Adderall Ordered Off Market by Canada; FDA Will Take Closer Look

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Deaths in U.S. from hyperactivity drug cause action

Feb. 10, 2005 – Health Canada has ordered ADDERALL XR to be taken off the market in that country, primarily because of deaths that occurred in the U.S., but the FDA has decided not to take any action at this time. The AP, however, quotes an FDA officials as saying people with heart problems should not take the hyperactivity drug.

In a statement yesterday, the FDA said the agency “is aware of Health Canada’s decision to suspend sales, but not revoke the approval in Canada, of the drug Adderall as a treatment for Attention Deficit and Hyperactivity Disorder (ADHD).”

They went on to say, “FDA has been in close consultation with the Canadian authorities regarding the basis for their action. FDA does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug based upon its preliminary understanding of Health Canada’s analyses of adverse event reports and FDA’s own knowledge and assessment of the reports received by the agency.”

Health Canada has suspended the market authorization of the product due to safety information concerning the association of “sudden deaths, heart-related deaths, and strokes in children and adults taking usual recommended doses of ADDERALL® and ADDERALL XR®.” The immediate release form of ADDERALL® has never been marketed in Canada.

Health Canada's decision comes as a result of a “thorough review” of safety information provided by the manufacturer, which indicated there were 20 international reports of sudden death in patients taking either ADDERALL® (sold in the United States, not in Canada) or ADDERALL XR® (sold in Canada). These deaths were not associated with overdose, misuse or abuse. Fourteen deaths occurred in children, and six deaths in adults. There were 12 reports of stroke, two of which occurred in children. None of the reported deaths or strokes occurred in Canada.

Health Canada is advising patients who are currently being treated with ADDERALL XR® to consult their physician immediately about use of the drug and selecting treatment alternatives.

The FDA is issuing a Public Health Advisory and information sheets on its website at www.fda.gov http://www.fda.gov in order to address questions that may arise from the Canadian announcement and to provide up-to-date information about Adderall’s safety profile.

Patients using Adderall (or parents of children on the drug) who have questions about this medication should consult their physicians before making any alterations to their therapy, the agency said.

“As with any drug, FDA will continue to carefully assess any new data that emerges which significantly affects the safety profile of this drug and will take immediate, appropriate action to promote the public health and make the public aware of its findings,” according to the FDA statement.