Health chiefs recall dozens of batches of common blood pressure pills because they contain cancer-causing chemical

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  • The pharmacies stocking the pills immediately asked for it to be pulled and quarantined supplies
  • Pills found to contain ‘unacceptable’ level of potentially cancer-causing substance
  • Patients should still carry their prescription because the health risk of stopping is too high.

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Dozens of batches of blood pressure pills have been recalled for being contaminated with ‘unacceptable’ levels of a potentially cancer-causing chemical.

Pharmacies and health professionals were ordered to immediately stop supplying 44 batches of the drug irbesartan and to quarantine all remaining stock after a substance called ABZT was found.

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ABZT has been shown in laboratory tests to cause tumors if people are exposed to it for a long time.

However, the risk posed by impurity at the levels found in drugs so far has been very low.

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Patients on irbesartan are still being advised to take their medication, which reduces their risk of heart attack and stroke, because the risks of not taking it are greater.

Britain’s medical watchdog said the move was purely precautionary and there was no evidence it caused any harm to patients.

The Medicines and Healthcare products Regulatory Agency (MHRA), which regulates the safety of drugs used in the UK, said the move was a ‘precautionary’.

Officials say the affected batches under the brand name Aprovel include more than 1,200 tablets distributed since November 2019.

Most of the batches were delivered in 2020, but some have been scheduled as June this year.

Timeline of common blood pressure drugs’ recently recalled

2012 – The blood pressure drug valsartan was believed by 2012 to be contaminated with the cancer-causing, rocket-fuel chemical NDMA.

European regulators last year changed its manufacturing process to seven years ago after the drug’s main maker in China – Zhejiang Huahai Pharmaceutical – could be to blame.

5 July 2018 – The UK withdrew the drug over growing concerns.

Several EU officials then followed suit.

The European Medicines Agency said it is working to establish how long and at what level patients may have been exposed to NDMA.

17 July – The US Food and Drug Administration ordered a ban on the prescription of valsartan.

30 July – China’s National Health and Family Planning Commission said this drug should not be used for diagnosis or treatment.

3 January 2019 – The Medicines and Healthcare products Regulatory Agency has recalled thousands of drugs containing the blood pressure drug irbesartan over fears of the NDA.

The government-run body issued an alert over four batches of the drug 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 they were discovered to be a cancer-causing impurity.

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NHS figures indicate that over 2 million people in England are prescribed drugs containing irbesartan.

The drug is prescribed to treat high blood pressure and to help prevent heart attacks and strokes in at-risk patients.

ABZT, known as azidomethyl-biphenyl-tetrazole, is a chemical compound that may form during the manufacture of certain blood pressure medications called sartans.

It is known to damage DNA, and prolonged exposure over years can increase a person’s risk of developing cancer.

Dr Alison Cave, Chief Safety Officer, Medicines and Healthcare products Regulatory Agency, said: ‘This recall is a precautionary measure to prevent further exposure to AZBT above acceptable safety limits.

‘There is no evidence that this substance has caused any harm to patients.

‘It is extremely important that you continue to take your medicine but if you have any questions contact your doctor or pharmacist.’

Dr Kew said that MHRA has urged pharmaceutical companies to implement control measures to prevent ABZT from reaching unacceptable levels in medicines.

“MHRA has asked companies to implement control measures to ensure that the level of the substance is at or below the required level,” she said.

‘We are also working with our international counterparts, given that this is a global issue, to ensure the safety of patients.’

It is the latest in a line of recalls of sartan-based drugs, which are used to treat blood pressure and are often made in factories in China and India, issued by the MHRA.

Similar recalls have been made twice this year in June and August for irbesartan and the other sartan-based drug, losartan.

But the problem is back in 2019 and 2018 with other recalls caused by similar fears of mutagenic

Officials have not yet clarified how these contaminations may have occurred as the investigation is still ongoing.

But they are often caused by contamination in factories or brought in during the manufacturing or storage process.

The MHRA said it is continuing to work with the health department to ensure that adequate supplies of these drugs are still reaching patients who need them.

Patients who have concerns about their taking irbesartan are urged to contact their pharmacist or GP.

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