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FDA to probe ADHD drug safety

Jan 5, 2006 | Pharma Times

The US Food and Drug Administration is planning to review the cardiovascular risks of attention-deficit hyperactivity disorder treatments, and has asked an advisory panel to discuss the issue at a meeting on February 9-10.

The move follows reports of sudden deaths, strokes, heart attacks and high blood pressure in both children and adults taking drugs to treat ADHD, according to the agency.

Last June, the FDA announced an investigation into the safety of ADHD products based on the stimulant drug methylphenidate, including Johnson & Johnson's once-daily Concerta product, and said it was considering extending the review to include all ADHD treatments on the market. But the agency was subsequently advised to hold back on any label changes until it was established whether the reported side effects were common to all drugs in the class.

"The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks," said the FDA. The Drug Safety and Risk Management Advisory Committee will be asked to discuss approaches that could be used to study whether these products increase the risk of adverse cardiovascular outcomes.

Use of ADHD drugs is expanding rapidly in the USA, according to a report published last year by pharmacy benefits company Medco. Prescribing swelled 23% among young adults (aged 20-34), with a 40% in the amount spent on these prescriptions, while use older adults also climbed, up 33% in adults aged 39-49 and 36% in those aged 50-64.

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