The United States Food and Drug Administration issued a voluntary recall on another blood pressure medication. The FDA cited possible contamination.
According to a USA Today report, the blood pressure drug losartan became the latest drug to face a recall due to contamination with a possible cancer-causing agent.
Sandoz Inc. voluntarily recalled losartan potassium hydrochlorothiazide tablets over fears that they may contain N-nitrosodiethylamine (NDEA). NDEA is listed as a possible carcinogen for humans and has led to recalls of the medications irbesartan and valsartan earlier this year.
So far, the latest hypertension drug recall only includes losartan 100 milligram/25 milligram tablets with a lot number of JB8912 that went into distribution on October 8 and later. Patients who have these pills should discuss the situation with their doctor or pharmacist before abruptly stopping them due to health complications. Consumers who have tablets outside of these doses and lot numbers are not included.
CNN reported that NDEA is a stabilizer used in the gasoline industry as a lubricant additive. Zhejiang Huahai Pharmaceutical Company Co. Ltd. manufactured the ingredient, and the company found its way onto an FDA import alert in late September after a facility inspection. Because of that alert, none of its products will be allowed to enter the United States.
Patients who are currently taking losartan potassium hydrochlorothiazide tablets are advised to speak with their doctor before stopping use, because the risk of going off of the medication might be greater than the possible cancer risk. https://t.co/vV4YtJi8Ob
— USA TODAY (@USATODAY) November 13, 2018
So far, the recalled blood pressure drugs from the past few months are linked to the facility and contain NDEA or NDMA, N-nitrosodimethylamine contaminants. NDMA is used in liquid rocket fuel, and it’s also manufacturing byproduct of some pesticides and fish processing. At this time, the FDA is testing every heart medication in the ARB classification for the contaminants, and that is leading to the drugs being called back from consumers’ homes or pharmacy shelves.
The good news for valsartan users is that this newest issue only affects fewer than 1 percent of patients who use the medication to help control hypertension in the United States. For now, the actual risk to patients who take or have taken the contaminated pills is unknown, but the FDA believes that the risk is low from the earlier drugs it recalled due to this potential cancer threat. The estimated increased risk for the valsartan recalled earlier this year is one in 8,000 patients who take the highest dose daily for four years, which won’t happen because of the steps taken by the FDA to ensure these pills are not available in the U.S.
For questions, consumers can contact Sandoz Inc. at 800-525-8747 or they can email email@example.com to receive answers.