New warning labels may be required on drugs for attention deficit hyperactivity disorder (ADHD) following the deaths of 25 people who died after beginning treatment with the increasingly popular medicines.
The deaths occurred between 1999 and 2003, according to a report on Wednesday from the Food and Drug Administration (FDA). Nineteen of them involved children. The report also detailed 54 cases of serious cardiovascular problems in adults and children being treated with ADHD drugs.
Some of these ADHD drug-treated patients had pre-existing heart conditions or hypertension. That could lead to new warning on the labels on the drugs, the FDA said.
The drugs include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin and Metadate.
The FDA said it has tallied an additional 26 deaths between 1969 and 2003 in ADHD patients involving death by suicide, intentional overdose, drowning, heat stroke and from underlying disease.
The regulatory agency asked its Drug Safety and Risk Management advisory committee to discuss the feasibility of different ways of studying whether the deaths are linked to use of the drugs, as well as specific ways of conducting such studies. The few studies that have looked at longer-term use of ADHD drugs provide little information on those risks, the FDA said.
Republican Senator Chuck Grassley criticized the FDA's pace earlier this week.
In a letter sent on Monday to acting FDA commissioner Doctor Andrew von Eschenbach, Grassley said in part, "I remain concerned that while both psychiatric and cardiovascular risk signals have cropped up across this class of drugs this past year, it appears that FDA is just now beginning to `discuss approaches' for studying these risks."
An FDA review found fewer than one case of death or serious injury per 1 million ADHD drug prescriptions filled, with one exception: 1.79 cases per million of nonfatal cardiovascular or cerebrovascular problems in adults treated with amphetamines.
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.
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