On December 13, 2006, the FDA announced antidepressants prescribed to young adults are risky. The agency proposed expanding the labels of all antidepressants to include an expanded warning of suicidal thoughts in patients ranging from 18-24 years of age. The newly presented change would expand a warning now on the labels that pertain only to children and adolescents treated with antidepressant drugs. The new label changes would also contain a suggestion that patients of all ages be carefully monitored, particularly when starting antidepressant treatment. On October 17, 2005, Eli Lilly expanded its warning about potential liver-related problems with its depression drug, Cymbalta, and cautioned doctors against prescribing it to patients with chronic liver disease, U.S. health regulators announced. The new label for the drug also contains reports of hepatitis, jaundice and other liver-related problems in patients using Cymbalta.

Eli Lilly and FDA notified healthcare professionals of revision to the Precautions/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride), indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain. Postmarketing reports of hepatic injury (including hepatitis and cholestatic jaundice) suggest that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage. The new labeling extends the precaution against using Cymbalta in patients with substantial alcohol use to include those patients with chronic liver disease. It is recommended that Cymbalta not be administered to patients with any hepatic insufficiency.

The FDA and Eli Lilly have notified healthcare professionals of a significant revision to the Precautions/Hepatotoxicity section of the prescribing information for Cymbalta (duloxetine hydrochloride); Lilly's antidepressant indicated for treatment of major depressive disorder and diabetic peripheral neuropathic pain.

Cymbalta, which already carries a Black Box Warning regarding "Suicidality in Children and Adolescents," is now linked to post-marketing reports of hepatic injury (including hepatitis and cholestatic jaundice) that suggest "patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage."

Patients and prescribers should be aware of the signs and symptoms of liver damage (pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms).

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