Lilly Warns of Suicidal Thoughts With ADHD Drug


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 in a statement. 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.

About 5 million U.S. children, or 7 percent, are diagnosed with ADHD, which is marked by inattentiveness and impulsive behavior. In the past few years, some doctors have said the condition is over diagnosed, partly to keep active children calm in the classroom. Sales of ADHD drugs quadrupled between 2000 and 2004, according to a Medco Health Solutions Inc. report.

``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,''said Alan Breier, vice president and chief medical officer at Lilly, in a statement.

It's unclear if the risks will 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 by the FDA, works by increasing the amount of a chemical between brain cells that helps neurons communicate.

FDA Review

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.

That review prompted warnings last year 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 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.

(What is not clear is whether that (5x) amount was prescribed for the child )

Sales

The global ADHD market is about $1.7 billion. Strattera prescriptions are down about 10 percent over last year.