The millions of Canadians who depend on a common heart medication are asked to check with their pharmacist after Health Canada announces that the drug may be contaminated by a carcinogen.
Health Canada said on Tuesday that numerous varieties of valsartan, a generic drug sold by several companies in Canada, are being recalled for fear they are contaminated with N-Nitrosodimethylamine (NDMA), a chemical that has been clbadified as probable human carcinogen by the International Agency for Research on Cancer. In a public notice, Health Canada said that the Chinese company Zhejiang Huahai Pharmaceuticals supplied valsartan to several companies that used it to manufacture the finished product.
Health Canada learned of the problem on June 27, but had to contact drug manufacturers and determine the extent of the problem before issuing a public notice, a spokesman said Tuesday.
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Valsartan is used primarily to treat high blood pressure, heart failure or for patients who have recently had a heart attack. There were more than 2.5 million prescriptions for the drugs involved in the recall in Canada last year, according to IQVIA, a company that tracks the pharmaceutical industry. That represents more than half of the total 4.4 million prescriptions dispensed for Valsartan in Canada, according to IQVIA data.
The European Medicines Agency made a similar announcement last week. According to an EMA press release, the presence of NDMA "is believed to be related to changes in the way the active substance was manufactured."
It is not clear if the withdrawal will result in a shortage of valsartan. There are companies in Canada that produce valsartan unaffected by the recall, but a large part of the drug supply was affected by the news, said Iris Krawchenko, senior pharmaceutical advisor to the Canadian Association of Pharmacists.
The shortage of medication has become an overly familiar occurrence in Canada in recent years, he said, posing challenges to pharmacists and patients who need access to proper medication.
"This is an unfortunate memory that can affect many patients in Canada," said Ms. Krawchenko. "Unfortunately and unfortunately, pharmacists deal with these kinds of shortages and remember too often."
A June report from C.D. The Howe Institute discovered that approximately one in ten medicines has been affected by shortages in recent years. Pharmaceutical companies often cite problems with raw ingredients as the reason for the shortage.
Jacalyn Duffin, one of the authors of the report and a professor at Queen's University, said that Canadians know very little about where the ingredients of the drugs come from and do not get enough advance warning about the pending shortage.
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"We continue to be surprised by products that disappear for one reason or another," he said. "We are always struggling to try to find substitutes for them."
Health Canada advises Canadians taking any valsartan medication to contact their pharmacist and healthcare provider to determine what steps to take.
of all drugs contained in the recall, see the recall and safety alert website.