ADHD Drug Comes Under Scrutiny From ParentsMar 29, 2005 | AP Parents whose children take Adderall XR for Attention-Deficit Hyperactivity Disorder (ADHD) face a dilemma :whether to let their kids stay on a medicine that could be unsafe when experts say there is a lack of long-term research to guide the decision.
The popular drug, which has been linked to 20 sudden deaths worldwide, mostly in children, has been taken off the Canadian market, sparking questions about whether kids in the United States should be using it.
The Food and Drug Administration issued a public health advisory on its Web site saying that the rate of sudden death for children on Adderall XR is no higher than for those not on the drug. But children with heart defects could be at higher risk.
Parents are making decisions about stimulants such as Adderall XR with few facts, says Julie Magno Zito, an epidemiologist at the University of Maryland. There are no good long-term studies of such medicines, she says. Rare side effects of a drug won't surface in short studies unless they include a huge number of kids, such as in a national HMO, and that kind of study hasn't been done on Adderall XR, Zito says.
About 700,000 children in the United States take Adderall XR, a timed-release stimulant, and 300,000 use Adderall, a version that often needs to be taken more than once a day, according to Shire Pharmaceuticals Group PLC, maker of the drug.
Parents whose kids are doing well on Adderall might consider a "wait and see" approach for now, says Baltimore pediatrician Richard Gorman. "School failure is a big issue for kids with ADHD, and these are very rare effects so far."
Of the 20 reports of sudden death, 12 were in the United States from 1999 to 2003, a time frame when 30 million prescriptions were written for the medicine, according to the FDA advisory.
More deaths could be reported in the wake of Canada's decision to pull the drug off shelves. On the other hand, the withdrawal could be rescinded if harmful effects are confirmed to be rare, Gorman says.