MHRA issues fourth recall for sartan-containing products

The Medicines and Healthcare products Regulatory Agency says this latest recall is a precautionary measure owing to contamination fears.
MHRA issues fourth recall for sartan-containing products

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class two medicines recall to pharmacies and wholesalers for 25 batches of irbesartan-containing medicinal products owing to contamination with an impurity that could increase the risk of cancer.

The recall includes products manufactured by Aventis Pharma Limited T/A Sanofi and Zentiva.

This is the fourth time a recall has been issued by the MHRA for sartan-containing products. Previous recalls occurred in November 2018 for valsartan-containing products, January 2019 for irbesartan-containing products and June 2021 for irbesartan and losartan-containing products.

In a recall issued on 9 August 2021, the MHRA stated that this latest recall was “a precautionary measure” to prevent further use and that there was no evidence that the impurity — 5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole — had caused any harm to patients. The statement also highlighted that this was not a “patient-level” recall and that patients should not stop any treatments without consulting their healthcare team.

Commenting on the recall, Alison Cave, chief safety officer at the MHRA, said: “Patient safety is at the heart of what we do.

“We’re recalling batches of certain sartan-containing products as a precautionary measure while we continue our investigation. It is important that healthcare professionals check their stock to quarantine and return these batches,” she said.

“If you’ve been taking one of the affected products, continue to take your medication. Speak with your doctor or pharmacist before stopping any treatment — they can address any concerns and can advise you on the best course of action.”

Sartan-containing medicines are indicated for essential hypertension, heart failure, and treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive regimen.

In January 2019, when the UK was a member of the EU, the European Medicines Agency recommended that sartan manufacturers review their processes to avoid contamination from impurities, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which are classified as possible human carcinogens.

According to the latest alert from the MHRA, there are no anticipated shortages of irbesartan-containing products in the UK as a result of this recall, but the MHRA is working with marketing authorisation holders and other medicines regulators to determine any possible impact.

An investigation into other potentially impacted products is continuing and further updates will be provided as the investigation progresses.

Read more: EMA recommends sartan manufacturers review manufacturing processes

Last updated
The Pharmaceutical Journal, PJ, August 2021, Vol 307, No 7952;307(7952)::DOI:10.1211/PJ.2021.1.100283

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