New cancer-causing toxin found in recalled blood pressure pills

A photo illustration shows a stethoscope and blood-pressure machine.
A photo illustration shows a stethoscope and blood-pressure machine.PHOTO: REUTERS

NEW YORK (REUTERS) - US health regulators said on Friday (March 1) a third cancer-causing toxin was found in some blood pressure pills recalled by India's Hetero Labs a day earlier, adding to a global recall of commonly used drugs to treat hypertension.

The US Food and Drug Administration is also looking into whether these types of impurities could be found in other classes of drugs, a spokeswoman for the regulator said.

The latest toxin, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), identified in 87 lots of Hetero's losartan potassium pills, was not found in medicines that were previously recalled by a number of drugmakers.

Global authorities have been clamping down on sales of some blood pressure medicines as they are suspected to be tainted with two probable carcinogens - N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA).

The drugs, including losartan, belong to a class of widely used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs.

Some generic versions of other ARBs, such as valsartan and irbesartan, have also been recalled.

The FDA said increased risk of cancer to patients exposed to the new impurity NMBA appeared to be the same as those exposed to NDMA, but less than the risk from NDEA.

The recalls began last year after European regulators said ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals to produce valsartan contained cancer-causing impurities.

Since then, generic drugmakers such as Mylan NV, Teva Pharmaceutical and Novartis' Sandoz have recalled products containing the tainted ingredients.

In January, the FDA had warned of the possibility of additional shortages of hypertension drugs in the United States due to the recalls.

The FDA also said it is working to develop testing methods to detect other cancer-causing impurities.

In Singapore, the Health Sciences Authority (HSA) said in December that it has been testing the ARBs marketed in Singapore for the presence of NDMA and NDEA.

"To-date, none of the marketed ARBs that were tested by HSA has been detected to contain unacceptable levels of NDMA or NDEA. Hence, Singapore is not affected by the product recalls overseas," it said on Dec 19, 2018.

"While the ARB medicines that are available in Singapore are not affected, HSA will continue to monitor the local situation and update the public if there are any new findings," it added.

The HSA also said that patients should continue to take their ARB medicines unless otherwise advised by their doctors.