- The Medicines and Healthcare products Regulatory Agency issued the alert
- It revealed four batches of pills containing irbesartan have been recalled
- All the products pulled as a ‘precautionary measure’ are made by Actavis
- Do you take any of the pills? Contact stephen.matthews@mailonline.
co.uk
Regulators have recalled thousands of blood pressure pills from pharmacies amid fears they could cause cancer.
Four types of medications branded as Irbesartan Hydrochlorothiazide have been pulled from shelves because they could contain a carcinogenic ingredient once used in rocket fuel.
It is the latest in a batch of recalls affecting blood pressure drugs and could impact thousands of patients with hypertension – the medical term for high blood pressure.
Officials have yet to explain how the contamination may have occurred – but changes in the manufacturing process were blamed for producing the same potent chemical in other pills that have been recalled worldwide.
The Medicines and Healthcare products Regulatory Agency issued the alert over four batches of medications containing irbesartan (pictured, a version of the drug recalled in Hong Kong)
The Medicines and Healthcare products Regulatory Agency (MHRA) today announced it pulled four batches of the tablets as a ‘precautionary measure’ due to possible N nitrosodiethylamine (NDEA) contamination.
It insisted there is ‘no evidence’ the impurity has caused any harm to patients and it reiterated that not all products containing the ingredient irbesartan are affected.
It is unclear how many of the affected products, all made by Actavis – now known as Accord – will be recalled.
NHS figures reveal more than 2million prescriptions for drugs containing irbesartan were dished out in England in 2017. Around 165,000 of these are thought to be for Irbesartan Hydrochlorothiazide.
The warning by the MHRA, issued today, follows the worldwide recall of blood pressure drugs containing an ingredient called valsartan.
Investigators found NDMA – a chemical similar to NDEA – had contaminated the chemical‘s production at Zhejiang Huahai, a Chinese supplier.
Seven batches of the drug, made by Actavis and Dexcel Pharma Ltd, were initially recalled last July across Europe. The US followed two weeks later.
The MHRA issued another recall of more batches of drugs containing valsartan made by Mylan and Teva in November for containing NDEA.
The MHRA has now urged patients to not stop taking their medication, on the back of the new irbesartan alert. The drugs are dished out to treat high blood pressure.
Health officials in Hong Kong issued a recall of one of the affected products made by Actavis two weeks ago – on December 20.
US drug regulators, the FDA, announced in November that Indian pharmaceutical firm, Aurobindo Pharma Ltd, had recalled 22 products containing irbesartan amid fears they also had the NDEA impurity.
EU officials then announced they were ‘considering’ whether to recall medicines containing the Indian firm’s irbesartan as a precaution. It was then suspended from supplying the chemical to other firms in Europe.
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.
In strict guidance issued to pharmacists, the MHRA told them to stop supplying the affected batches ‘immediately’.
The warning continued: ‘Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.’
Dr Sam Atkinson, MHRA’s Director of the Inspection, Enforcement and Standards Division said: ‘Our highest priority is making sure the medicines you take are safe.
‘Our investigation into potential contamination of sartan containing medicines, including irbesartan, is ongoing.
‘At present, there is no evidence that medicines containing NDMA or NDEA have caused any harm to patients.
Four other irbesartan-containing medications made by Accord are unaffected (pictured: the company’s premises in Harrow, London)
Because of the risk associated with suddenly stopping high blood pressure medication, people are advised not to stop any treatments without consulting their doctor or pharmacist.’
The MHRA said it was ‘working closely’ with the European Medicines Agency to conduct a thorough investigation over how the impurity occurred.
Other forms of sartans, known as angiotensin-II-receptor antagonists, are being tested to see if they also contain impurities.
Four other irbesartan-containing medications made by Accord are unaffected.
In the wake of the emerging scandal last year, the EMA said routine tests carried out by Zhejiang Huahai did not detect NDMA because it was an unexpected impurity.
Officials added at the time that the manufacturing changes introduced in 2012 by the Chinese firm were believed to have produced NDMA as a by-product.
The MHRA has now urged patients to not stop taking their medication, on the back of the new irbesartan alert. The drugs are dished out to treat high blood pressure
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