In just over two weeks, this is the fourth time a recall alert has been made for blood pressure medication that could increase the risk of cancer on using it for a longer duration.
Vivimed has recalled 19 lots of losartan potassium pills because they have been found to be tainted with N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
The Indian-based pharmaceutical company said the impurity is above the FDA’s acceptable exposure limit.
The recall states, “Based on the available information, the risk of developing cancer in a few patients following long-term use of the product containing high levels of the impurity NMBA cannot be ruled out.”
Vivimed said the blood pressure medications were made at its facility in India. The pharma company said neither it nor its distributor Heritage Pharmaceuticals has received any reports of side effects or adverse events related to the recall.
The FDA in its statement said, “The risk of developing cancer by taking these recalled medications is extremely low, but the risk is still there.”
Last month, the director of the FDA’s Center for Drug Evaluation and Research Janet Woodcock said, “The FDA calculated that if you took the very highest dose of one of the affected medicines over four years, and you took the medicine that was the most contaminated, the risk is an additional one case in 8,000 people.” However, the FDA, as well as the pharma companies, said that you should continue taking your blood pressure medication until your doctor tells you about alternatives. Stopping the treatment completely could increase the risk of stroke or heart attack.
