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Diabetes drug recalled after being found to contain cancer-causing chemical

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Diabetes drug recalled after being found to contain cancer-causing chemical

A batch of the diabetes drug metformin has been recalled after it was found to have unacceptable levels of a cancer-causing chemical impurity.

One batch of an oral solution of the drug - involving 10,452 "units" of medicine - is being recalled by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to contain a nitrosamine impurity "above accepted levels".

Nitrosodimethylamine (NDMA) has been identified as a risk factor in the development of certain cancers.

Patients do not need to do anything as the recall has only been issued to pharmacies and wholesalers.

The MHRA said patients should not stop any treatments without consulting their doctor or pharmacist.

It added there is no evidence to suggest patients have been harmed.

a close up of a cake: Nitrosodimethylamine (NDMA) has been identified as a risk factor in the development of certain cancers

© Corbis via Getty Images Nitrosodimethylamine (NDMA) has been identified as a risk factor in the development of certain cancers

The medicines regulator said: "During testing prior to batch release, levels of the impurity NDMA in batch number 0LL0018 of metformin oral solution were found to be within acceptable limits.

"However routine monitoring of the batch while on the market showed that levels of NDMA were no longer acceptable at nine months."

a close up of a bottle: One batch of an oral solution of the drug - involving 10,452

© Corbis via Getty Images One batch of an oral solution of the drug - involving 10,452

No other batches have been found to be affected, it said.

Dr Alison Cave, MHRA chief safety officer, said: "Patient safety is at the heart of everything we do.

"This recall of one batch of metformin oral solution is a precautionary measure to prevent further exposure to the nitrosamine impurity.

"There is no evidence to date that this impurity has caused any harm to patients.

"Individuals who have metformin oral solution from this batch at home should continue to take their medication.

"It is very important to speak to your doctor or pharmacist before stopping any treatment - they can address any concerns you may have and can advise you on the best course of action.

"Healthcare professionals should check their stock to quarantine and return any units from this batch to their supplier using their supplier's approved process." 

Reference: Mirror: Abigail O'Leary

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