2013-163
November 13, 2013
Diana Zlomislic's article "Risky acne drug Diane-35 underscores Health Canada's limitations" (Nov. 9, 2013) misleads readers and confuses several important points.
The Star misleads its readers by alluding that Canada is alone in allowing market access for Diane-35. The European Medicines Agency (EMA) came to the same conclusion that Health Canada did on Diane-35: the drug's benefits continue to outweigh the risks when used as authorized for the temporary treatment of severe acne in women who are unresponsive to other available treatments. It should not be used in patients with a history that puts them at risk for blood clots, and is not approved for use as an oral contraceptive. France is the only country that temporarily suspended the sale, but has reversed its decision subsequent to the EMA finding. We will continue to work to help ensure that women and health professionals are aware of the approved conditions of use.
Health Canada communicates risks and issues related to health products to the public immediately, by sending out notices through a number of different channels. As the Toronto Star knows, drug manufacturers are required to communicate problems with their drugs to Canadians; if they do not, Health Canada will take action.
Everyone has a role to play when it comes to drug safety.
As mentioned to the Star several times, the Government of Canada clearly stated that it will introduce new patient safety legislation. This will include new powers to require reporting of adverse drug reactions. As committed in the recent Speech from the Throne, the new patient safety legislation that will also ensure the quick recall of unsafe drugs.
Finally, the Minister recently asked the Department to take the steps necessary to begin publishing drug safety reviews transparently so that Canadians and medical professionals have the information they need and want. Health Canada is moving forward and working towards posting this information.
Scott Sawler
Director General, Marketed Health Products Directorate
Health Canada
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