A routine FDA review uncovered unexpected reports of psychiatric side effects resulting from the use of methylphenidate (Concerta, Ritalin), including several that have not been explicitly labeled, such as suicidal thoughts, hallucinations and violent behavior. The US agency says it intends to strengthen the labeled warnings for all methylphenidate products and is investigating whether similar behaviors are seen with other ADHD treatments, such as Adderall and Strattera.
The Associated Press reports that the FDA is planning to strengthen warnings about possible psychiatric side effects from Concerta and Ritalin (methylphenidate) and related treatments for attention deficit hyperactivity disorder.
Although the medications’ labels have long listed possible psychiatric side effects, such as agitation, psychosis or transient depression, a routine Food and Drug Administration review of methylphenidate’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 is careful to note that it is not known whether the drugs actually cause those side effects: the reports come from a database of reactions reported by medication users, making such determinations very difficult.
But, in a statement posted on its web site, the agency said it does intend to strengthen the labeled warnings for all methylphenidate products.
The FDA is now investigating whether similar behaviors are seen with other ADHD treatments, such as Adderall and Strattera, and it hopes to avoid people switching drugs over the concern “based on incomplete safety assessments”, according to an FDA document prepared for a meeting of the agency’s scientific advisers on Thursday.
The probe is expected to finish early next year.
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