A common blood pressure and heart drug manufactured in bulk by a Chinese company and sold worldwide may have contained an impurity linked to cancer since 2012, European regulators said on Tuesday. If you are unable to find that information on the label, contact the pharmacy where you purchased your medication.
A request for a class-action suit filed in the Montreal courthouse on Monday wants the manufacturers of a recalled heart medication, valsartan, to pay damages to Quebecers who took the drug.
Huahai customer Harbin Medisan Pharmaceuticals has also recalled valsartan dispersible tablets made using Huaihai ingredients.
The US Food and Drug Administration (FDA) issued a similar notice about a week later.
It is classified by the United States Environmental Protection Agency as a probable human carcinogen.
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The class-action request is being made on behalf of anyone who bought or ingested the recalled valsartan products.
A FDA spokesperson told Fortune that specific information including returns and dates of the impacted medication will be provided by the pharmaceutical companies and posted to the FDA's website. Patients who are on valsartan should continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.
The FDA said because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled medicine should continue taking it until they have a replacement. The FDA believes the sudden presence of NDMA is due to how the substance was manufactured. The medicines which were said to contain N-nitrosodimethyamine as it is suspected to contain human carcinogen.
In his statement, FDA Commissioner Dr. Scott Gottlieb said his "drug shortages team is also working hard to ensure patients' therapeutic needs are met in the United States with an adequate supply of unaffected medications". It is an industrial by-product or waste product of several industrial processes, such as treatment of water via chlorination for use in manufacturing various products including processed foods and medicines. This is raising concerns among the people about what medications can be used without causing further deterioration to the patients. According to Harry Lever, a cardiologist at the Cleveland Clinic, "It's not just valsartan".
Overall, more than two-thirds of all active drug ingredients originate in China and India, industry experts estimate, with China accounting for the lion's share.