| FDA to parents: Don't toss ADHD drugs yet |
Weigh risks before taking children off prescriptions, agency urgesWASHINGTON - Federal health regulators are urging parents to keep their children on attention deficit drugs like Ritalin and Adderall, despite new evidence in government-backed study that the stimulants can increase the risk of sudden death.Published Monday in the American Journal of Psychiatry, the study suggests a link between use of the stimulant drugs and sudden death in children and adolescents. The drugs already carry warnings about risks of heart attack and stroke in children with underlying heart conditions, but researchers have questioned whether they pose the same risks to children without those problems. Healthy children taking the medications were six to seven times more likely to die suddenly for unexplained reasons than their peers, according to the study from the National Institute of Mental Health. The study was partially funded by Food and Drug Administration, but agency experts said its methods — which relied on interviews with parents years after a child's death — may have caused errors. The agency urges parents to discuss safety concerns with their doctor, but to keep children on the treatments. "Since the deaths occurred a long time ago, all of this depended on the memory of people — relatives and physicians — involved with the victims," said Dr. Robert Temple, the FDA's director of drug review. Discuss concerns, but keep kids on treatment The FDA said it is collecting data for a larger, more in-depth study of the drugs' risks. "We're not sure this study tells us something we didn't know," Temple said of Monday's publication. "We didn't think it gave an unequivocal answer as to whether there is such a risk." About 2.5 million U.S. children currently take drugs for attention deficit and hyperactivity disorder, according to government researchers. Among the most popular brands are Shire's Adderall, Novartis' Ritalin and Dexedrine, marketed by various manufacturers. Sales of the drugs topped $4.8 billion last year, according to health care analysis firm IMS Health. The most popular brands include Shire's Adderall, Johnson & Johnson's Concerta and Novartis' Ritalin. |
