Citing concerns about possible psychiatric side effects, the FDA said it will add new label warnings to a class of drugs used to treat attention-deficit hyperactivity disorder (ADHD).These medications, called methylphenidates, include the widely prescribed Concerta. Two other types of drugs, methamphetamines, which include Adderall, and the non-stimulant atomoxetine (Strattera), are also used to treat ADHD. Almost 2 million children in the United States have been diagnosed with the disorder, according to the National Institute of Mental Health."Post-marketing reports received by FDA regarding Concerta and other methylphenidate products include psychiatric events such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior,” the agency explained in documents posted on its Web site.The Associated Press reported Wednesday that the FDA found 36 cases of psychiatric side effects among children using Concerta."We intend to make labeling changes describing these events,” the FDA said in its documents.The agency’s pediatric advisory committee is to meet Thursday to discuss the proposed labeling changes.
