Attention-deficit hyperactivity disorder (ADHD) drugs like Adderall, Ritalin, and Strattera need better medication guides to warn patients of the serious psychiatric and cardiac risks, government health officials said in a statement on Wednesday.
The medication guides would be provided to patients with their prescriptions and use simpler language than found on drug labels to discuss the possible risks. Drug manufacturers are expected to comply with the FDA request within 30 days.
ADHD drugs are widely used with annual sales exceeding $3.5 billion. An estimated 1.5 million adults and 3 million children take the popular drugs, despite ongoing concerns over their safety.
Last year, the FDA asked manufacturers to modify ADHD warning labels to include the risk of hallucinations—which affect approximately one in 1,000 children—and also to alert patients with heart problems of the potentially life-threatening side effects.
The drugs have been linked to an increased risk of heart attack, stroke, blood pressure problems, and sudden death. ADHD drugs have also been linked to a various psychiatric risks.
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