FDA Requires Label for ADHD Medication Strattera To Include Black Box Warning
Strattera, an attention deficit hyperactivity disorder treatment manufactured by Eli Lilly, will carry a "black box" warning based on a review of earlier clinical trials that found the drug might increase suicidal thoughts in children and adolescents, FDA and Lilly officials said Thursday, the New York Times reports.
Lilly researchers reviewed data from 12 company-sponsored studies involving a total of 2,208 children and adolescents. The review found that five of 1,357 patients -- or 0.4% -- who took Strattera experienced suicidal thoughts severe enough to report to their doctors (Carey, New York Times, 9/30). One child taking Strattera in the trials attempted suicide (CQ HealthBeat, 9/29).
None of the 851 patients who received placebos experienced suicidal thoughts (Sternberg, USA Today, 9/30). The analysis found no evidence of increased suicidal thoughts among adults taking Strattera (Lumpkin, AP/Philadelphia Inquirer, 9/30).
In a statement, Lilly said the study found a "small but statistically significant increased risk of suicidal thoughts among Strattera-treated children and adolescents" (Gustin, New York Post, 9/30).
About 3.4 million adults and children have been prescribed Strattera -- the only nonstimulant treatment available for ADHD -- since it was approved by FDA, and about 75% of those taking the medication are children, Lilly officials said.
FDA in a statement 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." FDA also requested that Lilly develop a guide for doctors and pharmacists to give to patients who take Strattera (Lumpkin, AP/Long Island Newsday, 9/29).
The black box warning likely will discuss the clinical trial analysis, but the exact wording still is being discussed by Lilly and FDA. The agency also is conducting a study of the link between suicidal thoughts and other ADHD drugs, including Concerta, manufactured by Johnson & Johnson; Adderall, manufactured by Shire Pharmaceuticals; and Ritalin, manufactured by Novartis, all of which are stimulants (Corbett Dooren, Dow Jones/Wall Street Journal, 9/30).
However, experts say there is little reason to believe stimulant ADHD drugs carry the same risks as Strattera, which acts more like an antidepressant. FDA last year required drug makers to place black box warnings on antidepressants after research found a link between the drugs and an increased risk of suicidal thoughts among children and adolescents.
John Hayes, vice president of Lilly Research Laboratories, said, "We believe Strattera is a safe and effective treatment option, and [ADHD] has its own risks for people who stop taking the medication based on something they hear. We are advising people who have concerns to consult their physician."
William Pelham, director of the Center for Children and Families at the State University of New York-Buffalo, said, "This and other label changes for ADHD drugs only reinforce the notion that parents and clinicians should be conservative in treating the disorder and use drugs after trying other things, like psychosocial techniques, not before" (New York Times, 9/30).
However, Harold Koplewisz, a professor of child and adolescent psychiatry at the New York University School of Medicine, said, "We are talking about a medication that may make some children and teenagers uncomfortable, which is very different than a lethal situation like a gun in a house." He added that while "suicidal thoughts in adolescents [are] part of the normal experience," all children and adolescents taking psychiatric drugs should be monitored (AP/Long Island Newsday, 9/29).