Canadian Drug Recalls Triple: Impact Unknown
Recalls and Warnings Triple from 2005-2013
We have all been reminded in recent days of the tragic and long-lasting consequences of dangerous medications. On Monday December 1, 2014, our House of Commons voted to offer “full support” to the survivors of the Thalidomide drug over 50 years after its horrifying effects were discovered. Thalidomide was marketed as a “safe day-time sedative” to treat pregnancy-related nausea. It was available in 46 countries for a short period of time in the late 1950’s and early 1960’s. In Canada, it was licenced for prescription use for less than a year between 1961 and 1962. The drug caused catastrophic birth defects in an estimated 12,000 babies around the world, with only 8,000 surviving to their first birthday. In Canada, there are 95 known Thalidomide survivors still living.
Less visible, but very concerning, is the issue of ordinarily safe drugs that reach the Canadian consumer in a defective form. In late September 2014, the Toronto Star revealed that it had obtained documents regarding U.S. Food and Drug Administration (FDA) inspections of facilities operated by Canadian drug manufacturers. According to an article in the Toronto Star, 40 Canadian drug companies had been cited by the FDA since 2008 for “serious manufacturing violations”. Some companies had even “hidden, altered and in some cases destroyed test data that showed their products were tainted or potentially unsafe”.
More recently, the National Post reported on a study that shows that the number of prescription drug recalls and warnings issued by Health Canada has more than tripled from 2005 to 2013. The study, published in London-based journal BMJ Open, showed an increase from 42 incidents in 2005 to 143 incidents in 2013.
The BMJ Open study raises numerous serious concerns. The largest, in our view, is the fact that adverse health events associated with the defective drugs are not reported by Health Canada or drug manufacturers. Further, the adverse reaction database does not provide the batch numbers of medicines linked with complaints about defective drugs. Accordingly, the researchers in the study could not compare the adverse drug reaction database with the expected risks associated with the recalled batches of defective drugs. As a result, there is no way of knowing what kind of health consequences, if any, have been suffered by Canadians as a result of the defective drugs reported by Health Canada.
Reason for Optimism
The cause of the threefold increase in defective drugs from 2005 to 2013 is not clear. However, there is some evidence that the increase reflects improved detection by Health Canada rather than an increase in defective medicines being given to Canadians. Our review of the study showed that the number of incidents of defective medicines was in consistent decline from 2005 (42) to 2007 (26), before Health Canada implemented a new Good Manufacturing Practices (GMP) inspection policy on January 31, 2008. The policy was introduced to ensure Canada’s compliance with international agreements. It was in 2008 that the trend reversed and the numbers of defective medicines increased each year to 2013.
If You Need Help
If you or someone you love has been harmed by a defective drug, you should consult an experienced personal injury lawyer immediately.
