Cymbalta Attorneys
FDA MED WATCH: [Posted 10/17/2005]
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).
What is Cymbalta?
Cymbalta is an antidepressant medication. It affects chemicals in the
brain that may become unbalanced and cause depression.
Cymbalta is used to treat major depressive disorder (MDD) and for nerve
pain in the feet, legs or hands due to nerve disease in people with diabetes
(diabetic peripheral neuropathic pain).
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