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Friday, September 14, 2018 (HealthDay News) – There is more bad news for Americans who have taken some brands of the common drug for blood pressure, valsartan.
The US Food and Drug Administration warned Thursday that it had found a second impurity in three batches of valsartan-based medicines from Torrent Pharmaceuticals, used to treat hypertension and heart failure.
The FDA first recalled valsartan-based medicines in July, after China's Zhejiang Huahai Pharmaceuticals, which makes the drugs, found a contaminant called N-nitrosodimethylamine (NDMA) in several batches of its active ingredient, the valsartan API.
NDMA is a suspected carcinogen. However, people who had used the recalled Chinese-made product were reassured earlier this week. A study of more than 5,000 patients followed for nearly five years found that those taking the recalled valsartan were not more likely to develop cancer in the short term. The risk of cancer in the long term remains uncertain.
Now, in a statement released Thursday, the FDA has stated that Torsartan tablets at 160 milligrams (mg) (lot BV47D001) and 320 mg (lots BV48D001 and BV48D002) of Torrent were also contaminated with N-nitrosodiethylamine (NDEA) . NDEA is also classified as a possible carcinogen by the US Environmental Protection Agency.
The contamination by NDMA and NDEA could result from a specific sequence of manufacturing steps and chemical reactions, explained the FDA. After the detection of NDMA, the agency immediately conducted new tests on all valsartan products, including previously recalled drugs and other products sold in the United States, the agency said.
FDA tests show that all products made with Zhejiang Huahai Pharmaceuticals' valsartan API do not contain potentially dangerous impurities.
"As we continue to investigate the cause of impurities in products containing valsartan, our scientists are testing these products to better understand these impurities and to ensure that they are not present in any of these products. other products, "said FDA Commissioner Dr. Scott Gottlieb. in the press release.
He added that the FDA is also taking steps to prevent similar contaminations in the future and to provide the public with up-to-date information.
"We will also continue to work with global regulatory agencies to learn as much as possible about how these impurities have been detected and how they can affect the health of patients around the world," added Gottlieb.
The agency has created an ongoing list of affected products and encourages all patients taking a valsartan-based medication to regularly check the list to see if their treatment is affected.
If you notice that you are taking a medicine included in the recall, consult your doctor immediately, the FDA said. People using a recalled valsartan drug should not stop treatment until their doctor has prescribed another medication, the agency said.
More information
The US Food and Drug Administration has the latest information on valsartan recalls.
SOURCE: US Food and Drug Administration, press release, September 13, 2018
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