The Food and Drug Administration said yesterday that it does not plan to follow the lead of Canadian regulators who took a drug for attention-deficit hyperactivity disorder off the market because of reports that it has been linked to 20 sudden deaths and a dozen strokes, including some among children.
The FDA said it has evaluated the reports on Adderall XR and does not believe the data warrant similar action in the United States.
In a statement, Health Canada said it is asking makers of related drugs to provide a thorough review of their worldwide safety data.
None of the deaths or strokes associated with Adderall XR were in Canada, department spokesman Ryan Baker said.
Of the 20 cases of sudden death linked to the drug, 14 involved children. Two of the 12 reported strokes were in children.
The drug is made by Shire Pharmaceuticals Group PLC, based in Basingstoke, England, and is sold in Canada and the United States. Shire's chief executive, Matthew Emmens, said in a statement late Wednesday that the company "remains confident in the safety and efficacy" of the drug.
Emmens said the FDA reviewed the same data as Health Canada last year and sought an additional warning that the drug should not be prescribed for people with "structural cardiovascular abnormalities."
About 700,000 people take Adderall XR in the United States, and 300,000 more use Adderall, Shire spokesman Matthew Cabrey said Wednesday.