FDA recalling some valsartan medicines

Carcinogenic impurity found in heart medication.

The U.S. Food and Drug Administration issued a voluntary recall of several medications that contain the active ingredient valsartan, which is used to treat high blood pressure and heart failure.

“This recall is due to an impurity, N-nitrosodime- thylamine (NDMA), which was found in the recalled products, the FDA said in a statement. “However, not all products containing valsartan are being recalled.”

Officials say NDMA is clas- sified as a probable human carcinogen — a substance that could cause cancer. They said that finding findings are based on results from recent laboratory tests.

The FDA said the carcinogen’s presence is “thought to be related to changes in the way the active substance was manufactured.”

“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,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Patients already taking the recalled medications should contact their phar- macist or doctor immedi- ately, the FDA says.

To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

The specific medicines recalled are:

■ Valsartan, Major Phar- maceuticals.

■ Valsartan, Solco Healthcare.

■ Valsartan, Teva Phar- maceuticals Industries Ltd.

■ Valsartan/Hydrochlorothiazide (HCTZ), Solco Healthcare.

■ Valsartan/Hydrochlorothiazide (HCTZ), Teva Phar- maceuticals Industries Ltd.

NDMA is a chemical used to make rocket fuel, soften- ers and lubricants, among other products, according to CNN.

It can be unintentionally produced through certain chemical reactions and is a byproduct of some manufacturing processes.

Animal studies have found the substance can cause tumors in the liver, kidney and respiratory tract, CNN said.

Along with the FDA, 22 other countries previously announced recalls of med- ications containing valsar- tan, according to CNN.

The FDA said its continuing to investigate the matter and will provide more infor- mation when it is available.