Pharmacy Times, Volume 0, 0

Stimulants that are used totreat attentiondeficit/hyperactivitydisorder(ADHD) will havestronger warninglabels, accordingto an FDA mandate.The labelswill warn againstthe use of the medications in adultsor children with heart problems andwill notify physicians that they cancause 1 child in 1000 to experiencehallucinations. The warnings will befound on Adderall (Shire PharmaceuticalsGroup), Concerta(McNeil Pharmaceuticals), andRitalin (Novartis).

Although these warnings are notas strong as those approved earlierthis year by an FDA advisory committee,they significantly strengthenthe risk information already on thelabels. The warnings are a result ofreports of sudden death in childrentaking the drugs. In some reports,the children were later determinedto have had structural defects of theheart. The new warnings willinclude, in part, "Sudden deaths,strokes, and myocardial infarctionhave been reported in adults takingstimulant drugs at usual doses."