug Administration, may need to be adjusted to link Zyprexa more directly to higher blood sugar and diabetes, according to a letter to the Indianapolis-based drugmaker from the agency. The document was produced for a lawsuit by the state of Alaska claiming the company withheld information on risks of Zyprexa, Lilly's top-selling drug with sales of $4.76 billion last year.
``We anticipate that additional labeling changes will be necessary when we have reviewed the results of the additional analyses that we have requested,'' FDA administrator Tom Laughren wrote to Lilly in an Aug. 28 letter.
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