Washington – Twenty-five people died suddenly and 54 others suffered serious cardiovascular problems after taking drugs to treat attention deficit hyperactivity disorder between 1999 and 2003, the government says.
Children accounted for 19 of the deaths and 26 of the cases of nonfatal cardiovascular problems, including heart attack, stroke, hypertension, palpitations and arrhythmia, according to a Food and Drug Administration report released Wednesday.
The report came a day before an FDA panel was to discuss new ways of examining potential cardiovascular risks of the drugs, which include amphetamines such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin and Metadate.
The few studies that have looked at longer-term use of the drugs provide little information on those risks, the FDA said. The cardiovascular risks include heart attack, stroke, hypertension, palpitations and arrhythmia.
The FDA review released Wed nesday found less than one adverse event – a death or serious injury – per one million ADHD drug prescriptions filled. Also, in some cases, the children who died were later found to have had undiagnosed heart conditions.
However, the report noted, the rare occurrence of sudden death in children treated with the drugs “warrants close monitoring.”
