The problem Health Canada's decision last week to pull a popular attention-deficit drug off the market, citing reports linking it to 20 deaths between 1999 and 2003, has led parents to call their doctors to see if their kids should stop taking the stimulant. The U.S. Food and Drug Administration insists the drug, Adderall XR, made by Shire Pharmaceuticals, is safe when taken as directed.
The cautions According to the drug label, available at www.fda.gov, Adderall should not be given to patients with "structural cardiac abnormalities," such as heart murmurs; there have been reports of sudden death in children with such conditions. Adderall has not been tested in children under age 6. Fourteen of the deaths cited by Health Canada occurred in children; there were also 12 strokes (two of them in children).
Adderall helps tame impulsivity in ADHD patients like this boy, age 9. But recent alarms have scared parents.
(Photo Steve Liss/time Life Pictures/getty Images)
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The response Joseph Biederman, chief of pediatric psychopharmacology at Massachusetts General Hospital, said there was not enough data to link the deaths with Adderall XR. Even if Adderall were to blame, said Russell Barkley, professor at the Medical University of South Carolina and author of a book on ADD, "you have to put a denominator under this [death] number." According to the FDA, approximately 30 million prescriptions for Adderall were written during the four years in question. For a population this size, said the agency, this number of deaths is not unexpected.
But some doctors were exercising caution. Washington child psychiatrist Nora Galil said she was considering switching her patients to other drugs after fielding calls all day Friday. "You always have to be extra careful with kids, [and] if there's some smoke, you want to know if there's fire," she said.
What now? The FDA says it will continue to evaluate adverse event reports on Adderall. As always, consult with your doctor before you change a drug regimen. In two children's studies, stopping Adderall was tied to side effects including loss of appetite and insomnia.
-- Matt McMillen