FDA Warns about Suicidal Thinking in Children and Adolescents on ADHD Drug - Strattera

The Food and Drug Administration warned doctors on Thursday about reports of suicidal thinking in some children and adolescents who are taking Strattera, a drug used to treat attention deficit hyperactivity disorder (ADHD).

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. Similar warnings will be added to the drug’s labels in other countries.

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.”

“The actual risk is very low,” said Dr. Thomas Laughren, head of the FDA’s psychiatric drug unit. Despite the warning, he said, “FDA still views Strattera as an effective drug.”

Eli Lilly said it provided the FDA results from Strattera clinical trials 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.

Strattera, debuted as an alternative for Ritalin. Ritalin (another popular ADHD drug), is a stimulant, a class of drug that can be addictive.

Strattera is not a stimulant and hence not addictive. But its chemical makeup is similar to certain antidepressants.

A review of other ADHD drugs is continuing, Laughren said.

About 3.4 million patients — adults and children — have been prescribed Strattera since it became available, with Lilly officials saying about 75 percent of those taking the medication are children.

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