The move comes after the U.S. Food and Drug Administration (FDA) issued a health advisory bsaed on clinical trials conducted on the drug.
According to BusinessWeek, Lilly says that reports of suicidal thoughts by children and adolescents taking the drug were rare. Details on the labeling are being worked out with the FDA, along with regulators in Europe and Australia.
Dr. Thomas Laughren, director of the FDA's division of psychiatry products, says that, "The risk for any individual patient taking this drug is quite low, but from a public health standpoint, four [cases] per thousand is a fairly big signal, given there are tens of thousands of patients taking this drug... We do think that prescribers and patients need to be aware of this risk that we've just discovered."
