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.. Look what Russell Katz, MD, director of the FDA’s neurological drugs office said..
“One child was in a boot camp and exercising in 110 degrees,” Katz says. “Two others had high blood levels of the drug, possibly reflecting an overdose. They way we try to assess causality — to ask, ‘Did the drug do this?’ — it is hard to answer that by looking at an individual case. Just because a child died while on Adderall doesn’t mean the drug was the cause. It could have been 50 different causes. So we look at how many deaths there were in kids exposed to Adderall, and compare that to the background rate in the population. We don’t really believe this is different than background rate, although we have no good data on the actual background rate of sudden death in all kids — or in kids with ADHD, who may have a higher background rate.”
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.