Most of the people around the world are taking blood pressure medications. Blood pressure drugs are very common among the people taking it regularly for optimum blood pressure. The drug company Torrent pharmaceutical Ltd. has voluntarily recall blood pressure drugs. According to the FDA (Food and Drug Administration), the company has announced a recall of losartan-hydrochlorothiazide/potassium and losartan potassium tablets. The blood pressure drug recall is further expanded over the detection of cancer-causing nitrosamine impurity. The impurity called N-methylnitrosobutyric acid is found in some of the blood pressure medicines. According to Torrent Pharmaceutical Company, it is going to recall 36 additional lots.
No complaints of sickness due to the drug have been reported yet, but the level of impurity in these drugs is more than the FDA’s considerable intake daily. The US Food and Drug Administration has put a Chinese company on alert because it made a tainted ingredient that is the cause of recalls. The name of the Chinese company is Zhejiang Huahai pharmaceutical. The impurity that is harmful for human consumption is used as a lubricant additive or used as a stabilizer in gasoline. The recall of blood pressure drug is linked to valsartan recall; the recall is expanded repeatedly since July.
The Torrent Pharmaceutical Company has incorporated new testing methods associate to the recalls of the blood pressure drugs. Due to the detection of nitrosamines in the ingredients, there have been over forty recalls by overseas manufacturers and distributors in drugs called angiotensin II receptor blockers. This is also known as ARBs. The ARBs block a chemical that helps in the contraction of the muscles surrounding the blood vessels. The block of the potent chemical leads to high blood pressure. According to the FDA, the risk of taking these drugs with valsartan recall is lower.
Estimation by studying 8,000 people taking a higher dose of valsartan says, the people take the drug for four years that contains N-nitrosodimethylamine (NMBA), have a higher risk of cancer. On the other hand, people who intake a lower dose of the drug, have a low risk of cancer. FDA detects the unacceptable level of ARBs in the ingredients like valsartan, irbesartan or losartan in July. The NDMA and NDEA (Nitrosodiethylamine) are considered as a human carcinogen. The recalls by the Torrent pharmaceutical company make the FDA test all the drugs for blood pressure. FDA warns all the manufacturers of the blood pressure medications to maintain the acceptable level of ARBs in the drug.
FDA on its 19th April updates said that the new testing technique would help the international regulators and manufacturers to detect cancer causing impurities in blood pressure drugs. Even after the recall of medications, the FDA recommends the patients to consult with their doctors for alternative treatments. The doctors usually recommend losartan for people with type 2 diabetes and high blood pressure. The list of recalled blood pressure drugs is available at the website of the US Food and Drug Administration. FDA will continue to test the drugs for the level of impurities it has.