Adderall Sales Suspended by Health Canada
US FDA Evaluating Data
In February 2005, Health Canada suspended sales of the once-daily formulation of the attention-deficit disorder drug Adderall, citing a risk that it may cause sudden deaths. Adderall is one of the most popular drugs for people with the widely-diagnosed condition more formally known as attention deficit hyperactivity disorder (ADHD).
The move by Canada puts pressure on U.S. regulators who have faced recent criticism for their handling of drug-safety matters. A senior Food and Drug Administration official said the agency has examined the same data as the Canadian regulators, but "we do not believe it is strong enough at the moment to merit an immediate change to the labeling or marketing status here in the United States."
In a one-page letter to the Shire Pharmaceuticals, Health Canada, said the "identified risk of sudden death following the recommended doses cannot be managed by label changes." There have been 20 reports of sudden deaths on Adderall's extended release and a prior formulation of the medicine since 1994, when the drug first came on the market. Shire Chief Executive Matthew Emmens said the company strongly disagrees with Health Canada's decision, which came as "an absolute complete surprise." Shire apparently received a call from a Health Canada official late in the day seeking voluntary withdrawal of the drug. He said he refused to pull the drug from the market and Health Canada responded by suspending it indefinitely.
Mr. Emmens said Shire intends to continue to sell the drug in the U.S. and that after the US FDA reviewed the same data earlier in 2004, the company was asked to add a third sentence to the existing black box warning saying that misuse of the drug "may cause sudden death and serious cardiovascular adverse events."
Of the 20 deaths reported in patients taking Adderall, 12 were from strokes, two in children, Health Canada said. The warnings about Adderall also will draw attention to the question of the safety of competing drugs such as Novartis AG's Ritalin and its generic equivalent, methylphenidate, Johnson & Johnson's Concerta, and Eli Lilly & Co.'s Strattera, which isn't a stimuland but which has potentially been linked to serious liver side effects.
The Canadian decision is likely to create a headache for the FDA, which already is under scrutiny because of questions from Congress about whether the agency reacts aggressively enough to drug safety issues. Concerns emerged last year during congressional investigations of the FDA's response to worries about the potential risks of antidepressants, when regulators in the U.K. released stronger warnings about the drugs well before the FDA took a similar action and Merck & Co.'s withdrawal of Vioxx from the market because of evidence it was linked to increased rates of heart attacks and stroke.
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