American drug regulators announced they would keep Adderall available for treating attention deficit hyperactivity disorder, even as Canadian authorities moved to pull the medication from shelves.
Health Canada suspended the drug's market authorization in early 2005 after its British manufacturer, Shire Pharmaceuticals, reported 14 child deaths and six adult deaths tied to the medication. The agency cited sudden deaths, cardiac events, and strokes occurring at standard prescribed doses.
The US Food and Drug Administration said it had reviewed the same adverse-event data and found no basis to restrict the drug or revise its labeling. The agency had earlier added a caution advising against use in patients with structural heart abnormalities.
Shire said it would comply with the Canadian order but strongly disputed the regulator's conclusions. Around 11,000 patients in Canada were taking the drug at the time. Adderall contains amphetamines in a timed-release formulation, the standard delivery method for most ADHD medications.
Historical summary. TurkishPress restated this AFP wire report, first published in February 2005, in its own words.