The Medicines and Healthcare products Regulatory Agency has advised patients to continue taking diabetes medicine, metformin, despite reports of a possible N-nitrosodimethylamine (NDMA) contamination.
The government agency said it was aware that the impurity had been found in some metformin medicines outside the UK, but it maintained that the risk from not having adequate diabetes treatment far outweighed any possible effects of the low amounts of NDMA.
MHRA said the levels of NDMA seen in the affected non-UK metformin medicines were very low. They “appear to be within or even below” the range that people would normally be exposed from other sources such as food and water.
Since last week, the US Food and Drug Administration has been investigating a range of drugs, including metformin, for the presence of carcinogen after heartburn drug Zantac was recalled this year for fear it contained NDMA.
The FDA later added that levels of contamination in Zantac, also known as ranitidine, “are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.”
European Union drugs watchdog EMA said it was asking companies to test metformin medicines in the EU for NDMA, reacting to findings in Singapore of NDMA impurity in some metformin products.
EMA said Singapore’s Health Sciences Authority (HSA) was recalling three out of the 46 metformin products tested.
EMA described the risk so far as very low, urging patients to continue taking their medication because the danger of not adequately controlling diabetes was far higher.
MHRA said it was working closely with EMA and other regulatory authorities to determine whether any further action was required.
Metformin is a standard medication during the early stages of type 2 diabetes.
It helps control high blood sugar and is marketed under a number of brand names including Fortamet and Glucophage.
(With inputs from Reuters)