Drug recall for hypertension increases again due to cancer concerns

The US Food and Drug Administration said another heart medication had been voluntarily recalled after tests had shown that it was contaminated with a potentially carcinogenic chemical.

The new hydrochlorothiazide booster of losartan potassium is sold by the company Sandoz. Voluntary Recall is for 100 milligram / 25 milligram tablets only. It does not apply to other versions of the drug, sometimes sold under the brand name Hyzaar. If you are taking Sandoz losartan potassium, look for the lot number on the bottle. If it has lot number JB8912, then you have the recalled pills. Patients use these drugs to control their hypertension.

The drug is recalled because the active ingredient has been tested positive for N-Nitrosodiethylamine or NDEA, a suspected carcinogen for both humans and animals, used in gasoline as stabilizer for industrial products and as a lubricant additive, according to the National Institutes of Health.

The ingredient was manufactured by Zhejiang Huahai Pharmaceutical Company Co. Ltd. The FDA has put the Chinese company on alert at the end of September, which means that all of its active pharmaceutical products and finished products will not be allowed to enter the United States. The FDA made this decision after an inspection of the facility.

Several pills containing valsartan, another drug used by cardiac patients, have been recalled since July. The drugs were contaminated with NDEA or NDMA, N-nitrosodimethylamine, an impurity that is also considered a possible carcinogen by the US Environmental Protection Agency.

NDMA is an organic chemical used in the manufacture of liquid rocket fuel. It comes from the manufacture of certain pesticides and the processing of fish. It can be introduced unintentionally into the manufacture through certain chemical reactions.

The FDA is testing all the heart medications called ARAs to detect these impurities.

All medicines containing valsartan are not recalled. The FDA maintains a list of recalled products and a list of non-recalled valsartan products.

According to the FDA, the latest recall concerns less than 1% of the total pharmaceutical products containing losartan in the US market.

If your medicine is on the recall list, the FDA suggests taking it until your doctor or pharmacist replaces it. As all drugs based on valsartan and irbesartan are not affected by the recall, you may be able to upgrade to a version offered by another company.

It is not clear what the risk of cancer is if you take Valsartan tablets; the FDA felt that the risk was low with the recall of valsartan.

He estimated that if 8,000 people took the highest dose of valsartan (320 milligrams) containing NDMA in these recalled batches for four years, there could be a new cancer case in the lifetime of 8,000 people . Many patients take a much lower dose of valsartan and, as a result, their risks are theoretically much lower.

The FDA has announced that it will continue testing all products containing valsartan and similar drugs for the presence of impurities.

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