INDIANAPOLIS Eli Lilly has updated the U.S. product labels for two of its patented medications, the company announced Friday.
As part of its ongoing discussions with the FDA, the company has updated its labels for Zyprexa and Symbyax. Both medications, which are used to treat mental disorders, were shown to pose a threat to patients, according the company’s clinical trial data. The risks included potential weight gain and elevations in blood sugar and lipid levels, although they had been previously listed on the drugs’ warning labels since they entered the pharmaceutical realm.
Lilly said it would be communicating the updates to U.S. physicians through a “Dear Healthcare Practitioner” letter. The company also said in a press release that they would be notifying “consumer advocacy and professionally focused associations about this label change so they can provide important information to patients.” In addition to the outreach to various health organizations, Lilly added that it is in the process of corresponding the data involved with the updates to regulatory agencies outside of the United States.
“Today’s communication is part of Lilly’s historical and ongoing commitment to inform doctors and patients about updated prescribing information,” said Sara Corya, M.D., global medical director, Lilly. “Zyprexa is an important treatment option for patients suffering from the devastating effects of schizophrenia and bipolar disorder, as is Symbyax for patients with bipolar depression. This information will continue to help healthcare professionals evaluate and make the best treatment decisions for individual patients.”
In the meantime, new labeling information was released on the products’ Web sites.