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.
The FDA elected only to require the company to update Adderall’s label to warn that it should not be used in anyone with structural cardiac abnormalities. At the time, the agency told that it was satisfied with the safety profile of the medication.
While labeling changes to include information on psychiatric side effects seemed a certainty, the FDA appeared less sure about cardiovascular side effects.