FDA says Shire overstated ADHD drug benefit

Shire P.L.C. overstates the benefits of Intuniv, its drug for attention deficit hyperactivity disorder in children, in promotional materials, U.S. regulators said.

The company has operations in Chester County.

Brochures in a patient starter kit for the drug make "unsubstantiated effectiveness claims" and "omit and minimize important risk information," the Food and Drug Administration said in a June 22 letter to the company posted today on the agency's website.    - Bloomberg News
A spokeswoman for Shire didn't immediately return telephone calls seeking comment.