Shire hit by new drug warning from FDA

US regulators have slapped another warning on drugs for attention deficit hyperactivity disorder (ADHD), including Shire Pharmaceuticals' top-selling Adderall XR drug.

In a staff memo, the Food and Drug Administration said the hyperactivity drugs should carry stronger warnings about the risk of side effects such as hallucinations and paranoia. "Signs and symptoms of psychosis or mania, particularly hallucinations, can occur in some patients with no identifiable risk factors," the memo said. It was posted on the FDA's website before a meeting of the regulator's Paediatric Advisory Committee next Wednesday.

The FDA report talked about a seven-year-old boy who, after taking ADHD drugs, thought he was seeing people sitting in a rocking chair and people coming into the house and stealing Christmas presents. Another five-year-old boy reported seeing snakes and polka-dot alligators.

A spokesman for Shire said none of the information was new. He added it was too early to speculate on the outcome of next week's meeting, especially because the agenda had not been published yet. "We don't know if it will come back with a recommendation for ADHD drugs to carry stronger warnings about their risks," he said. In any case, the FDA does not always follow recommendations by its advisory panels. The spokesman reiterated Shire's stance that "any type of enhanced warning should be based on scientific data. There is not enough data at the moment to warrant enhanced warnings."

Last month, the FDA's Drug Safety and Risk Management Advisory Committee highlighted the heart risks of ADHD drugs. The panel voted by 8-7 that the drugs, including Shire's Adderall and Novartis's Ritalin, should carry "black box" warnings highlighting the risk of heart attacks.

But agency officials seemed taken aback by the vote, especially because they had not asked the committee to address the drugs' labels. Thomas Laughren, director of the Division of Pyschiatry Products at the FDA, said at the time: "We don't think anything different needs to be done right now. We think the labelling right now is adequate."

Shire, led by Matthew Emmens, has been trying to reduce its reliance on Adderall by investing in a raft of new drugs and is targeting five new launches by the middle of next year.