ADHD drugs get new scrutiny from the FDA

Troubling psychiatric and cardiac occurrences lead to drug label changes.

By Susan J. Landers, AMNews staff. Aug. 1, 2005.

Washington -- Despite new safety concerns by the Food and Drug Administration about a commonly prescribed stimulant medication to treat children with attention-deficit/hyperactivity disorder, the drug should remain a treatment option, according to the agency.

The FDA's review of Concerta, a once-a-day form of methylphenidate, marketed by McNeil Consumer & Specialty Pharmaceuticals, a subsidiary of Johnson & Johnson, uncovered instances of troubling psychiatric and cardiovascular occurrences that will result in label changes regarding these safety concerns.

The company is committed to providing patients with safe and effective medications, said a representative for McNeil. They will work with the agency to evaluate any concerns about the drug, he said.

Meanwhile, the agency also is broadening its examination of post-marketing reports to include other stimulants approved for treating ADHD, as well as Strattera (atomoxetine) a nonstimulant manufactured by Eli Lilly and Co. The results of this FDA review likely will be brought before the agency's Pediatric Advisory Committee early next year.

The advisory committee heard the FDA's concerns about Concerta during its June 30 meeting.

For decades, physicians have been prescribing stimulants for patients with ADHD -- believed to affect 3% to 5% of all children, according to the National Institute of Mental Health.

Among the psychiatric events uncovered by the FDA's post-marketing review of children who took Concerta were suicidal thoughts, hallucinations, and psychotic behavior. Cardiovascular events included hypertension, fainting and arrhythmias.