FDA recalls blood pressure medications after cancer-causing agents found

Leslie Hanson
July 17, 2018

The U.S. Food and Drug Administration (FDA) has announced a voluntary recall of several blood pressure medications that may contain an impurity known as N-nitrosodimethylamine (NDMA), a probable human carcinogen (a substance that could cause cancer).

The EMA said NDMA was an unexpected impurity that was not detected by routine tests carried out by Zhejiang Huahai, adding that the manufacturing changes introduced in 2012 were believed to have produced NDMA as a by-product.

The medication containing valsartan that Denise Meade is now has is not on this list, but she is still concerned she may have taken one of the recalled brands in the past.

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.

The agency advised patients taking the drug to look at the manufacturer's name on the label of their prescription bottle to determine if it is part of the recall.

Patients taking these prescriptions to treat serious medical conditions should keep taking them until they have a replacement product.

The case shows the reliance of consumers around the world on medicines containing active pharmaceutical ingredients made in China.

Huahai customer Harbin Medisan Pharmaceuticals has also recalled valsartan dispersible tablets made using Huaihai ingredients. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

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.

"We have carefully assessed the valsartan-containing medications sold in the United States, and we've found that the valsartan sold by these specific companies does not meet our safety standards".

If your medicine is listed in the recall, you should contact your pharmacy or doctor to discuss treatment. Solco Healthcare's information is already on the FDA's website, information from Major Pharmaceuticals can be found on its website, and early Monday evening Teva Pharmaceuticals USA released a statement with information about the recall.

Included in the announcement is Solco Healthcare LLC., which is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. "That is why we've asked these companies to take immediate action to protect patients".

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