FDA to Examine New Ways to Study ADD Drugs
By ANDREW BRIDGES, Associated Press Writer Wed Jan 4, 7:35 PM ET
WASHINGTON - Reports of sudden deaths, strokes, heart attacks and hypertension in both children and adults taking drugs to treat attention deficit hyperactivity disorder are spurring new government study into the medications' safety.
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.
The Food and Drug Administration said it had received reports of what it called "serious adverse events" — including deaths — in association with the therapeutic use of the drugs. The agency considers the reports "rare though serious," FDA spokeswoman Susan Bro said Wednesday.
The FDA's Canadian counterpart, Health Canada, yanked the ADHD drug Adderall XR from the market for six months last year in response to reports of 20 sudden deaths and 12 strokes in adults and children using the drug. A number of the cases involved children with structural heart defects.
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