MHRA recalls batches of irbesartan
The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled three batches of irbesartan as an investigation into possible N-nitrosodiethylamine (NDEA) contamination of sartan-containing medicines continues.
The MHRA stressed there was “no evidence the NDEA impurity can cause harm” and said patients were being told to continue taking their medication.
However, the potential contamination of medicines used to treat blood pressure, heart attacks and heart failures has prompted the regulator to recall the affected batches.
“Patient safety is our top priority and we will take any necessary steps to protect public health,” said Dr Sam Atkinson, the MHRA’s director of the inspection, enforcement and standards division.
“Today’s irbesartan recall shows we are continuing to investigate potential contamination of sartan-containing medicines.
“There is no evidence at present that medicines containing NDMA or NDEA have caused any harm to patients the recall is occuring as a precaution.
“Because of the risk associated with suddenly stopping high blood pressure medication, continue to take your medicines as prescribed by your doctor.
“Please speak to your doctor or pharmacist if you have any concerns about your medicine.”
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