A recall of high blood pressure prescription medications has been expanded for the fifth time due to the risk of higher than acceptable amounts of a potentially cancer-causing compound, NDMA. The newest recall is targeting three additional lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide tablets by Torrent Pharmaceuticals Limited. The recall affects Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets.
Losartan is a drug used to treat hypertension (high blood pressure), hypertensive patients with Left Ventricular Hypertrophy, and for the treatment of nephropathy in Type 2 diabetic patients. In Losartan Potassium and Hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.
Patients who are currently taking these medications are instructed to continue to take them if stopping the use or switching to a different medication could cause issues. They are also being advised to discuss the recall with their physician. The risk for continuing to take the medication is not fully understood at this time, but it is believed to be "low," according to the FDA.
NDMA has been classified a semivolatile organic chemical by the Environmental Protection Agency. It is formed through both industrial and natural processes. The substance is classified as a B2 carcinogen (probable human carcinogen). Symptoms of overexposure include headache, fever, nausea, jaundice, vomiting, abdominal cramps, enlarged liver, reduced functioning of the liver, kidney, and lungs, and dizziness. NDMA is listed as a priority toxic pollutant in the Code of Federal Regulations.
We recently covered a similar recall involving NDMA. Makers of the popular over-the-counter medication Zantac were sued by a group of plaintiffs in California earlier this month. This group had all taken the drug for a significant period of time, to treat long-term peptic ulcers. They claim that the amount of NDMA in the recommended dose for peptic ulcer disease far surpassed the standard acceptable threshold of daily NDMA intake, set by the US Food and Drug Administration. This week, drug stores across the country have pulled Zantac from their shelves over concerns about the potential cancer risk.
The FDA has begun testing all drugs called "angiotensin II receptor blockers" for these impurities. Also known as ARBs, they block a potent chemical in the blood called angiotensin that causes muscles surrounding blood vessels to contract. When the chemical binds, it narrows the vessels, and that can cause high blood pressure.
If you think you may have tablets from the recalled lot, or you are interested in further information about the recall, visit the FDA's recall page.