Magazine article Clinical Psychiatry News

Atomoxetine Gets Black Box despite Dearth of Data: FDA Cites Increased Risk of Suicidality

Magazine article Clinical Psychiatry News

Atomoxetine Gets Black Box despite Dearth of Data: FDA Cites Increased Risk of Suicidality

Article excerpt

The Food and Drug Administration's public health advisory on a potential increased risk of suicidal ideation in children and adolescents taking atomoxetine is a cautious move, given the paucity of data. But the data should not be ignored, several experts told CLINICAL PSYCHIATRY NEWS.

The FDA has instructed Eli Lilly & Co. to place a new black box warning on atomoxetine (Strattera) and to develop a medication guide that explains potential risks to patients and caregivers.

Previously, the FDA had instructed the company to search its databases for adverse psychiatric events associated with atomoxetine, including suicidal ideation or behavior. The agency identified a small but statistically significant increased risk of suicidal thinking with atomoxetine, compared with placebo.

Atomoxetine, marketed as the first nonstimulant for the treatment of attention-deficit hyperactivity disorder (ADHD) is not the only ADHD drug to come under FDA scrutiny. Manufacturers of other ADHD drugs, including methylphenidate and the stimulants, were recently asked to review their databases as well. Word on whether a similar increased risk of suicidal ideation and/or behavior exists is not expected until next year, according to an FDA spokesperson.

In the atomoxetine study, 6 children were identified in the Eli Lilly database and clinical trials--5 with suicidal ideation and 1 who attempted suicide--among 1,357 patients taking the drug, for a rate of 0.4%. There were no cases of suicidal ideation or behavior among 851 patients taking a placebo.

"In the FDA analysis, there was only one child who did anything, and it was a small overdose where the intention was not clear," said Mina K. Dulcan, M.D., director of the division of child and adolescent psychiatry at Northwestern University, Chicago.

Dr. Dulcan, a member of the Lilly Straterra Global Advisory Board, said the black box warning is more severe than is warranted based on the data. "The signal is very weak, and the black box is very scary," she said.

David Fassler, M.D., said any risk of potential suicide ideation or behavior should be taken seriously. But in the case of atomoxetine, the risk appears to be extremely low. "There were no actual suicides in the studies. We're talking about a small number of children, but we certainly shouldn't ignore it. We need to understand what it really means," said Dr. …

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