A July 12 Health article on Concerta, a medication for attention-deficit hyperactivity disorder, incorrectly described psychiatrist Adelaide Robb as a member of the Food and Drug Administration's pediatric advisory committee. Robb presented testimony to the committee at its June 30 hearing. (Published 7/15/2005)
The Food and Drug Administration (FDA) plans to add a clear warning to Concerta, after a safety review turned up a small number of reports of hallucinations, suicidal thoughts and aggressive behavior as well as hypertension and chest pain in some children taking the attention deficit hyperactivity disorder drug. The warning, expected to appear early next year, will also apply to other drugs, like Ritalin, that contain the stimulant methylphenidate.
Experts appear split on the wisdom of the FDA's move.
"From a public health perspective, if you see there is something potentially harmful about Concerta, that is sufficient reason to issue a warning," said Larry Sasich, a pharmacist and consultant for Public Citizen's Health Research Group. But Russell Barkley, a professor of psychiatry at the Medical College of South Carolina and author of "Taking Charge of ADHD" (Guilford Press, 2000), called the FDA's response "out of proportion with the evidence."
Guessing Game Last year, 7.8 million prescriptions were written for Concerta, which is approved for use by children 6 and older. Adverse events that were reported between December 2003 and December 2004, according to the FDA review, included 13 cases of aggression, 10 of suicidal thoughts, 11 of chest pains, seven of depression and six of visual hallucinations in patients taking the drug. Such adverse-event reports typically understate the true incidence of a drug's negative effects, said Sasich. But, cautioned Adelaide Robb, a psychiatrist at Children's National Medical Center and a member of the FDA's pediatric advisory committee, "when you report an adverse event, you don't know whether it was caused by the medicine."
Review Ahead "Associating Concerta with depression is a red herring," said Barkley, who said 25 to 30 percent of those with ADHD will experience major depression by age 21. The FDA says it will conduct a safety review of all ADHD medications prescribed for children before changing the labels.
-- Matt McMillen