Drug company Eli Lilly has issued a new label for the antidepressant, known generically as duloxetine, which also includes reports of hepatitis, jaundice and other liver-related problems in patients using the drug.
The information is displayed on the U.S. Food and Drug Administration web site.
In a letter to doctors in early October the company said there had been some reports indicating that patients with pre-existing liver disease who take duloxetine may have an increased risk for further liver damage.
Cymbalta, which is also approved to treat a type of nerve damage caused by diabetes, has been known to cause liver problems.
The initial label also warned against using the drug with alcohol.
According to the new label, Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.
Results of the study will be presented Oct. 20 at 2 p.m. at a joint meeting of the American Academy of Child and Adolescent Psychiatry and the Canadian Academy of Child and Adolescent Psychiatry in Toronto.
Pavuluri says the findings have direct clinical implications for present and future medication trials and cognitive behavioral therapy used to treat children with bipolar disorder.
Pediatric bipolar disorder, also known as manic depression, is associated with sexual promiscuity, failure in school, addiction and suicide. The disorder is characterized by extreme changes in mood and is often misdiagnosed. Patients may alternate between depression and euphoria, or mania.
Other UIC researchers in the study were Subhash Aryal, Megan O'Connor, Erin Harral, Ellen Herbener, and senior collaborator John Sweeney.
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