HEALTHSafety of ADHD drugs is questioned once againPhysicians who prescribe stimulant drugs for the disorder express concern that heightened warnings could cause a drop in appropriate prescribing.By Susan J. Landers, amednews staff. March 6, 2006. Washington -- A Food and Drug Administration advisory committee recommended Feb. 9 that black-box warnings about possible heart risks be added to the labels of stimulant drugs that are often prescribed for children and adults with attention-deficit/hyperactivity disorder. But that's just the beginning of the story. Chapter 2 will unfold March 22, when the FDA's Pediatric Advisory Committee is scheduled to meet and likely will consider the necessity of such warnings. The FDA generally, but not always, heeds the advice of its advisory committees. Meanwhile, the recommendation by the Drug Safety and Risk Management Advisory Committee set off alarms for physicians and advocacy group members who expressed concern that a possible black-box warning on these drugs could cause a drop in appropriate prescribing. "If the FDA does decide to implement black-box warnings, I would expect to see a substantial decrease in prescriptions," said David Fassler, MD, clinical professor of psychiatry at the University of Vermont College of Medicine in Burlington. "This has clearly been the experience with respect to SSRI antidepressants, where prescriptions ... have decreased by approximately 25% over the past year." ADHD is one of the more common psychiatric conditions among children and adolescents, with nearly 4 million children ages 3 to 17 diagnosed with the disorder and about 2.5 million of them using medication. Increasing numbers of adults also are being prescribed the drugs. [...]Full text of American Medical News content is available to AMA members and paid subscribers.
Copyright 2006 American Medical Association. All rights reserved.
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