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One batch of an oral solution of metformin, involving 10,452 “units”, is being requested back by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to contain an amount of nitrosamine “above accepted levels”.
The compound nitrosodimethylamine (NDMA) is 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 their treatments without consulting their doctor or pharmacist. The body added that there is no evidence to suggest they will have been harmed.
The 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.”
The MHRA said the move only affected a single batch supplied by Leeds-based Rosemont Pharmaceuticals. Chief safety officer Dr Alison Cave said: “Patient safety is at the heart of everything we do. This recall is a precautionary measure to prevent further exposure to the nitrosamine impurity.
“There is no evidence this has caused any harm to patients.
“Individuals who have metformin oral solution from this batch 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.
“Healthcare professionals should check their stock to quarantine and return any units from this batch to their supplier.”
Metformin lowers blood sugar levels by improving the way the body handles insulin. It is widely used to treat Type 2 diabetes and prescribed when diet and exercise have not been enough to control blood sugar levels.
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