Metformin, a common diabetes drug taken by millions of people, is being investigated for a possible cancer-causing chemical, health officials have confirmed.
The drug is widely prescribed for treating type-2 diabetes. However, it is feared Metformin may be contaminated by possibly dangerous levels of cancer-causing agent, carcinogen N-Nitrosodimethylamine.
According to authorities, the presence of the cancer-causing chemical has resulted in previous recalls of other medications for heartburn and blood pressure.
In Singapore, health chiefs have recalled three metformin products after they were discovered to have ‘trace amounts’ of NDMA, which “are above the internationally acceptable level.”
Although it is not thought to cause harm when consumed at very low levels, the chemical is classified as a probable human carcinogen.
A spokesperson for The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK said: “Patients in the UK are advised to continue taking their metformin medicines as usual.
“The risks from not having adequate diabetes treatment far outweigh any possible effects of the low levels of NDMA seen in metformin medicines outside the UK.
“As these metformin medicines are also available in Europe and outside the EU, the MHRA is working closely with the European Medicines Agency (EMA) and other regulatory authorities to determine whether any further action is required and will continue to keep patients updated as more information becomes available.
“The levels of NDMA seen in the affected non-UK metformin medicines are very low and appear to be within or even below the range that people would normally be exposed from other sources, including food and water.”
A senior clinical advisor at Diabetes UK, Emma Elvin, said: “Many people use metformin to treat their type 2 diabetes – it is vital in helping manage the condition and reduces their risk of long-term complications.
“We recommend UK patients to continue taking metformin as prescribed, pending MHRA’s decision whether further action is required. If you have any concerns, please speak to your healthcare team.”
In the US, the Federal Drug Administration also said that it is investigating metformin.
“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,” a statement said. “The agency will also work with companies to test samples of metformin sold in the U.S. and will recommend recalls as appropriate if high levels of NDMA are found.
“If as part of our investigation, metformin drugs are recalled, the FDA will provide timely updates to patients and health care professionals.”
The FDA urged people taking the medicine to continue doing so without first consulting a doctor.
“These investigations take time,” said director of FDA’s center for Drug Evaluation and Research.
“We understand that these issues affect patients’ health and well-being in many ways, and the FDA’s goal is to provide patients and health care providers as much clarity and as many answers as possible to inform their health care decisions.”
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