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.
According to Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs, the agency will issue a public health advisory within days in response to an article in the New England Journal of Medicine that links use of drugs like Paxil, Prozac, and Zoloft late in pregnancy with a condition that can endanger infants’ lives.
With 42 million sleeping pill prescriptions filled last year — up some 60 percent since 2000 — experts are warning that the drugs are being overused and may be encouraging doctors to overlook other causes of sleeplessness, such as depression. Behind the increased use of sleeping pills are advertising campaigns costing hundreds of millions of dollars.
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.
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