FDA Reports on Deaths from ADHD Drugs

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.

According to an article carried on APA’s PsycPort, an FDA panel is to discuss new ways of examining the potential cardiovascular risks of drugs for treating ADHD, including amphetamines such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin and Metadate:

The few studies that have looked at longer-term use of ADHD drugs provide little information on those risks, the FDA said. The cardiovascular risks include heart attack, stroke, hypertension, palpitations and arrhythmia.

Sales of drugs to treat ADHD have increased sharply in recent years, with use growing at a faster rate among adults than children, according to a recent study by Medco Health Solutions, a prescription benefit manager. Spending on ADHD drugs soared from $759 million in 2000 to $3.1 billion in 2004, according to IMS Health, a pharmaceutical information and consulting firm.

Death and injury reports led the FDA’s Canadian counterpart, Health Canada, to yank the ADHD drug Adderall XR from the market for six months last year.

A Canadian panel eventually concluded there was inadequate evidence of increased harm from Adderall XR compared with other available therapies – a conclusion the FDA also reached based on data on hand.

In reporting on the recent review of deaths from ADHD drugs, the article goes on to say:

The FDA review released Wednesday found fewer than one adverse event – that is, a death or serious injury – per one million ADHD drug prescriptions filled. Also, in some of the 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 drugs for ADHD “warrants close monitoring.” One possibility would be to add labeling to the drugs that would recommend that doctors consider the benefits and risks of prescribing the drugs to patients with heart problems, the report concluded.

Also see our recent article on the methylphenidate transdermal patch, to be marketed shortly under the brand name Daytrana: “ADHD Patch to be Sold as Daytrana”.

All clinical material on this site is peer reviewed by one or more clinical psychologists or other qualified mental health professionals. This specific article was last reviewed or updated by Dr Greg Mulhauser, Managing Editor on .

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