Thousands of local patients affected by recall of contaminated heart drug






Windsor Regional Hospital’s Dr. Wassim Saad, shown in this May 9, 2015, file photo, said a heart drug for which Health Canada has issued a public warning is from a “very commonly prescribed class of medication.”


Jason Kryk / Windsor Star

Thousands of Essex County residents with heart conditions and high blood pressure have been taking medication that could contain a cancer-causing chemical.

Health Canada has announced that several medications with the ingredient valsartan are being recalled because it contains a “potential human carcinogen.” Millions of Canadians could be affected.

Tim Brady, who runs Brady’s Drug Store in Belle River and Essex, said this goes far beyond the average recall that pharmacists often deal with.

“This is a potential health harm,” said Brady, who spent the last couple days contacting patients taking the medication. “So it’s a little bit higher level than we usually deal with, for sure. I don’t recall seeing one of this magnitude since I’ve been practicing. It’s pretty widespread. It’s a well-known drug. It’s been around for a long time. It went generic a few years ago. It’s one of the bigger ones.”

Drugs containing valsartan are prescribed to people with high blood pressure to prevent heart attacks and stroke. The drugs are also given to patients who have had heart failure or a recent heart attack.

Health Canada said several drugs containing valsartan are being recalled because they are contaminated with N-nitrosodimethylamine, a chemical classified as a potential human carcinogen. With long-term exposure, it could cause cancer.

Using statistics from IQVIA, a company that tracks the pharmaceutical industry, the Globe and Mail reported that there were about 4.4 million prescriptions for valsartan drugs in Canada last year. More than 2.5 million of those prescriptions were for drugs involved in the recall.

Health Canada said the valsartan in question came from a Chinese firm called Zhejiang Huahai Pharmaceuticals, which is a supplier to several drug producers.

Health Canada learned there was a problem on June 27 when it was contacted by the maker of a valsartan product. But before going public, the health agency worked with that company and other manufacturers to determine the scope of the issue and the potential risks.

“Once Health Canada confirmed the risk and scope of the impacted products, the affected manufacturers were requested to recall products in order to mitigate the risk to health of Canadians,” Health Canada spokesperson Maryse Durette said in an email.

Health Canada announced the recall on Tuesday. A recall was issued in Europe last week.

“The real issue for this one is it’s such a broad recall,” said Brady. “Normally it would just be one brand. But in this case it’s global.”

Health Canada said it has not received “any adverse reaction reports related to cancer” involving medications listed in the advisory.

Wassim Saad, Windsor Regional Hospital’s chief of medicine, said that while there is a risk of getting cancer, it is relatively low.

“In some animal studies and some very small human studies it caused gastric cancer, so stomach cancer, and colorectal cancer,” said Saad. “But we’re talking months and sometimes years and oftentimes decades of exposure. So it’s unlikely that anybody is really going to see any harm from this.”

Durette said that after Health Canada distributed the recall information, the College of Physicians and Surgeons and College of Pharmacists are responsible for telling their members to contact patients.

Heather Foley, president of the Essex County Pharmacists Association, said her organization has not formally addressed the situation with members.

“Any pharmacist that knows they have a patient on the medication would be contacting that patient,” said Foley. “There are often shortages and recalls. So pharmacists are used to dealing with these types of things.”

Brady said there are likely at least a couple thousand people across Essex County who are on medication with valsartan. His pharmacy has compiled a list of customers who recently filled a prescription for one of the medications.

Saad agreed that a couple thousand people taking a drug with valsartan in Essex County is probably a “good estimate.”

“If you are looking at patients who have had a heart attack or a stroke, 100 per cent of them would be on a drug like valsartan, or in that family,” he said. “So whether their physician chose to use valsartan or another drug similar to it, it’s hard to know. But I can tell you it’s a very commonly prescribed class of medication.”

twilhelm@postmedia.com

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