Eli Lilly and Company has announced changes to the labeling of Zyprexa and Symbyax, two brand-name atypical antipsychotics produced and sold by the company. Eli Lilly has updated the labeling to include more warning information on potentially harmful weight gain and blood sugar elevation that may result from taking the medications.
According to Eli Lilly, the label changes came about because of conversations with the FDA, as well as new analyses of the data from large clinical trials conducted by the company and others. The company will be sending a "Dear Healthcare Practitioner" letter to doctors about the new labeling, as well as informing consumer advocacy and professional associations.
Zyprexa is the brand name for olanzapine, while Symbyax is a mix of olanzapine and fluoxetine. Zyprexa is approved for use in treatment of schizophrenia and the mixed and manic portions of bipolar disorder, while Symbyax is approved for the treatment of bipolar depression.
Neither product is approved for patients with dementia, and they may increase the risk of death if used on elderly dementia patients. Nevertheless, in the past the company has marketed Zyprexa for treatment of dementia and for manic bipolar episodes.
One of the labeling changes focuses on unnatural weight gain from olanzapine. According to the company, the drug has been shown to lead to "significant and sometimes very high elevations in triglyceride levels."
The other major change is a stronger emphasis on the drug's effect on blood glucose levels. According to the company, atypical antipsychotics in general may lead to an increase in blood sugar levels, while olanzapine has an even greater effect than other such drugs. In some cases, patients treated with such medications have suffered complications including ketoacidosis, coma and even death.
In January, Eli Lilly settled 18,000 lawsuits from patients who alleged that using Zyprexa caused them to develop diabetes or other diseases. The company agreed to pay $500 million, bringing its total Zyprexa-related settlement costs to $1.2 billion.