The diabetes management drug Metformin, that is consumed by millions of South Africans could be contaminated with a chemical linked to cancer, health officials fear.
The diabetes drug marketed under the trade name Glucophage among others, is the first-line medication for the treatment of type 2 diabetes.
Now,the South African Health Products Regulatory Authority (SAHPRA) has released a statement following news relating to the contamination of NDMA which is is classified as a probable human carcinogen.
SAHPRA is investigating whether metformin-containing products in the South African market contain NDMA and whether the level is above the acceptable daily intake limit. To this end SAHPRA is working alongside companies and will take action where necessary.
Heartburn remedy, Zantac, was also found to contain the chemical in both UK and US supplies and this led to a recall globally.
The high 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.”
American, Asian and EU authorities testing underway
Metformin supplies in Singapore have been recalled after authorities found they contained small amounts of a chemical called NDMA. Soon after EU authorities notified Indian pharmaceutical company Granules, testing has been undertaken. Granules India has concluded that there is no possibility of the presence of NDMA in its product.
The European Union drugs watchdog, EMA said it was informing companies to start immediate tests on metformin medicines for traces of NDMA. This was after Singapore’s Health Sciences Authority (HSA) recalled three out of the 46 metformin products tested.
The UK’s Medicine and Healthcare product Regulatory Agency (MHRA) is considering whether similar action needs to be taken for products such as Glucophage.
In Canada, health regulator, in turn, said that it was not aware of any metformin products in Canada containing NDMA that is above acceptable limits. The US Food and Drug Administration (FDA) and the European Medicines Agency are running similar tests in their territories.
NDMA is a chemical byproduct from pesticides, chlorine and industrial processes and is classified as ‘probably carcinogenic to humans’.
People who have not reduced their blood sugar by eating healthily and exercising are usually prescribed the medicine, which comes as pills or a liquid.
The products that have been recalled in Singapore are called Glucient XR (500mg) and Meijumet prolonged-release (750mg and 1,000mg), the Straits Times reported.
The FDA in the US and Health Canada are also looking into whether products in their countries might be affected.
The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.Janet Woodcock, FDA’s Center for Drug Evaluation and Research
By the end of November, all products containing the contaminated medicine, ranitidine, had been taken off shelves and out of pharmacies in the UK.
The UK Department of Health and Social Care said it had banned doctors from prescribing them until further notice, over fears they contain a cancer-causing chemical.
Patients should continue taking Metformin to keep their diabetes under control. It may be harmful to patients with this serious condition to stop taking their metformin without first talking to their healthcare professional.
SAHPRA recommends that prescribers continue to use metformin when clinically appropriate, and as indicated, because investigations are still ongoing.
“SAHPRA, the custodian of health products in South Africa, is committed to ensure that all medicines comply with its three pillars: Quality, safety and efficacy. We will update the public once investigations are conclusive,” said Ms Portia Nkambule, Acting CEO of SAHPRA.
Source: South African Health Products Regulatory Authority (SAHPRA)