Sept. 29 (Bloomberg) -- Eli Lilly & Co. warned doctors and patients that children and adolescents taking the Strattera medication for attention deficit/hyperactivity disorder may have a higher risk of suicidal thoughts.
Five cases of suicidal thinking and one attempted suicide were found among 1,357 children in trials, the Indianapolis- based company said today. No deaths were reported. Lilly will put a warning on Strattera's label, which was updated in December to include the risk of liver damage.
``We believe that parents are very sensitive to safety issues for ADHD drugs and that a new warning could further add to pressure on the product,'' Friedman Billings Ramsey analyst David Moskowitz wrote in a note to clients today.
About 5 million U.S. children, or 7 percent, are diagnosed with ADHD, a disorder marked by inattentiveness and impulsive behavior. Recently, some doctors have said ADHD is over diagnosed, partly to keep active children calm in the classroom. The global ADHD market is about $1.7 billion, said Gloria Tsuen, an analyst at First Investors Corp. in New York.
It's unclear if the risks apply to other ADHD drugs, such as Shire Pharmaceuticals Group Plc's Adderall, Novartis AG's Ritalin and Johnson & Johnson's Concerta. Those drugs work as stimulants. Strattera, the first of its class approved for sale, works by blocking the body's absorption of the chemical norepinephrine in the brain, leaving more of it to help control attention and activity levels.
Shares
Shares of Lilly rose 20 cents to $53.67 at 11:27 a.m. in New York Stock Exchange composite trading. Before today, the stock has lost 5.8 percent so far this year.
Strattera generated $124 million in sales in the second quarter, down 31 percent from the year-earlier period. Moskowitz said in his report that he reduced 2006 Strattera sales estimates to $518 million from $685 million. He also lowered his 2006 earnings estimate to $3.05 a share from $3.10, based on lower expectations for the ADHD drug.
``Strattera is one of the key drivers'' for Lilly, said Tsuen, who helps manage about $3.5 billion. `This is one more piece of bad news for the drug.''
The newest change in the labeling of Strattera resulted from a U.S. Food and Drug Administration review of psychiatric treatment for children, Lilly said.
Other Warnings
Last year, that review prompted warnings about suicide risk from anti-depression drugs that include Wyeth's Effexor, GlaxoSmithKline Plc's Paxil, Pfizer Inc.'s Zoloft, Forest Laboratories Inc. and H. Lundbeck A/S's Celexa and Lexapro and Lilly's Prozac.
There appears to be no risk to adult patients taking Strattera, the company said. About 4 percent of American adults also have the condition.
The risk represents about 0.4 percent of the total population of Straterra patients, said Lilly Chief Executive Sidney Taurel in an interview on financial news network CNBC. One child who took five times the recommended dosage attempted to kill himself, Taurel said.
Lilly also reiterated its earnings guidance for the year today, saying it would have 2005 earnings per share of $1.90 to $1.96, including a product liability charge of 90 cents per share. Sales growth is expected to be in the 6 percent to 8 percent range.
To contact the reporter on this story:
Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net
Last Updated: September 29, 2005 11:28 EDT
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