ROBERT SIEGEL, Host:
From NPR News, this is ALL THINGS CONSIDERED. I'm Robert Siegel.
MICHELE NORRIS, Host:
And I'm Michele Norris. An advisory panel to the Food and Drug Administration is recommending that the Agency put warning labels on commonly used drugs for ADHD, that's Attention Deficit Hyperactivity Disorder. The vote was close, eight to seven, and that shows just how tough some of the questions facing the agency are. Does it act in the face of no clear evidence, scaring some people who could be helped by these drugs? Or does it do nothing and risk that future studies will show that the drugs are indeed harmful. NPR's Joanne Silberner reports.
JOANNE SILBERNER: All drugs have what's called a risk-benefit equation. What the risks are compared to the benefits. Risks can outweigh benefits when people who don't really need a drug take it anyway. Or when a lot of people suffer side effects. Cardiologist Steven Nissen of the Cleveland Clinic says there are reasons to believe the ADHD drugs have more risks that is generally appreciated.
Mr. Nissen was on the FDA advisory panel. He started the discussion that led to the recommendation of a warning label for drugs like Adderall, Strateera, Ritalin, and Concerta.
STEVEN NISSEN: We know that these drugs increase heart rate and blood pressure. And there's a long history of information to suggest that if you raise blood pressure in individuals, particularly adults, you will increase the risk of stroke, heart attack, and even sudden cardiac death.
SILBERNER: Prompted by reports of 25 deaths in a four year period, mostly in children, the FDA initially asked the committee only for advice on how to study the safety of the drugs. It's hard to study the safety of a drug once it's on the market. Drug companies don't want to spend the money. Patients don't want to be randomly assigned to get or not get a drug they may feel they need.
Looking back through tens of thousands of patient records to see if there's a pattern is laborious. Nissen says a warning is needed now, because millions of people, including about 2.5 million children, are taking these drugs.
NISSEN: Why are physicians so willing to give the drugs? Well, it's because they think the drugs have no risks. And we felt we had to weigh in on rebalancing the understanding of benefit and risk.
SILBERNER: The FDA is also hearing from Capitol Hill. Republican Senator Chuck Grassley of Iowa earlier this week wrote a letter to the agency, urging it to take action. On the other side, the agency is hearing from psychiatrists like David Fassler, a clinical professor at the University of Vermont. He says while patients should be warned there may be a risk, the drugs are valuable in treating the inattentiveness, over-activity and impulsivity that mark ADHD. He says part of the risk-benefit equation is the risk of not treating.
DAVID FASSLER: ADHD is associated with a significant increase in the risk of accidents, including serious car accidents with permanent disability, and an increase in the incidence of substance abuse in adolescents when it's not treated. And when people get appropriate treatment, it significantly reduces the risk of these serious accidents and of substance abuse.
SILBERNER: Sorting this all out is likely to take awhile. Robert Temple is a top official with the FDA.
ROBERT TEMPLE: I think it's quite likely that while we're considering this, we'll get to the next meeting, which includes pediatric psychiatrists and pediatricians and we'll take what they think into account also.
SILBERNER: That meeting will occur in March. Temple says the agency's recent conclusion that one drug, Adderall, doesn't cause sudden death in healthy people doesn't mean that class of drugs are safe, but it does mean more work needs to be done to understand their risks.
Joanne Silberner, NPR News, Washington.
Copyright © 2006 NPR. All rights reserved. Visit our website terms of use and permissions pages at www.npr.org for further information.
NPR transcripts are created on a rush deadline by an NPR contractor. This text may not be in its final form and may be updated or revised in the future. Accuracy and availability may vary. The authoritative record of NPR’s programming is the audio record.