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Shire Pharmaceuticals speaks out on FDA ADHD review

Date published: 13/02/2006

Following a US Food and Drug Administration (FDA) review into attention-deficit hyperactivity disorder (ADHD) drugs Shire Pharmaceuticals has moved to speak out. The FDA advisory panel said that ADHD treatments should carry black-box warnings that they could be linked to a greater risk of sudden death from cardiovascular side effects.

Although there is no conclusive data on risks the FDA panel opted for its strictest warning that could affect Shire's Adderall, Novartis' Ritalin and Concerta made by Johnson & Johnson. A Shire statement said: "As the leader in ADHD treatment, Shire is supportive of the goals of yesterday's meeting of the US FDA Drug Safety and Risk Management Advisory Committee. "However, we feel it is important to put several of the issues into perspective."

The firm pointed out that data regarding the reported incidence rates of serious cardiovascular adverse events, both in patients taking ADHD medicines and those not taking ADHD medicines, were reviewed and the reported incidence rates were similar in both groups. It added: "Shire believes that the interests of physicians and patients would be better served by further study to determine whether there is, in fact, a relationship between these medicines and cardiovascular events.

"Obtaining this information is crucial prior to taking what would be an unprecedented action to include something in a black box that is not been supported by sufficient data." Adderall already carries a black-box warning for amphetamine abuse or misuse safety concerns and warns of the risk of sudden death in patients with structural cardiac abnormalities. Shire said: "We stand behind this labelling and believe that further action is unwarranted."

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