Cancer-causing chemicals spark THIRD recall of blood pressure drugs over contamination fears

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THOUSANDS of heart patients are being told to check their medication after an urgent recall, health experts said today.

Pharmacies across the country are advised to recall batches of the drug irbesartan.

Three batches of heart drugs have been recalled today, amid fears of contamination with cancer-causing chemicals (stock image)
Three batches of heart drugs have been recalled today, amid fears of contamination with cancer-causing chemicals (stock image)
Getty – Contributor

It is the third recall of its kind, since the start of the year.

The Medicines and Healthcare products Regulatory Agency (MHRA) said there are concerns the drug could contain cancer-causing chemicals.

Three more batches have been recalled today, weeks after the same drug supplied by Accord and Dexcel were recalled, and more batches from Macleods Pharma UK were affected.

Today’s recall affects batches made by Actavis Pharma UK Limited, the MHRA said.

Don’t stop taking drugs, but see your GP – patients told

The advice to patients is not to stop their medication, as that could put lives at risk.

But people are being urged to see their GP if they think they are at risk.

There is no evidence that the medication has caused harm to patients, the MHRA stressed.

Dr Sam Atkinson MHRA’s Director of the Inspection, Enforcement and Standards Division said: “Patient safety is our top priority and we will take any necessary steps to protect public health.

“Today’s Irbesartan recall shows we are continuing to investigate potential contamination of sartan containing medicines.

“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.”

Drugs that treat high blood pressure, heart attack and heart failure

Sartans are a class of medications used to treat high blood pressure, heart attack and heart failure.

It follows an earlier recall of heart medications Dexcel and Actavis in July and Mylan and Teva in November, which contained the same chemical.

The recall occurred across Europe and came after an urgent investigation was launched in to medicines containing another sartan drug, valsartan, produced at a facility in China.

Drugs are being recalled across Europe, as experts fear impurities (N-nitrosodimethylamine and N-nitrosodiethylamine), which could be carcinogenic, could be found in the drugs as a result of a change in the manufacturing process.

“Currently there is no evidence that medicines containing NDMA or NDEA have caused any harm to patients,” Dr Atkinson added.

The European Medicines Agency and other EU regulators are working together to investigate how widespread the problem is, and the possible impact for patients.

THREE BATCHES RECALLED TODAY

THESE are the three batches of Actavis Pharma UK Ltd drugs being recalled.

1. Irbesartan 300mg film-coated tablets, PL30306/0108

Batch number – 191018

Expiry date – 05/2020

Pack size – 1×28

First distributed – Nov 30, 2018

2. Irbesartan 300mg film-coated tablets, PL30306/0108

Batch number – 191118

Expiry date – 05/2020

Pack size – 1×28

First distributed – Dec 20, 2018

3. Irbesartan / Hydrochlorothiazide 300 / 25mg Film-coated Tablets, PL 30306/0267

Batch number – 263918

Expiry date – 06/2020

Pack size – 1×28

First distributed – Nov 21, 2018

 

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