LILLY ADDS WARNING TO STRATTERA LABELDec 20, 2004 | www.pharmexec.com Eli Lilly and Co. announced it has added a bolded warning to the product label for Strattera (atomoxetine hydrochloride) regarding two reported cases of severe liver injury.
The warning states that the drug, which is used to treat attention-deficit/hyperactivity disorder, should be discontinued if patients develop jaundice or laboratory evidence of liver injury.
There has been no evidence of liver injury in the approximately 6,000 patients who have participated in Strattera clinical trials, the company said. However, of the more than 2 million patients treated during the first two years after the drug was approved, there have been two reported cases of markedly elevated hepatic enzymes and bilirubin in the absence of other clear explanatory factors, the company said. Both patients recovered with normal liver function after Strattera was discontinued.
The company said in a small proportion of patients, severe drug-related liver injury could lead to acute liver failure, need for a liver transplant or death.
Pruritus, dark urine, jaundice, upper-right side abdominal tenderness or unexplained “flu-like” symptoms could be signs of liver dysfunction. If patients notice these symptoms, they should contact their physicians and undergo laboratory testing to determine liver enzyme levels.
Shares of Lilly closed at $56.02, down $1.38, or 2.4 percent, in heavy trading on the New York Stock Exchange.