A US Food and Drug Administration advisory committee yesterday recommended that new warnings be added to the labelling of drug used to treat attention-deficit hyperactivity disorder.
The warnings should draw attention to the risk of adverse reactions to the products, including psychotic reactions, such as hallucinations, aggression and suicidality, as well as cardiovascular side effects, said the Paediatric Advisory Committee.
But the panel stopped short of recommending a ‘black-box’ warning – the strongest available on medicine labelling - for fear of alarming patients and preventing those who could benefit from the products from receiving treatment. It also said a medication guide should be drawn up to explain the risks to patients.
Last month, another FDA advisory panel voted in favour of adding a black-box warning about cardiovascular side effects to some ADHD products. The PAC disagreed with this view, but did recommend that current labelling warning of cardiovascular side effects, which appears on some ADHD drugs, be extended to all products used to treat the condition.
The FDA will now deliberate on the findings of both advisory committees before reaching a verdict on labelling.
Products affected by the review include conventional agents such as Novartis' Ritalin (methylphenidate), Shire's Adderall (mixed amphetamine salts), and Johnson & Johnson's Concerta (methylphenidate). But the PAC said the warning labels should be extended to all ADHD drugs, including newer products such as Eli Lilly’s Strattera (atomoxetine) and Cephalon’s Sparlon (modafinil).
The panel is due to review Cephalon’s application to market Sparlon for ADHD later today. Particular attention is expected to be given to a proposed risk management plan drawn up by the company to prevent serious skin rashes that have been observed with the drug.