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The Food and Drug Administration has warned five manufacturers of drugs for attention-deficit/hyperactivity disorder against using what it terms “false or misleading” promotional materials that overstate the drugs’ efficacy and downplay risks.
The warnings, contained in letters sent in late September to the makers of Adder-all XR, Concerta, Focalin XR, Methylin, and Strattera, “cite issues we’ve been seeing across the promotion for this therapeutic area,” said FDA spokeswoman Sandra Walsh in an interview.

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Ms. Walsh said the letters to the five manufacturers, which were developed together, were part of the FDA’s “routine monitoring of drug ads and promotional materials” and did not signal forthcoming additional FDA enforcement action against the companies. Regulators “had some concerns with promotion of one product in that class,” Ms. Walsh said. ‘As a procedural process, we decided to look at all the drugs in that class.” She declined to name the drug that prompted the review.
In the letters, the FDA’s division of drug marketing, advertising, and communications cites promotional materials for Adder-all XR, Methylin, and Focalin XR that imply the drugs can reduce negative consequences potentially seen with ADHD, such as poor social-emotional development and job problems, and poor academic performance. Meanwhile, promotional materials for Strattera imply that the drug will reduce the likelihood of substance abuse disorders, car accidents, and injuries, along with “impulsive sexual behavior,” the FDA said. And promotional materials for Concerta imply that the drug has a positive effect on adolescents’ ability to pursue interests outside of school, it said.
All these assertions are unsupported by the evidence and therefore are misleading, the FDA said.
In addition, the FDA specifically warned Eli Lilly & Co., which manufactures Strattera, about its sales claims surrounding co-morbid ADHD and anxiety. Eli Lilly has used a professional sales aid for Strattera that includes the phrase “not contraindicated in patients with anxiety” and also includes a graph showing the mean change from baseline, for Strattera and placebo, on the Hamilton Anxiety Rating Scale.
“These presentations are misleading because they suggest or imply that Strattera is safe and effective for the treatment of anxiety, or, at a minimum, for the treatment of anxiety in the distinct sub-population of patients with coexisting ADHD and anxiety, when in fact, Strattera is not indicated for treatment of anxiety in either population,” the FDA’s letter said.
Anxiety has been reported in patients treated with Strattera, the FDA said, “and there is concern that symptoms such as anxiety may represent precursors to emerging suicidal impulses.” Strattera’s label includes a black box warning about the risk of suicidal ideation in children and adolescents.
BY JANE ANDERSON
Contributing Writer
COPYRIGHT 2008 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning