FDA plans stronger warning for ADHD drug

WASHINGTON — The government is planning to strengthen warnings about possible psychiatric side effects from Concerta and related treatments for attention-deficit hyperactivity disorder, and is probing whether other ADHD drugs need updating, too.

At a meeting today of the Food and Drug Administration's Pediatric Advisory Committee, officials will discuss safety concerns about Concerta, a form of methylphenidate, the active ingredient in Ritalin and similar medications.

For years, those drugs' labels have listed possible psychiatric side effects, such as agitation, psychosis or transient depression.

But a routine FDA review of Concerta's use in children turned up more reports of psychiatric reactions than anticipated, including some that aren't explicitly labeled, such as suicidal thoughts, hallucinations and violent behavior. A subsequent review of all methylphenidate products found similar reports.

The FDA can't say if the drugs actually cause those side effects — the reports are from a database of reactions reported by medication users that make such determinations very difficult.

But, in a statement posted on its Web site, the agency said it intends to strengthen the labeled warnings for all methylphenidate products.

Currently, the drugs' labels may downplay the seriousness of psychiatric side effects, and suggest they're only a risk in people who've already experienced psychiatric disorders, wrote FDA drug safety evaluator Kathleen Phelan.

Indeed, stimulant drugs "may exacerbate symptoms and reveal them for the first time" in children with previously unrecognized psychiatric illnesses, she wrote.

But, among 36 cases of psychiatric side effects in child Concerta users, six report histories of psychiatric illness, three deny such histories and there's no information on the rest, Phelan wrote. Further investigation is needed to determine if such side effects may also occur in people without underlying illness, she added.

FDA said it doesn't intend to change the drugs' labels right away. It is investigating whether similar behaviors are seen with additional ADHD treatments, such as Adderall and Strattera — to avoid people switching drugs over the concern "based on incomplete safety assessments," said an FDA document prepared for today's meeting of the agency's scientific advisers. That probe should be finished early next year.

Concerta maker Johnson & Johnson declined immediate comment.