Another 25 batches of high blood pressure pills have been recalled over fears they may cause cancer, health chiefs announced today.
All of the affected medicines contain irbesartan, which is used to treat high blood pressure and prescribed to millions of Britons every year.
They are all also contaminated with a chemical impurity, which regulators warn may ‘increase the risk of cancer over time’.
The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, said the move was ‘precautionary’.
Some of the contaminated pills have been on the market since December 2018.
The medicines watchdog said there is ‘no evidence’ that the chemical impurity has caused any harm to patients.
It urged Britons not to stop taking the affected drugs without first consulting their GP, warning that abruptly ending the treatment can be risky.
It’s the latest in a line of recalls of sartan-based medicines, which are often made in factories in China and India.
Just last month the MHRA issued a recall for 31 batches of similar drugs containing the same impurity.
The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs used in Britain, said the move was ‘precautionary’. Several batches of Sanofi Aventis’ 150mg packets of Aprovel were affected by the recall
All of the affected medicines contain irbesartan, which is used to treat high blood pressure and prescribed to millions of Britons every year
TIMELINE OF COMMON BLOOD-PRESSURE DRUGS’ RECENT RECALLS
2012 – The blood-pressure medication valsartan is thought to have been contaminated with the cancer-causing, rocket-fuel chemical NDMA as far back as 2012.
European regulators warned last year the medication’s main manufacturer in China – Zhejiang Huahai Pharmaceutical – changed its manufacturing process seven years ago, which may have been to blame.
July 5, 2018 – The UK recalled the drug over growing concerns.
Many EU authorities then followed suit.
The European Medicines Agency said it was working to establish how long, and at what levels, patients might have been exposed to NDMA.
July 17 – The US Food and Drug Administration ordered a ban on valsartan’s prescription.
July 30 – China’s National Health and Family Planning Commission said the drug must not be used for diagnosis or treatment.
January 3, 2019 – The Medicines and Healthcare products Regulatory Agency recalled thousands of medications containing the blood-pressure drug irbesartan over NDEA fears.
The government-run body issued an alert over four batches of the medication and pulled the products – made by Actavis, now known as Accord – as a ‘precautionary measure’.
June 2021 – Pharmacies stocking 31 batches of affected drugs — several different types of irbesartan and losartan — were told to pull them after the cancer-causing impurity was detected
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The Government agency at the time claimed the affected batches contained azido-tetrazole, considered by some to be the world’s most explosive chemical.
The MHRA insisted the impurity was not actually azido-tetrazole and had only been shortened down because of its long chemical name.
Today’s product recall — sparked by the same impurity — lists the contaminant by its full name: (5-(4’-(azidomethyl)-[1,1’-biphenyl]-2yl)-1H-tetrazole).
The MHRA revealed the affected batches, which include different types of Aprovel, are being recalled because ‘the level of contamination is above the acceptable limit’.
The recall was only issued to pharmacies and wholesalers. It affects six suppliers and distributors.
Dr Alison Cave, MHRA chief safety officer, 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’s important that healthcare professionals check their stock to quarantine and return these batches.
‘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.
‘Previous recalls of these types of products in 2018, 2019 and June 2021 are part of an ongoing investigation.
‘The MHRA is working with other medicines regulators on this issue.’
Officials have yet to explain how the latest impurity may have occurred.
But they are often caused by contamination in factories or brought on during the manufacturing or storage process.
Exposure to light, temperatures or even reactions with the container that holds the drug can trigger chemical changes.
Overall, more than two-thirds of all active drug ingredients originate in China and India, industry experts estimate, with China accounting for the lion’s share.
NHS figures reveal more than 2million prescriptions for drugs containing irbesartan were dished out in England in 2017.
WHAT ARE THE IRBESARTAN AND LOSARTAN CONTAINING DRUGS THAT ARE AFFECTED? PRODUCT NAME BATCH NUMBER SUPPLIEREXPIRY DATE PACK SIZE Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017 9A111 Aventis Pharma Limited T/A Sanofi July 2022 28 Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017 9A118 Aventis Pharma Limited T/A Sanofi Oct 2022 28 Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788) 0R258 Aventis Pharma Limited T/A Sanofi Jan 2023 28 Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788) 0R855 Aventis Pharma Limited T/A Sanofi Sep 2023 28 Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788) 8R827 Aventis Pharma Limited T/A Sanofi Oct 2021 28 Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788) 9R217 Aventis Pharma Limited T/A Sanofi Dec 2021 28 Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788) 9R2N7 Aventis Pharma Limited T/A Sanofi Aug 2022 28 Aprovel 150mg Film-Coated Tablets, EU/1/97/046/022, (PLGB 04425/0788) 9R40E Aventis Pharma Limited T/A Sanofi Aug 2022 28 Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789) 0R262 Aventis Pharma Limited T/A Sanofi Jan 2023 28 Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789) 0R263 Aventis Pharma Limited T/A Sanofi Jan 2023 28 Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789) 8R830 Aventis Pharma Limited T/A Sanofi Oct 2021 28 Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789) 9R27A Aventis Pharma Limited T/A Sanofi Jun 2022 28 Aprovel 300mg Film-Coated Tablets, EU/1/97/046/027, (PLGB 04425/0789) 9R2N9 Aventis Pharma Limited T/A Sanofi Aug 2022 28 Co-Aprovel 150mg/12.5mg Film-Coated Tablets, EU/1/98/086/012, (PLGB 04425/0791) 0R824 Aventis Pharma Limited T/A Sanofi Apr 2023 28 Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017, (PLGB 04425/0792) 0R16E Aventis Pharma Limited T/A Sanofi May 202328 Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017, (PLGB 04425/0792) 0R2EL Aventis Pharma Limited T/A Sanofi Aug 2023 28 Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017, (PLGB 04425/0792) 8R962 Aventis Pharma Limited T/A Sanofi Oct 2021 28 Irbesartan Zentiva 75mg Film-Coated Tablets, EU/1/06/376/017 9A111 Zentiva Jul 2022 28 Aprovel 150mg Film-Coated Tablets, EU/1/97/046/004 FT050 Doncaster Pharmaceuticals Group Ltd Mar 2023 28 Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017 9A111 MPT Pharma Limited Jul 2022 28 Aprovel 75mg Film-Coated Tablets, EU/1/97/046/017 9A118 MPT Pharma LimitedOct 2022 28 Co-Aprovel 300mg/12.5mg Film-Coated Tablets, EU/1/98/086/017 FT013 PCO Manufacturing LtdFeb 2023 28 Aprovel 150mg Film-Coated Tablets, EU/1/97/046/004, (PLGB 18799/3988) FT050 Gowrie Laxmico Ltd T/A B&S Healthcare Mar 2023 28 Aprovel 150mg Film-Coated Tablets, EU/1/97/046/004, (PLGB 18799/3988) FT050 Gowrie Laxmico Ltd T/A B&S Healthcare Mar 2023 28 Co-Aprovel 150mg/12.5mg Film-Coated Tablets, EU/1/98/086/001, (PLGB 18799/3984) FT037 Gowrie Laxmico Ltd T/A B&S Healthcare Feb 202 28
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