U.S. drug safety reports linking an attention deficit drug to 20 deaths aren't enough for the Food and Drug Administration to follow Canada in taking the product off the market, the agency's director of medical policy said today.
Health Canada ordered the withdrawal yesterday of Adderall XR, made by Shire Pharmaceuticals Group Plc, based on its review of adverse-event reports previously given to the U.S. agency by the Basingstoke, England-based company. The drug is prescribed for children and adults with attention deficit hyperactivity disorder.
``The cases are not convincing evidence the drug is clearly responsible for these deaths,'' said Robert Temple, director of the FDA's office of medical policy, in an interview.
The drug, Shire's biggest product, will remain available in the U.S., its largest market, Temple said. House and Senate committees have been probing the FDA's monitoring of drug safety since antidepressants were linked to increased risk of suicide in children and Merck & Co. withdrew its Vioxx painkiller after a company study tied it to heart risks.
FDA Discouraged Withdrawal?
``Information conveyed to my staff suggests that during a recent Adderall meeting, one or more FDA employees requested that the Canadian government refrain from suspending the use of Adderall XR because there was concern that FDA could not handle another `drug safety crisis,''' Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, said today in a letter to acting FDA Commissioner Lester Crawford.
Grassley requested details of meetings with Canadian officials concerning Adderall and related records and documents. A phone message left after normal business hours for FDA spokesman Brad Stone for comment on Grassley's letter wasn't immediately returned.
(Doesn't it make you sick?) -This info is from a Bloomberg article.