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Medical Forum / General / Cardiology / January 2006Statin Drug Labels must carry WARNING in Canada
Another example of how drugs are different between Canada and the US. In Canada the labels warn the patients of dangers. http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_T ype1&c=Article&cid=1137107416336&call_pageid=968332188492&col=968793972154&t=TS_ Home Per an article in today's Toronto Star: Statin drugs must carry health warning Jan. 13, 2006. 03:33 AM ELAINE CAREY MEDICAL REPORTER Excerpts: "Statins, the popular cholesterol-lowering drugs used by more than 3 million Canadians every day, can lead to serious muscle damage in some patients, Health Canada is now warning." "The makers of all the drugs, which include Lipitor, Zocor, Pravachol, Mevacor and Crestor, must include a warning and description of the risk in patient safety-information sheets, the department said yesterday." "An analysis of the Canadian adverse drug-reaction database shows a statin was suspected as the cause of 1,739 adverse event reports filed between 1988 and 2003. Of those, 1,024 were considered serious." The PI sheet is not a label. In the US they also warn of risks. Bill > Another example of how drugs are different between Canada and the US. In > Canada the labels warn the patients of dangers. [quoted text clipped - 21 lines] > was suspected as the cause of 1,739 adverse event reports filed between 1988 > and 2003. Of those, 1,024 were considered serious." > Another example of how drugs are different between Canada and the US. In > Canada the labels warn the patients of dangers. > http://www.thestar.com/NASApp/cs/ContentServer?pagename=thestar/Layout/Article_T ype1&c=Article&cid=1137107416336&call_pageid=968332188492&col=968793972154&t=TS_ Home This link produces the following message for me: Invalid asset ID! Can not load an asset of type Article with ID '1137107416336'. Please supply a valid asset ID and try again. Please learn to use google. Also, please understand that the Toronto Star is free to make available its articles for only as long as it determines per it's corporate decisionmakers. Often the availability of news articles is 1 day, so use the cache option on your favorite search engine. >> Another example of how drugs are different between Canada and the US. In >> Canada the labels warn the patients of dangers. [quoted text clipped - 5 lines] > Can not load an asset of type Article with ID '1137107416336'. Please > supply a valid asset ID and try again. > Please learn to use google. It's wonderful how you some people accept criticism. You posted an invalid link. If you want people to use google, you should form your links in this manner: http://news.google.com/news?q=statins+canada+warning You're welcome. Google offers alerts - anyone can request them. For this particular link, which came to me as a response to a longstanding Google alert, you should have done a search on the exact title of the article. Again, if the link has been expired by the provider, you will need to view the cached version. >> Please learn to use google. > [quoted text clipped - 8 lines] > > You're welcome. >Another example of how drugs are different between Canada and the US. In >Canada the labels warn the patients of dangers. [quoted text clipped - 21 lines] >was suspected as the cause of 1,739 adverse event reports filed between 1988 >and 2003. Of those, 1,024 were considered serious." Using the data in this article, statins have been the cause of 1739 AE's in 45 million person-years, or 1 AE per 25,876 person-years. I'm sure that WAY underestimates the actual number of statin-related AEs (since most go un-reported), but it certainly makes this article a bit lame in my opinion. The addition of a safety warning in the Canadian PI (if that is what they are referring to) makes Canada and the US more alike, actually. I may be misunderstanding what is meant by "patient safety info sheet"- perhaps in Canada statin scripts come with a specific patient info sheet, like what is supposed to happen with Amiodorone or dofetilide in the US. |
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