Lilly adds warnings to Zyprexa and Symbyax

US drug major Eli Lilly added new warnings for weight gain and hyperlipidemia to the US labels on its antidepressants Zyprexa (olanzapine) and Symbyax (olanzapine and fluoxetine HCl). The firm also updated product information in the warning for hyperglycemia, including additional language on a greater association of increases in glucose levels with olanzapine than with some other atypical antipsychotics.

The updates reflect recently-completed pooled analyses of clinical trial data in adults and adolescents, information from two large non-Lilly studies of atypical antipsychotics (CATIE and CAFE) and discussions with the Food and Drug Administration. In a press release, Lilly stated that it continues to work with the FDA and will provide additional data and analyses as they become available.