The U.S. Food and Drug Administration often issues recall reports on drugs and treatments due to potential hazards. And as it turns out, the federal agency reported, a drug company just issued a recall for a popular brand of blood pressure medication.
Early on Monday, Macleods Pharmaceuticals Limited issued a recall impacting one lot of the blood pressure medication losartan. According to the company, recalled items contain trace amounts of N-nitrosodiethylamine, or NDEA, a probable carcinogen. The FDA shared the recall announcement on its website.
Impacted items include the 100 mg/25 mg losartan and potassium/hydrochlorothiazide tablets. According to many reports, despite the warning, physicians are advising patients to continue taking the medication until pharmacists are able to replace the drugs for items without the carcinogen. Due to the sensitive nature of the conditions many patients suffer, discontinuing the medication could cause immediate harm. The firm said that one of the main issues with these drugs is that they were produced at Hetero Labs Limited in India. The same facility associated with other blood medication recalls. And it’s precisely because of these problems that the U.S. House Committee on Energy and Commerce is asking the FDA about the safety of the medications produced in facilities overseas.
The blood pressure and heart medications associated with at least 15 other recalls recently include valsartan, losartan, and irbesartan. All items contained some traces of NDEA. These drugs work by relaxing the patient’s blood vessels and they are part of the angiotensin II receptor blocker class of medication.
Because of the high number of recalls involving blood pressure drugs, the FDA is under scrutiny.
After issuing an import alert to block Zhejiang Huahai Pharmaceutical-made drugs from entering the country, the agency is now downplaying the risks associated with the valsartan medications.
But despite their claims, the agency is now reviewing the committee’s letter so they better respond to Congressional staff. It also told reporters that it continues to increase its inspections of generic drug plants in foreign countries.