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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

Black Box Warnings May Be Avoided By ADHD Drugs

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Manufacturers of ADHD drugs are probably feeling good right now. Things don’t look as bleak for them as they did several weeks ago. In February of this year, the Drug Safety and Risk Management advisory committee of the FDA, recommended that Ritalin and other ADHD drugs should carry “black box” warnings about the risks of those drugs. However, recently the FDA’s pediatric advisory committee rejected making such a recommendation. Instead, the pediatric committee simply called for easier to understand language on the labels. The decision of the pediatric committee comes despite the widespread use of ADHD drugs. Last year over 3.3 million young people under the age of 19 used an ADHD drug. Those drugs include Ritalin, manufactured by Novartis Pharmaceuticals, Strattera, made by Eli Lilly and Adderall produced by Shire Pharmaceuticals. Some reports indicate a connection between psychiatric and cardiovascular events with use of ADHD drugs. The FDA usually follows the recommendations of its advisory committee, though it is not obligated to do so. It is unclear how a decision will be made between opposing recommendations from two different committees.