Possible tie to attention-deficit-disorder meds
BY PAUL H.B. SHIN
DAILY NEWS STAFF WRITER
More than 500 children on medication for attention deficit hyperactivity disorder have reported bouts of psychosis, federal health officials revealed yesterday at a hearing to determine if tougher warnings were warranted for the popular stimulants.
And at least five kids on Adderall XR - one of the most prescribed ADHD drugs - have died from possible heart failure since it was approved for pediatric use in October 2004, the Food and Drug Administration said.
But the FDA's pediatric advisory panel yesterday last night decided the drugs did not need so-called "black box" warnings about the medications' risks.
Some experts had urged regulators not to demonize the drugs, which studies have shown are safe and effective for a vast majority of patients.
"The take-home message is likely to be that these are dangerous medicines. But that's really not supported by the evidence," said Dr. F. Xavier Castellanos, director of the Institute for Pediatric Neuroscience at the NYU Child Study Center.
"In many many cases it has a profound benefit," said Castellanos, who is not on the advisory panel. "It's never as good as we would want, but it's better than anything else we have."
Last month, another advisory panel urged the FDA to label the stimulants with the "black box" warnings - the agency's strongest safety caution - because of rare but potentially deadly heart problems. The issue has become a growing concern because more adults are now taking ADHD drugs.
From 2000 to last year, the number of adults ages 20 to 44 on ADHD medication jumped 164% among women and 119% among men, according to Medco Health Solutions, which manages pharmacy benefits for employers and insurance companies.
Originally published on March 23, 2006