Is Valsartan Safe? FDA Recalls Heart Drug Over Cancer Concerns

The FDA has recalled a common heart medication after it was found to contain a potential carcinogen. Getty Images

The U.S. Food and Drug Administration has recalled a common drug used to treat heart conditions after it was found to contain a chemical linked to cancer. The U.S. decision came a week after 22 other countries had recalled the medication.

The FDA flagged concerns about valsartan, which is used to treat high blood pressure and heart failure, on July 13. Officials found traces of the chemical compound N-nitrosodimethylamine (NDMA) in the recalled products.

NDMA is a carcinogen, a substance that could cause cancer. The natural compound was formerly used to make liquid rocket fuel and antioxidants but is currently used only for research purposes.

Symptoms of exposure to NDMA at high levels can include headaches, fever, nausea, jaundice, vomiting, as well as reduced function of the kidneys, liver and lungs.

The FDA believes NDMA was found in valsartan because of changes in how the active substance was made. Not all products containing valsartan were recalled, however, the FDA said.

The agency has launched an investigation into the levels of NDMA in the recalled medications, which will include an assessment of the potential harm to patients who have taken the drug.

As medications that contain valsartan are often used to treat serious medical conditions, patients taking the recalled drugs should not stop until they have a replacement product, the FDA emphasized.

Patients worried about their mediation should contact the pharmacy that dispensed it.

Those who are taking the recalled medication should follow the instructions outlined by the company that manufactured the drug, the FDA said.

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Valsartan by Major Pharmaceuticals, Solco Healthcare, Teva Pharmaceuticals Industries Ltd, as well as Valsartan/Hydrochlorothiazide (HCTZ) by Solco Healthcare and Teva Pharmaceuticals Industries Ltd. were affected.

Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement: "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. This is why we've asked these companies to take immediate action to protect patients."

About 2,300 batches were involved in the earlier recall across Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta, CNN reported.