Additional Safety Information for Some ADHD Drugs Needed
An FDA advisory committee on Wednesday said that pharmaceutical companies should make patients and physicians aware of the potential psychiatric and cardiovascular risks among children who take attention deficit hyperactivity disorder medications but did not call for a "black box" warning for such treatments as a previous committee had recommended, the Wall Street Journal reports (Wilde Mathews, Wall Street Journal, 3/23).
The committee on Wednesday recommended that the labels of ADHD medications include information about the potential risk for hallucinations among children who take such treatments. In addition, the committee recommended that FDA establish a "MedGuide" to tell parents to discuss with physicians whether their children should end treatment with ADHD medications in the event they experience hallucinations (Rubin, USA Today, 3/23).
The guide also should inform parents that ADHD medications can increase risk for aggressive behavior, psychosis and mania in children, as well as risk for heart attack, stroke and sudden death among those with undiagnosed heart problems (Reichard, CQ HealthBeat, 3/22). The committee recommended that FDA promote more voluntary reports of adverse events related to ADHD medications to the agency MedWatch system to produce more data about such problems.
At a hearing on Wednesday, Kate Gelperin, an FDA drug safety expert, told committee members that they should address the potential psychiatric risks of ADHD medications, adding that the agency has received a number of reports of "hallucinations, both visual and tactile, involving insects, snakes and worms," related to such treatments. She said that early estimates indicate as many as 6% of children who take ADHD medications might experience psychiatric side effects (Ginsberg, Philadelphia Inquirer, 3/23).
Rosemary Johann-Liang, deputy director of the division of drug risk evaluation at FDA, said, "We were struck by the hallucinations. We felt it was a drug effect" (Harris, New York Times, 3/23).
FDA officials also said that ADHD medications can cause "aggression, violent behavior and homicidal thoughts" (Philadelphia Inquirer, 3/23).
However, some psychiatrists and mental health advocates said that the benefits for children who take ADHD medications outweigh the risks.
Cynthia Wainscott, of the National Mental Health Association, said, "It is important to not let the discussion of ADHD medications overshadow the public health crisis of untreated mental health disorders in children" (Bridges, AP/Hartford Courant, 3/23).
ADHD medications are "overprescribed," which "invites side effects, such as insomnia, tension, or drug dependency," a USA Today editorial states, adding, "It also means the true problem might go untreated." According to the editorial, medical guidelines for the prescription of ADHD medications should require a "systematic attempt to change attitudes, so that the drugs are not the instant choice."
The editorial concludes, "Calibrating the right balance on ADHD will depend less on the actions of regulators and more on the attitudes of parents, teachers and doctors" (USA Today, 3/23).
Several broadcast programs reported on the committee recommendations on ADHD medications:
- CBS' "Evening News": The segment includes comments from Andrew Adesman, a physician at Schneider Children's Hospital; Steven Nissen, a cardiologist at the Cleveland Clinic; and a mother with two children who take ADHD medications (Kaledin, "Evening News," CBS, 3/22). The complete segment is available online in RealPlayer.
- NBC's "Nightly News": The segment includes comments from Nissen and Melvin Oatis, an assistant professor of clinical psychiatry at the NYU Child Study Center (Bazell, "Nightly News," NBC, 3/22). The complete segment is available online in Windows Media.
- NPR's "Morning Edition": The segment includes comments from Judith O'Fallon, a member of the committee; Temple; and parents with children who take ADHD medications (Silberner, "Morning Edition," NPR, 3/23). The complete segment is available online in RealPlayer.