A valsartan medication recall has been expanded due to concerns that a cancer-causing contaminant reached multiple batches of the blood pressure medication.
Late last month, Health Canada requested that Teva Canada, a drug company that produces valsartan, expand a voluntary valsartan medication recall of the drug to eight more batches of the drug, beyond the original 28 recalled batches.
The contaminant in question is N-nitrosodimethylamine, or NDMA. This chemical can increase a risk of cancer in humans, and has been linked to liver damage. The contaminant was found to have been introduced into the drug in its manufacturing plant in China, owned by Zhejiang Huahai Pharmaceuticals.
A Health Canada spokeswoman told CTV News the agency requested that the recall be expanded because “there are different products that have valsartan in it. In the initial recall there was an impurity found in the valsartan used in these products.”
Health Canada addressed both patients and pharmacists in context with the recall, urging pharmacists to check their inventory for recalled medications. However, the agency urged patients taking valsartan to consult their physicians about their treatment options, and to not stop taking the medication without first consulting their physicians.
Phil Emberley, a practicing pharmacist, said to CTV News, “Don’t stop taking your [blood pressure] medication without consulting first, because your blood pressure could go up and that could cause a whole host of problems … blood pressure can lead to a stroke or heart attack.”
He went on to tell patients that there are other options for patients taking valsartan, saying that there are similar medications that do the same thing that have not been exposed to NDMA.
In the United States, concern has also been raised about valsartan and the fact that it had been reportedly contaminated with a possible carcinogen.
In July 2018, valsartan was recalled by the FDA over concerns that the drug had been contaminated with a cancer-causing chemical during the manufacturing process.
According to the FDA-issued valsartan medication recall, “the presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.”
Patients should note that not all valsartan products have been recalled, but 28 valsartan products were subject to recall, including those produced by the following manufacturers and repackagers:
- Major Pharmaceuticals
- Solco Healthcare
- Teva Pharmaceuticals
- Bryant Ranch Prepack
- J Harkins Company
- Lake Erie Medical (d/b/a Quality Care Products)
- NuCare Pharmaceuticals
- Northwind Pharmaceuticals
- Proficient Rx
Like Health Canada, the FDA announced in August that it would expand its recall of the drug as information became available about the true extent of the contamination, and is investigating the impact of the valsartan contamination on human health.
Both Health Canada and the FDA have announced that they are testing valsartan for the presence of NDMA.
Health Canada is specifically reviewing long-term health impacts of NDMA, and hoping to learn how much NDMA patients may have been exposed to as a result of the valsartan contamination. Health Canada says they expect to have further information available in the coming weeks.
If you developed cancer or severe liver damage after taking valsartan, you may benefit from joining a free valsartan lawsuit investigation. Fill out the FREE form on this page for more information.
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