Medicines regulation and law
More valsartan products recalled
Recall of valsartan products is expanded as investigations into manufacturing processes continue.
A further product recall for heart and blood pressure drug valsartan has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
The recall includes batches of the medicine that contain drugs supplied by Teva and Mylan.
It follows a pharmacy-level recall of valsartan in July 2018, when affected batches containing drugs from Dexcel and Actavis — now Accord — were recalled across Europe.
The July recall was prompted by the identification of a highly toxic impurity, N-nitrosodimethylamine (NDMA), as part of the manufacturing process in certain factories in China. During the investigation into NDMA, another toxic impurity, N-nitrosodiethylamine (NDEA), was discovered in valsartan drug substances.
The MHRA said in the recall notice that it and its European counterparts were continuing to investigate products that share a similar chemical structure to valsartan and may have been affected by similar quality control failures in their manufacture.
The MHRA added that there was currently “no evidence that this impurity has caused any harm to patients”, and that this recall was being carried out “as a precautionary measure to prevent further exposure to this impurity in the affected medicines whilst the investigation is ongoing”.
Sam Atkinson, director of the inspection, enforcement and standards division at the MHRA, said because of the risk associated with suddenly stopping antihypertensive medicine, “people are advised not to stop any treatments without consulting their doctor or pharmacist”.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2018.20205835
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