'Precautionary' Recall of More Valsartan Medication

Peter Russell

December 03, 2018

Pharmacies have been asked to return batches of valsartan-containing medicine manufactured by Teva UK and Mylan after the Medicines and Healthcare products Regulatory Agency (MHRA) became aware they may contain a nitrosamine contaminant with "genotoxic and carcinogenic potential".

It followed similar action in July this year when the regulator recalled batches of valsartan-containing medication made by Accord Healthcare and Dexcel Pharma Ltd, after a different nitrosamine impurity, N-nitrosodimethylamine (NDMA), was detected in the manufacturing process.

At the time, the MHRA said that contaminant also had genotoxic and carcinogenic potential.

That Europe-wide recall followed information that the impurity had been identified at one facility based in China.

During the course of the investigation into NDMA, another contaminant, N-nitrosodiethylamine (NDEA), was discovered in valsartan active substance.

'No Evidence Patients Have Been Harmed'

At present there was no evidence that this impurity has caused any harm to patients, the MHRA said. Dr Sam Atkinson MHRA's director of the inspection, enforcement and standards division, commented: "We are undertaking a pharmacy level recall of all affected batches of valsartan-containing medicines made by Mylan and Teva.

"This is a precautionary measure to prevent any further exposure to the impurity in the affected medicines whilst the investigation continues, and further updates will be provided."

The regulator said healthcare professionals and wholesalers should:

  • Stop supplying specific batches of the listed products immediately.

  • Quarantine all remaining stock and return it to the supplier using the supplier's approved process.

  • If asked, advise patients not to stop taking their medication as the health risk of discontinuing medicine for hypertension is higher than the potential risk presented by the contaminant. A treatment review was not necessary until the next routine appointment.

The MHRA said it did not anticipate any shortages of valsartan containing products due to the recall. However, in the event of any local supply issues, patients should speak to their doctor to discuss alternative treatments.

The MHRA said it was actively involved with the European Medicines Agency (EMA) and with other medicines regulators to determine any possible impact in what was a "developing issue".

It said an investigation was continuing into other sartan products which share a similar chemical structure to valsartan.


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