FDA points out limits of ADHD study

Research shows that kids using ADHD meds are several times more likely to die suddenly as children who aren't taking the drugs. But the FDA says parents shouldn't pull their children off the meds with posthaste. Despite the fact that it and the NIH paid for it, the agency is pointing out the new study's flaws--an ironic move.

The FDA says that the study doesn't provide enough evidence to show the drugs are dangerous. Here's one reason why: The agency questions the fact that so few patients in the study actually were on stimulant drugs like Ritalin for ADHD. The research focused on 564 kids who had sudden and unexplained deaths and 564 who died in traffic accidents. Ten of the sudden-death kids were on ADHD meds; only two of the car-accident kids were. "Given the limitations of this study's methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children," the agency said in a statement.

Nonetheless, the FDA's safety review of these medications--which include Shire's Adderall and Adderall XR and several more--is ongoing. The agency is co-sponsoring a large study with the Agency for Healthcare Research and Quality, which is looking at the potential for increased risk of heart attack, stroke or other cardiac problems associated with stimulant meds in kids. These results are due later this year.

- read FDA's statement
- see the Washington Post story
- check out the coverage in the Wall Street Journal