For the second time in as many weeks, the Food and Drug Administration has notified physicians and patients that yet another sartan drug used to treat hypertension has been contaminated with a carcinogenic industrial chemical. The manufacturer of the drug has issued a voluntary recall for a single lot of the medication losartan (potassium hydrochlorothiazide), identified as JB8912.
This recall comes in the wake of similar actions involving two other medications in the same class. In July, several batches of the drug valsartan were discovered to contain n-nitrosodiethylamine, or NDEA. This chemical is used in the processing of jet fuel, gasoline, and oil-based lubricants.
At the end of October, a similar discovery was made in batches of irbesartan. These drugs belong to a class of blood pressure medications known as angiotensin II receptor blockers, or ARBs. All three of the medications in question contain an ingredient manufactured in China by the Zhejiang Huahai Pharmaceutical Company Co. Ltd., where the contamination occurred.
In September, the Chinese pharmaceutical firm was put under an import alert by the FDA after inspecting its manufacturing facilities. As a result, none of its products are allowed to come into the US. Currently, the FDA is testing all sartan drugs for the presence of NDEA.
Although NDEA is considered to be a human carcinogen by the EPA, there is uncertainty about the actual risk of developing cancer from taking the tainted medication. Some sources suggest the chances are quite low. An FDA estimate indicates that if 8,000 patients took the maximum dose of contaminated valsartan daily over a four-year period, it may result in one additional case of cancer over their lifetimes. Most patients do not take the maximum dose, however.
Specific sartan medications that have been affected by these recalls include Avapro, Aprovel, and Karvea (irbesartan), products of SciGen Pharmaceuticals; valsartan drugs from Teva Pharmaceuticals and its subsidiary, Actavis Generics; and Cozaar, the brand name for losartan, sold and marketed by Sandoz. More extensive information on testing and affected products is available from the FDA website.
If you are currently taking one of the prescription sartan medications in question for managing high blood pressure, it is not advisable to simply stop it without consulting a physician. If you have concerns about sartan contamination, they may be able to switch you to a different brand or similar drug to replace your current prescription with a different anti-hypertensive.