Health Canada has allowed Shire BioChem, the makers of Adderall XR to resume sales of Adderall XR. Health Canada appointed an external and independent committee, the New Drug Committee (NDC), which concluded that Health Canada’s original actions in banning the drug were appropriate and that the drug should be reintroduced to the Canadian market once some conditions have been met, and Health Canada has approved all those conditions.
Primarily, when prescribing and patient information is revised to reinforce the safe use of this medication and to reflect safety concerns, including the risk of sudden cardiac death in the general pediatric population.
The committee also recommended that Shire BioChem Inc. distribute a letter to healthcare professionals to inform them about risks associated with use of the product. In addition, the committee recommended that the manufacturer support independent continuing medical education for Canadian physicians to reinforce their understanding of the issues around sudden/cardiac death in the pediatric population
Also, in line with the committee’s recommendations, Health Canada is committed to enhancing post-market surveillance of all stimulant drugs used in the management of Attention Deficit Hyperactivity Disorder. Specifically, Health Canada will request that Shire BioChem Inc. provide safety information to Health Canada on a regular basis.
Adderall XR sales in Canada were suspended on
February 9, 2005 due to safety information concerning possible sudden deaths, heart-related deaths, and strokes in children and adults taking regular recommended doses of Adderall® and Adderall XR®
But..
The U.S. Food and Drug Administration reviewed the data on the cases last summer and concluded the rate of sudden deaths and strokes in Adderall users wasn’t higher than what’s called the background rate — the rate of such events that would be expected to occur in people not taking the drug.
So if people were less likely to have sudden death taking the drug than not taking, why take it off the market? I talked to some people I know in Canada who are experts in ADD medication, and they said they weren’t consulted before Health Canada took it off the market and that it shouldn’t have been pulled. The data they made the decision was from the US and the US FDA didn’t pull it off the shelves, they just put on a warning label.
If a medication is a real danger to people then by all means take whatever means necessary to protect the public including banning it if necessary. But if it’s not dangerous, don’t act like it is.
The NDC’s recommendations will be available on the Health Canada website in the coming days. Might be worth a look.
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