Another blood pressure medication is being voluntarily recalled after “tests showed that it was tainted with a potential cancer-causing chemical”.
A blood pressure drug losartan potassium hydrochlorothiazide made by Sandoz is being recalled after an active ingredient in the drug tested positive for N-Nitrosodiethylamine, a known human and animal carcinogen on California’s Prop 65 list of dangerous chemicals since 1987.
Along with its uses in gasoline production and as a lubricant additive. NDMA is also used to make rocket fuel, and is often found as a byproduct of manufacturing certain pesticides.
The chemical in the drug was made by Chinese drug company, Zhejiang Huahai Pharmaceutical Company Co. Ltd. This isn’t the company’s first taste of recall controversy, as this discovery comes after the FDA placed the company on an import alert in late September after an inspection of its facility. The import alert prevents any of the companies finished products or active pharmaceutical products from entering the United States.
The Losartan potassium hydroclorothiazide recall involves only tablets sold in 100 milligram/25 milligram tablets, and not other configurations of the drug, sometimes sold under the brand name Hyzaar. The recall can easily be distinguished by the drug’s lot number. The FDA suggests looking on the pill bottle for the lot number; if the lot number is JB8912 then it is the recalled pills.
This recall comes a few months after the recall of valsartan, another blood pressure medication often used by heart patients to keep high blood pressure in check. The recall, which occurred in July, came after the drug tested positive for NDEA or NDMA, N-Nitrosodiethylamine.
Due to these recalls, the FDA is testing related heart known as angiotensin II receptor blockers (ARBs) which lower certain chemicals that narrow blood vessels, alllowing blood to flow more easily
The latest recalls impact “less than %1 of the total losartan drug products”, according to the FDA, however, consumers should still approach related drugs with caution. And since there is a host of valsartan related drugs, many of which are not included in the recall, the FDA suggests that consumers try to switch to a version by another company.
According to tests done by the FDA on the carcinogenic dangers of the recalled medications, if an estimated 8,000 people took the highest dose of valsartan from the recalled batches (about 320 milligrams) containing NDMA daily for about four years, then there may be one additional case of cancer over the lifetimes of the 8,000 people who took the medication consistently. However, many consumers take a much lower dosage of the drug, thereby reducing their risk of cancer.
The FDA sees little risk of cancer-related illness in those who took the recalled drugs over an extended period time. Nevertheless, the administration will continue to test all related blood pressure medications, and warns consumers to immediately contact their doctor if the medication they take is suspected to be included in the recall.
Good idea. While the risk is low, that doesn’t matter if you develop a cancer from taking this medication.
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