Medication Recall Against Hypertension Increases With Cancer Risk

The FDA has announced that Teva Pharmaceuticals USA is extending its voluntary recall of drugs for the treatment of high blood pressure, losartan potbadium. The recall began on April 25 in the United States and was extended to six other batches of bulk losartan potbadium USP tablets. The booster is due to an impurity that can cause cancer in some hypertensive patients.

The problem

The recall, announced for the first time on April 25, involved losartan potbadium tablets at 25 mg and 100 mg – they were provided exclusively to Golden State Medical Supply for a volume of 35 bulk lots. The reason for the voluntary booster was the detection of an impurity called NMBA, which was detected in half a dozen batches of active pharmaceutical ingredient (API) manufactured by Hetero Labs.

According to Teva Pharmaceuticals, the NMBA impurity was detected at concentrations above 9.82 ppm, which corresponds to the FDA's provisional acceptable exposure limit. In case of high consumption for a long time, the NMBA can cause the development of cancer in "few patients".

Extended reminder

In a statement released this week, the FDA revealed that Teva was expanding the recall to six other bulk batches of losartan potbadium tablets USP, two to 50 mg and the other four to 100 mg. The six lots contained the same NMBA impurity.

As with the initial recall, these newly recalled bulk recalled lots were sold to Golden State Medical Supply in California, which packs the tablets under its own label in bottles ranging from 30 to 1,000 tablets. The FDA describes the 50 mg tablets as oval and green with the LK 50 stamped on one side and the ">" on the other. The 100 mg tablets are dark green and contain LK 100 instead of LK 50.

What to do if you have recalled tablets

Do not stop taking the tablets, warns the FDA, even if they are concerned with this booster. The reason is due to the risks of uncontrolled hypertension, which exceeds the known risk of taking tablets containing this impurity. Patients are advised to inform their health care provider or pharmacist to determine what action to take.