WARNING LABELS FOR RITALIN AND CONCERTA TO BE STRENGTHENED BY FDA IN RESPONSE TO REPORTS OF ADVERSE PSYCHIATRIC AND CARDIOVASCULAR SIDE-EFFECTS
June 30, 2005 08:44

Health Canada has suspended marketing of Adderall XR products from the Canadian market due to concern about reports of sudden unexplained death (SUD) in children taking Adderall and Adderall XR. SUD has been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, including Adderall and Adderall XR. In addition, a very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall. At this time, FDA cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data. (Read Risperdal Article)