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Old 09-29-05, 01:57 PM
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Exclamation FDA Warns About ADHD Drug Strattera

By JOHN J. LUMPKIN, Associated Press Writer
The Food and Drug Administration warned doctors Thursday about reports of suicidal thinking in some children and adolescents who are taking Strattera, a drug used to treat attention deficit hyperactivity disorder.

Manufacturer Eli Lilly & Co. announced that a black-box warning will be added to the drug's label in the United States. Such a warning is the most serious that can be added to a medication's label, and similar warnings will be added to the drug's labels in other countries. The company said a study showed instances of suicidal thinking were rare.

In a statement, the FDA said it "is advising health care providers and caregivers that children and adolescents being treated with Strattera should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed."

Eli Lilly said it provided the FDA results from a Strattera clinical trial of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Strattera attempted suicide, the company said.

There was no evidence of increased suicidal thoughts in adults taking Strattera, which also goes by the generic name atomoxetine, the Indianapolis-based company said.

The warning is the result of a larger FDA review of psychiatric drugs and their possible association with suicide, the agency said.

Strattera has been available since 2002 and been used by more than two million people, the FDA said.

The drug won praise from some doctors and parents when it became available because, unlike Ritalin, it is not a stimulant, a class of drug that can be addictive. But its chemical makeup is similar to certain antidepressants, which last year were associated with an increased risk of suicide.

Attention deficit hyperactivity disorder affects as many as 7 percent of school-aged children and 4 percent of adults in the United States.

Strattera's worldwide sales have dropped lately, falling 31 percent to $123.5 million during this year's second quarter from a year earlier.

Lilly warned doctors in December to stop using Strattera in patients with jaundice or who show signs of liver problems, and it placed a warning on the label and in prescribing information after at least two patients on the medication developed liver problems.

Still, the company says it believes the drug is safe.

"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, Lilly's chief medical officer, in a statement. "Lilly continues to view Strattera as a safe and effective treatment option, and those doing well on the medication should be able to continue their treatment with confidence."

Associated Press reporter Ashley M. Heher in Indianapolis contributed to this report

http://news.yahoo.com/s/ap/20050929/...E0BHNlYwN0bWE-
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Old 09-29-05, 02:09 PM
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From Foxnews.com...




Lilly to Put Suicide Warning on Strattera Label
Thursday, September 29, 2005



CHICAGO Eli Lilly and Co. (LLY) Thursday said it will add strong warnings to its label for Strattera (search), 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 (search), 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 Food and Drug Administration (search) 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 on the New York Stock Exchange, amid a slight decline for the drug sector.


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