The Food and Drug Administration plans to add new warnings about psychiatric side effects to the label of Concerta and other drugs for attention deficits and hyperactivity, according to documents posted on the FDA Web site and confirmed by the agency.
At a meeting today of the FDA’s Pediatric Advisory Committee, officials will discuss safety concerns about Concerta, a form of methylphenidate, the active ingredient in Ritalin and similar medications.
A briefing document about the meeting says the review was prompted by reports of hallucinations, suicidal thoughts, psychotic behavior and aggression among methylphenidate users. Officials note that Concerta’s label already lists possible psychiatric side effects but suggests the problems aren’t serious or that the drug might only aggravate existing problems.
The FDA also has received reports of cardiovascular problems among Concerta users, such as high blood pressure, arrhythmia and racing heartbeats. The agency doesn’t yet know whether these problems are caused by the drug.
Attention-deficit hyperactivity disorder (ADHD) affects about 7.5% of school-age children, Concerta’s maker says. The drug, approved in 2000, is intended to improve concentration and impulse control. Patients filled 7.8 million prescriptions last year, the FDA report says.
The agency also plans to examine other stimulants used to treat ADHD, including amphetamines and Strattera. Last year, the FDA changed the label for Adderall XR to include risk of sudden cardiovascular death, especially in children with heart disease, the report says.
Bonnie Jacobs of McNeil Consumer & Specialty Pharmaceuticals, a division of Johnson & Johnson that makes Concerta, says the company is reviewing the information and “will of course do what is in the best interest of patients.”