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

FDA Panel Recommends Strongest Warning for ADHD Drugs

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An advisory panel of the FDA voted to recommend “black box” warnings on popular drugs used to treat attention deficit hyperactivity disorder. The warning would indicate that the drugs may be linked to an increased risk of death and injury. A “black box” warning is the strongest warning available for prescription drugs, and this recommendation comes after reports of 25 deaths, including 19 children, who had taken ADHD drugs. The drugs used to treat ADHD include Ritalin, Concerta, Adderall, Adderall XR, Methylin and Metadate. The FDA advisory panel also recommended that the ADHD drugs include a medication guide for patients and parents. Concerta is made by Johnson & Johnson; Adderall by Shire Pharmaceuticals; Ritalin by Novartis Pharmaceuticals; Methylin by Mallinckrodt Pharmaceuticals; and Metadate by UCB. Various other companies make generic versions of Ritalin.

ADHD drugs are prescribed to about 2 million children and 1 million adults a month. Sheller, Ludwig & Badey is investigating claims of cardiovascular injury related to ADHD medications. If you, or someone you know, has been prescribed Ritalin, Concerta, Methylin or Metadate, and has suffered a cardiovascular injury, including heart attack, contact us using the form at right.