Panel Advises Disclosure of Drugs' Psychotic Effects
By GARDINER HARRIS
Experts said stimulants like Ritalin should carry a warning that children may suffer hallucinations of insects, snakes or worms.
GAITHERSBURG, Md., March 22 — Stimulants like Ritalin lead a small number of children to suffer hallucinations that usually feature insects, snakes or worms, according to federal drug officials, and a panel of experts said on Wednesday that physicians and parents needed to be warned of the risk.
The panel members said they hoped the warning would prevent physicians from prescribing a second drug to treat the hallucinations caused by the stimulants, which one expert estimated affect 2 to 5 of every 100 children taking them. Instead, they said, the right thing to do in such cases was to stop prescribing the stimulants.
On Feb. 9, a different advisory committee voted 8 to 7 to recommend that the Food and Drug Administration place its most serious warning label, a so-called black box, on the labels of stimulants to warn that they could have dangerous effects on the heart, particularly in adults. That recommendation grew out of reports that 25 people, mostly children, had died suddenly while taking the drugs.
The twin conclusions come more than 50 years after Ritalin was first approved to treat attention deficit disorder and hyperactivity. Since then, stimulants have become among the most widely prescribed medicines in the world. In the United States alone, about 2.5 million children and 1.5 million adults take them; as many as 10 percent of boys ages 10 to 12 do. <more>
http://www.nytimes.com/2006/03/23/health/23fda.html?_r=1&th&emc=th&oref=slogin