Health chiefs recall 44 batches of common blood pressure pills because they contain cancer-causing chemical
Dozens of batches of a blood pressure pills have been recalled due to 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 quarantine all remaining stock after they were found to contain a substance called ABZT.
ABZT has been shown in lab tests to cause tumours if people are exposed to it over a long period of time.
然而, the risk posed by the impurity at the levels detected in medicines to date is very low.
Patients on irbesartan are still being advised to take their medication, which reduces the risk of heart attack and stroke, as the dangers of not taking it are higher.
Britain’s medical watchdog said the move was purely precautionary and there was no proof it has caused any harm to patients.
药品和保健产品监管局 (MHRA), which polices the safety of drugs used in Britain, said the move was ‘precautionary’
Officials say the affected batches, under the brand name Aprovel, consist of more than 1,200 pills distributed since November 2019.
Most of the batches distributed in 2020 but some have been prescribed as recently June this 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.
七月 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.
七月 17 – The US Food and Drug Administration ordered a ban on valsartan’s prescription.
七月 30 – China’s National Health and Family Planning Commission said the drug must not be used for diagnosis or treatment.
一月 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’.
六月 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
NHS figures indicate more than 2million people are prescribed drugs containing irbesartan in England.
The drug is prescribed to treat high blood pressure and is prescribed to help prevent heart attacks and strokes in at risk patients.
ABZT, known as azidomethyl-biphenyl-tetrazole is a chemical compound that can form during the manufacturing of some blood pressure medicines known as sartans.
It is known to damage DNA, and long-term exposure over years could increase a person’s risk of developing cancer.
Medicines and Healthcare products Regulatory Agency, chief safety officer, Dr Alison Cave, 说过: ‘This recall is a precautionary measure to prevent further exposure to AZBT above the acceptable safety limit.
‘There is no evidence that this substance has caused any harm to patients.
‘It’s vitally important that you continue to take your medicine but do contact your doctor or pharmacist if you have any questions.’
Dr Cave added that the MHRA has demanded drug companies implement control measures to prevent the ABZT reaching unacceptable levels in drugs.
‘The MHRA has asked companies to implement control measures to ensure that the levels of the substance are at or below the required level,’ 她说.
‘We are also working with our international counterparts, given this is a global issue, to ensure the safety of patients.’
This is the latest in a line of recalls of sartan-based medicines, 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 twice this year, in June and August for irbesartan and other sartan based medicine, losartan.
But the problem goes back further with other recalls being made in 2019 和 2018 over similar fears of mutagenic
Officials have yet to explain how the these contaminations may have occurred as investigations are still ongoing.
But they are often caused by contamination in factories or brought on during the manufacturing or storage process.
The MHRA said it is continuing to work with the Department of Health to ensure an adequate supply of these medicines are still reaching the patients that need them.
Anyone patients with concerns about taking their irbesartan is urged to contact their pharmacist or GP.