The US Food and Drug Administration has begun an initiative to rewrite the labels on drugs prescribed for attention deficit hyperactivity disorder (ADHD) to reflect the agency’s concern about possible side effects, including hallucinations and suicidal tendencies.
The problem they face is in wording the labels to reflect that this issue is a concern, not a likelihood, or all out “black box” warning. The estimated frequency of severe psychological problems among ADHD patients is about 1 in 5000, but it is unclear to everyone on the FDA’s pediatric advisory panel as to whether these occurrences are due to medication or if they would have developed on their own.
ADHD is a disorder that affects concentration and the ability to stay on task to the extent that it interferes with academic or professional performance. Patients with ADHD have trouble with impulse control and are easily excited.
The FDA wants the labels to be a fuller discussion of 135 reports outlining the potential adverse effects caused by drugs like Concerta and Ritalin. Current labeling mentions some of the psychiatric problems associated with the medications, but FDA officials believe the wording is unclear as to the frequency and types of psychiatric problems.
“The agency is struggling,” said Dianne Murphy, director of the FDA’s office of pediatric therapeutics. “We have a concern, but we may not be able to articulate it with certainty.”
The 135 adverse event reports spanned from December of 2003, to January of 2005. The reports primarily investigated Concerta, made by Johnson and Johnson, and Ritalin, made by Novartis AG.
Thirty-six adverse psychological events caused significant concern among the panel reviewing the reports. After taking Concerta, some patients reported hallucinations, suicidal thoughts, and suicide attempts. Only six patients had a history of mental illness. Six other patients improved once they stopped taking Concerta.
FDA officials said it wasn’t clear if Concerta caused the problem or if the problems would have developed on their own.
