Auditor General Cites Topamax in Criticism of Health Canada’s Slow Warnings of Drug Risks

The Canadian Auditor General has stated that the federal health department is too slow at warning Canadians of the risks involved in taking various medications — both over-the-counter and prescription brands.

The report makes an effort to specifically point out everything that has happened with the prescription medication Topiramate (Topamax), which was determined by studies to cause birth defects in babies whose mothers took the drug while pregnant. Topamax is given as a treatment for epilepsy, migraine headaches and various different psychiatric conditions, and was linked to birth defects in 2009. The problem, according to the Auditor General, is that it took six months from being told about Topamax dangers in September 2009 for the manufacturers of the drug to update the labels. Then it took another 10 months for Health Canada to find out about it. Because of that extra 10 months, the auditors found that only 12 generic manufacturers of Topiramate had actually updated the monograph by this May.

That is a significant time lapse, and Interim Auditor General John Wiersema said, “It can take up to two years to review the safety issue and to communicate the results to Canadians. We think that is too long.”

While Wiersema is blaming this on a general lack of resources and too high a workload, he does say that he is hoping the situation will be cleared up by charging higher user fees for the pharmaceutical companies to get their products approved by Health Canada. A Health Canada audit, which was tabled to the House of Commons on November 22, found that the regulatory process that is supposed to keep people safe is actually “clouded by secrecy and long delays.” It also shows that while Health Canada reviews submissions quickly when it comes to approving them, it often fails to reach its own time standards when it comes to reviewing necessary label changes for drugs that are already approved.

This time frame is even longer for the drug makers, who often don’t communicate very well between departments. Topamax is only one drug that slipped through the cracks of disclosure, but the birth defects risks caused many babies to be born with health problems that they could have avoided had the mothers been properly warned. Some of those health risks include cleft palate, PPHN and neural tube defects.

If your child was born with birth defects, contact attorney Greg Jones today for a free consultation. Let me fight for you to get any money you may be entitled to for your baby’s injuries.

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