To: fresc who wrote (490 ) 2/11/2005 11:14:23 PM From: fresc Read Replies (1) | Respond to of 42652 This is the latest drug to be pulled in Canada but not in America. Aleeve was recently banned along with Vioxx. Once again American lobbyists (pharma) doing what they do best. It's getting scary... Adderall XR—Shire’s brand of extended-release neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d,l-amphetamine aspartate monohydrate—was removed from the Canadian market yesterday because of concerns about sudden deaths, heart-related deaths, and strokes in children and adults taking the usual recommended doses of the product. Health Canada took the action after reviewing 20 international reports of sudden death in patients taking recommended doses of Adderall XR or Adderall, the immediate-release formulation that is marketed in the United States but not Canada. While acknowledging that sudden unexplained deaths (SUD) have been associated with amphetamine abuse and reported in children with underlying cardiac abnormalities taking recommended doses of amphetamines, FDA said in a statement that it “cannot conclude that recommended doses of Adderall can cause SUD, but is continuing to carefully evaluate these data.” FDA added, “A very small number of cases of SUD have been reported in children without structural cardiac abnormalities taking Adderall.” FDA posted to its Web site clinical details about 12 cases of pediatric SUD in boys taking Adderall or Adderall XR that have been reported during the past 5 years. While no deaths in Canada have been associated with use of Adderall XR, Health Canada explained in a statement on its Web site that a preliminary review of safety data for medications used to treat attention-deficit/hyperactivity disorder (ADHD) showed a higher incidence of serious adverse reactions leading to death with Adderall and Adderall XR combined than with other agents in this class. Canadian patients taking Adderall XR should be switched to alternative ADHD agents, Health Canada advised. Remaining product should be returned to pharmacies for disposal, the agency noted.