Regulators have recalled thousands of blood pressure pills from pharmacies amid fears they could cause cancer.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued the alert over four batches of medications containing irbesartan.
All tablets pulled by the body as a ‘precautionary measure’ are sold as Irbesartan Hydrochlorothiazide, made by Actavis – now known as Accord.
The MHRA, which polices the safety of medical products in the UK, said they were recalled due to possible N nitrosodiethylamine (NDMA) contamination.
NDMA – once used in rocket fuel – is thought to be carcinogenic, meaning it could cause cancer in humans.
NHS figures reveal more than 2million prescriptions for drugs containing irbesartan were dished out in England in 2017.
Of these, around 165,000 are thought to be of the four affected products, which all contain hydrochlorothiazide.
The MHRA insisted there is ‘no evidence’ the impurity has caused any harm to patients and it reiterated that not all irbesartan products are affected.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued the alert over four batches of medications containing irbesartan (stock)
The warning by the MHRA, issued today, follows the worldwide recall of another blood pressure drug, Valsartan.
Investigators found NDMA had contaminated the drug’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 Valsartan containing medicines made by Mylan and Teva in November for containing another similar impurity.
The MHRA has now urged patients to not stop taking their medication, on the back of the new irbesartan alert. Health officials in Hong Kong issued a recall of one of the affected products two weeks ago – on December 20.
In strict guidance issued to pharmacists, the MHRA told them to stop supplying the affected batches ‘immediately’.
|PRODUCT NAME||BATCH NUMBER||EXPIRY DATE||PACK SIZE||PL NUMBER|
|Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets||059118||31/03/2020||1 x 28||30306/0266|
|Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets||099218||31/03/2020||1 x 28||30306/0266|
|Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets||191418||31/03/2020||1 x 28||30306/0266|
|Irbesartan / Hydrochlorothiazide 150/12.5mg Film-coated Tablets||150118||31/03/2020||1 x 28||30306/0265|
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.
‘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.
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.
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 NDMA 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’.