‘ADHD’ at Psychology, Philosophy and Real Life, Page 3

Breaking with the FDA’s Drug Safety and Risk Management advisory committee, which voted last month to require ‘black box’ labelling on ADHD drugs such as Ritalin, the organisation’s pediatric advisory committee has recommended that ADHD drugs should not have to carry the government’s strongest warning about potential cardiovascular and psychiatric risks.

Timothy Wilens, an associate professor of psychiatry at Harvard Medical School, says most doctors who prescribe ADHD drugs are already aware that they can trigger psychosis, a rare side effect. Now an advisory panel will discuss whether the Food and Drug Administration should ask makers of attention deficit/hyperactivity disorder drugs to add labelling information about the possible risk of psychosis or mania, especially in children.

Last week, an FDA advisory committee voted to recommend adding ‘black box’ safety warnings to ADHD drugs. This week, the director of the FDA’s division of psychiatry products says it would be unusual for the agency to issue a ‘black box’ warning based on such thin evidence. A second FDA committee, which focuses on pediatrics, will consider the drugs’ safety next month.

It’s official: an FDA science advisory committee has voted to recommend the most serious type of ‘black box’ warning labels for Ritalin and other stimulants used in the treatment of attention deficit hyperactivity disorder.

Twenty-five people died suddenly and another 54 suffered serious cardiovascular problems after taking drugs to treat attention deficit hyperactivity disorder between 1999 and 2003, according to a report from the US government’s Food and Drug Administration. The report says that children accounted for 19 of the deaths and 26 of the cases of nonfatal cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia.