Lilly to add suicide risk warning to drug label

CHICAGO (Reuters) – Eli Lilly and Co. on Thursday said it
will add strong warnings to its label for Strattera, used to
treat attention-deficit/hyperactivity disorder, including the
risk of suicidal thoughts among children and adolescents.

Strattera will now carry a “black box” warning, the
strongest required by U.S. regulators. Such warnings typically
hurt sales of products by raising concern among doctors and
patients about the safety of a drug.

The Indianapolis drugmaker said a review of clinical trials
data identified a small but statistically significant increased
risk of suicidal thoughts among Strattera-treated children and
adolescents.

Five cases of suicidal thoughts were seen among 1,357 young
patients, compared with no cases among 851 patients taking
placebos during trials.

“While suicidal thinking was uncommon in patients on the
medication during clinical trials, it is important for parents
to be aware it can occur, and to discuss any unusual symptoms
with a physician,” the company said in a release.

There were no suicides among children, adolescents or
adults taking the medication during the trials. But there was
one suicide attempt among the 1,357 children and adolescents
studied, the company said.

The new label warning comes after the U.S. Food and Drug
Administration asked Lilly to submit an analysis of safety data
from its clinical trials.

The company said it is working with the FDA to complete the
language on the label. It also is working with regulators
outside the United States.

Attention deficit disorder affects 3 percent to 7 percent
of school-age children, Lilly said. Symptoms include
inappropriate attention and concentration, as well as
hyperactivity.

Lilly stood by its sales and earnings outlook for the year,
saying it expects full-year earnings per share of $1.90 to

$1.96.

Shares of Lilly rose 12 cents to $53.59 in morning trade on
the New York Stock Exchange, amid a slight decline for the drug
sector.

(Additional reporting by Ransdell Pierson in New York)