By: Shute, Nancy, McGrath, Anne, U.S. News & World Report, 00415537, 2/20/2006, Vol. 140, Issue 6
Alarmed by 25 sudden deaths in people taking certain drugs for attention deficit hyperactivity disorder, an FDA panel last week recommended a "black box" warning that the drugs might cause cardiovascular problems. The FDA also found 54 nonfatal problems, including heart attack and stroke in adults and children on Ritalin, Adderall, Concerta, and other stimulants. It's not clear whether the drugs were at fault; some people had high blood pressure and other underlying issues. People with heart problems and hypertension are already cautioned about stimulants. For others, for now, "I don't think the risk in any way justifies not using it, "says Larry Diller, a pediatrician and author of Running on Ritalin. Millions take the drugs safely each day, he notes.
Mixed messages on ADHD , USA Today, 07347456, FEB 15, 2006
Parents can face conflicting advice on drugs' safety
Section: Life, Pg. 13b
Parents who are concerned about the heart risks of stimulants to treat attention deficit/hyperactivity disorder may hear conflicting advice from doctors, depending on whom they consult.
Last week, an advisory panel to the Food and Drug Administration voted 8-7 to suggest adding the agency's strongest warning label to Ritalin, Adderall and similar medications. The panel based its decision on an FDA report that found 25 children and adults had died suddenly from 1999 to 2003 after taking ADHD drugs.
Steven Nissen, an advisory committee member, says many of the 4million people who use the drugs may not realize that they have serious side effects. "I want parents and doctors, before they prescribe amphetamines and amphetamine-like drugs to children, to think a little harder whether they need them," says Nissen, interim chairman of the Cleveland Clinic's department of cardiovascular medicine.
Nissen suggests patients ask their doctors questions such as: "Do I really need these drugs? Am I on the lowest possible dose? Are there safer alternatives?"
The FDA typically follows the advice of its advisory committees. But Thomas Laughren, director of the FDA's division of psychiatry products, says it would be unusual for the agency to issue a "black box" warning based on such thin evidence. He notes that the reported number of sudden deaths in patients taking stimulants is lower than the figure that experts would expect to see among people who aren't taking the drugs. A second FDA committee, which focuses on pediatrics, will consider the drugs' safety next month, Laughren says.
Edward Hallowell, a doctor and co-author of Driven to Distraction, notes that about one in 10 of his patients stop using stimulants for ADHD because of side effects, which can include loss of appetite, abnormal heartbeats, elevated blood pressure, tics and twitches. "These meds are far from perfect," Hallowell said in an e-mail. "But they are the best medication option we have and are very safe when used correctly."
Worried patients have been calling David Goodman for several days. Goodman, an assistant professor of psychiatry at the Johns Hopkins University School of Medicine, says he sees no reason for his patients to stop taking the drugs. Goodman notes that teenagers who do not treat their ADHD face risks because such children are more likely than others to use drugs, drop out of school or get into accidents.
Lawrence Diller, author of Running on Ritalin and Should I Medicate My Child?, notes that people often rush to use medications for problems that might be addressed by changing parenting strategies, exploring special education or improving classroom management. These non-medical options can help some children avoid prescription medications and allow others to reduce their doses.
Although stimulants might seem like an easy fix, Diller says, "just because it works doesn't make it an ethical substitute for giving kids the proper attention at home and school."
(c) USA TODAY, 2006
Warnings advised on ADHD drugs , USA Today, 07347456, FEB 10, 2006