Health officials announce ANOTHER recall of blood pressure pills in the UK amid fears they contain a cancer-causing chemical
- Film-coated irbesartan pills supplied by Macleod Pharma UK are being recalled
- The recall is part of a contamination scandal stretching back to July 2018
- Patients shouldn’t stop taking medication but speak to a pharmacist if worried
More blood pressure and heart medications have been recalled today amid concerns they contain a chemical linked to cancer.
The recall is the latest in a months-long scandal with irbesartan, a drug prescribed to patients with high blood pressure or kidney disease.
Pharmacies have been told not to dispense three batches of the pills, just a day after a US company announced a similar recall there.
Today’s announcement concerns 150mg and 300mg irbesartan pills supplied by Macleods Pharma UK. Other recalls have concerned other firms.
Patients who use the medication should not stop taking their pills but speak to a pharmacist if they have concerns, officials have said.
The Medicines and Healthcare products Regulatory Agency has already issued a recall notice for all Irbesartan-containing medications made by Actavis (pictured) – today’s recall adds in medications supplied by Macleods Pharma UK
The products containing irbesartan are being called back by the Medicines and Healthcare products Regulatory Agency (MHRA).
Medicines based on sartan chemicals have been involved in the saga since the summer of 2018, when they were found to be contaminated.
Testing revealed some batches contained traces of a chemical called N nitrosodiethylamine (NDEA).
NDEA is classed by the World Health Organization as cancer-causing and is found in tobacco smoke.
Investigations into its presence in pharmaceutical products are continuing and multiple recalls have been announced in the UK and US in recent months.
‘Currently, there is no evidence that medicines containing NDMA or NDEA have caused any harm to patients,’ said Dr Sam Atkinson, the MHRA’s director of inspection, enforcement and standards.
|PRODUCT NAME||BATCH NUMBER||EXPIRY DATE||PACK SIZE||PL NUMBER|
|Irbesartan 150mg Film-coated tablets||EIZ807A||July 2021||1 x 28||34771/0079|
|IIrbesartan 300mg Film-coated tablets||EIA1813A||July 2021||1 x 28||34771/0080|
|Irbesartan 300mg Film-coated tablets||EIA1811A||July 2021||1 x 28||34771/0080|
‘Because of the risk associated with suddenly stopping high blood pressure medication, continue to take your medicines as prescribed by your doctor.
‘If you have any concerns about your medicine, please speak to your doctor or pharmacist.
‘Our most important concern is the safety of the medicines you take.
‘As today shows, we continue to investigate potential contamination of sartan containing medicines such as irbesartan.’
The medicine is only being recalled from pharmacists – patients need not take any action – and is only a precautionary measure, the MHRA said.
Patients would put themselves at more risk by stopping their medication than by continuing to take it, the agency said.
Earlier this month, MHRA advised pharmacies to recall all affected batches of irbesartan-containing medicines made by the firm Actavis.
In 2018, the agency twice recalled batches of another blood pressure and heart disease drug called valsartan.
The initial recall occurred after an impurity similar to NDEA, N-nitrosodimethylamine (NDMA), was identified at a facility in China. NDEA was discovered later.
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 (MHRA) 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’.
January 23, 2019 – Prinston Pharmaceutical Inc, a medicine company in the US, announced it was voluntarily recalling irbesartan and irbesartan HCTZ after finding higher levels of NDEA in them than the Food and Drug Administration permits.
January 24, 2019 – The UK’s MHRA issued a further recall of three more batches of irbesartan, this time concerning 150mg and 300mg film-coated tablets supplied by Macleods Pharma UK.