 |
 |
 |
 |
 |
 |
 |
 |
 |
|
DRUG LABELING FDA Told to
Delay ADHD Drug Labeling Changes A release posted on the drug agency's Web site noted that members of the Pediatric Advisory Committee, in a meeting Thursday, did not come across any new concerns about psychiatric side effects with Concerta and other methylphenidates, which include Ritalin and Metadate. They also suggested that the FDA wait until more safety data has been collected on two other types of drugs used to treat ADHD -- methamphetamines such as Adderall and the non-stimulant Strattera. The FDA should "delay the drug labeling change until they have a good sense of class effect," Acting Committee Chairman Robert Nelson, of The Children's Hospital of Philadelphia, told FDA officials during the committee meeting, which was convened by the agency. "We heard there is no terrible signal," Office of Pediatric Therapeutics Director Dianne Murphy said in the release. "None of what I have heard today about these medications has made me particularly concerned," committee member Thomas Newman, of the University of California-San Francisco, said in the release. The FDA was
considering drug labeling changes to all methylphenidates with regard
to psychiatric events and potential cardiovascular side effects.
A review had found 36 psychiatric events for Concerta, compared
to 16 for Ritalin and other methylphenidates. Concerta had 20 cardiovascular
event reports, while the other methylphenidates had four such reports. The FDA's decision
to take a closer look at these medications has not surprised some
experts. Another expert believes drug labeling changes may not be the answer. "Drug labeling is an oversimplification of the problem," said Dr. Eugenio M. Rothe, director of the child and adolescent psychiatry clinic at Jackson Memorial Hospital and an associate professor of psychiatry at the University of Miami School of Medicine. "It scares people, and it doesn't address the other problems that are affecting the outcome. The problem is much more complex than that, and has to do primarily with the stigma associated with mental health conditions." This is just
the latest chapter in the ongoing debate over the safety of ADHD
medications. The FDA, however, elected only to require the company to update Adderall's label to warn that it should not be used in anyone with structural cardiac abnormalities. "The FDA is pursuing additional means to better characterize the cardiovascular risks for all drug products approved for ADHD," it said in a statement. Other ADHD drugs would also be scrutinized for psychiatric adverse events, the statement said. That review of amphetamine products and Strattera won't be brought to the advisory committee's attention until early 2006. The FDA stressed in its statement that it did not want to steer doctors and patients from one class of ADHD drugs with possible side effects to another class of ADHD drugs for which there is incomplete safety data. Almost 2 million children in the United States have been diagnosed with ADHD, according to the National Institute of Mental Health.
|
|
-
FDA |
