New
cancer-causing toxin found in recalled blood pressure pills
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.
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