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FDA Issues Advisory on ADHD Drug Strattera

Rare Reports of Suicidal Thinking Cited; Drug to Get 'Black Box' Warning Label

Review's Findings

The advisory comes after a review and analysis of 12 studies conducted in children with ADHD and one trial in children with bedwetting that identified an increased risk of suicidal thinking for Strattera, says the FDA.

The FDA told Lilly to review its database and studies on the drug, which included more than 2,200 patients - 1,357 of whom had received Strattera and 851 of whom had received a fake drug (placebo).

The analysis showed that 0.4% of children treated with Strattera reported suicidal thinking (five children out of 1,357) compared with no cases in children treated with the placebo.

One patient taking Strattera in those trials attempted suicide, note the FDA and Lilly.

The increased risk of suicidal thinking with Strattera in the trials is "small but statistically significant," says Lilly.

What's on the Warning Label

Based on the data, the FDA has determined that the following points are appropriate for inclusion in the boxed warning:

  • Strattera increases the risk of suicidal thinking in children and adolescents with ADHD.
  • Anyone considering the use of Strattera in a child or adolescent for ADHD must balance the increased risk of suicidal thinking with the clinical need for the drug.
  • Patients who are started on therapy should be observed closely for clinical worsening, suicidal thinking or behaviors, or unusual changes in behavior.
  • Families and caregivers should be advised to closely observe the patient and to communicate changes or concerning behaviors with the prescriber.

Drugmaker's Statement

"Lilly's top priority is to help doctors, patients, and their families make informed treatment decisions, so we are reaching out extensively to educate physicians and the public about this product label change," says Alan Breier, MD, vice president and chief medical officer at Lilly, in a news release.

"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," Breier continues.

"Also important for parents to know is that 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," he says.

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