Two more UK companies recall their versions of Zantac heartburn drug over fears they are contaminated with a cancer-causing chemical
- The medicines affected are prescription-only and not sold over the counter
- Supplies of ranitidine, the generic ingredient, are affected in the UK and US
- Medicine watchdogs said people should not stop taking their medicines
- But healthcare professionals should not keep prescribing the medications
- Ranitidine drugs made by the companies Creo Pharma and Tillomed are recalled
Two more UK pharmaceutical companies are recalling their versions of the heartburn drug Zantac over fears they are contaminated with a cancer-causing chemical.
Ranitidine, the generic medical name for Zantac, has been the subject of global drug recalls since September.
Traces of a chemical linked to various types of cancer – N-nitrosodimethylamine – have been discovered in the prescription medicines’ ingredients.
Pharmacies have now been warned not to dispense ranitidine heartburn products produced by the companies Creo Pharma and Tillomed Laboratories.
This is the fourth warning made by the British watchdog the Medicines & Healthcare products Regulatory Agency (MHRA), after three others in October.
Creo Pharma is recalling its 30mg/ml ranitidine oral solution, making it the latest of a string of companies to stop selling their products containing the heartburn drug
‘Whilst this action is precautionary, the MHRA takes patient safety very seriously,’ said deputy director of enforcement, Dr Andrew Gray.
‘Patients should keep taking their current medicines but should speak to their doctor or pharmacist if they are concerned and should seek their doctor’s advice before stopping any prescribed medicines.
‘We have asked companies to quarantine batches of potentially affected medicines whilst we investigate and we will take action as necessary, including product recalls where appropriate.
‘We have also requested risk assessments from the relevant companies which will include the testing of potentially affected batches.
‘Currently, there is no evidence that medicines containing nitrosamines have caused any harm to patients, but the Agency is closely monitoring the situation, and working with other regulatory agencies around the world.’
Creo Pharma is recalling its 30mg/ml ranitidine oral solution, and Tillomed its 150mg ranitidine tablets.
The MHRA told healthcare professionals to stop giving out the ranitidine products, quarantine them and returned to their suppliers.
The recall adds to one by GlaxoSmithKline, which makes the brand-name Zantac.
Teva UK, Rosemont Pharmaceuticals, Boots and Morrisons all also had to stop selling their own versions of the generic ranitidine.
N-nitrosodimethylamine (NDMA) is chemical which can develop in water when certain chemicals, such as pesticides, chlorine and ammonia or fuels break down.
It is classified as ‘probably carcinogenic’ by the World Health Organization’s International Agency for Research on Cancer.
This means it may contribute to cancer, and the WHO suggests it can do so by disrupting enzymes in the liver and damaging DNA.
Zantac and similar drugs have also been recalled in the US – GlaxoSmithKline sells its branded version of the product around the world.
HOW THE ZANTAC RECALLS HAVE UNFOLDED
JUNE – Online pharmacy Valisure detects NDMA in some batches of Zantac and tells the US Food and Drug Administration (FDA)
SEPTEMBER 13 – The FDA confirms some batches of ranitidine pills, including Zantac, contain trace amounts of NDMA and launch an investigation
Valisure asks the FDA to recall all products containing ranitidine. It says the impurity was the result of the ‘inherent instability’ of the ranitidine molecule, claiming every ranitidine-based drug could be affected
SEPTEMBER 18 – Pharmaceutical giant Novartis’s subsidiary firm Sandoz stops distributing its prescription form of ranitidine worldwide
SEPTEMBER 20 – Italian health chiefs recall more than 500 drugs containing ranitidine made by Indian manufacturer Saraca Laboratories because of the NDMA impurity fears
SEPTEMBER 23 – The Irish equivalent to the MHRA – the Health Products Regulatory Authority – recalls 13 medications containing ranitidine, including seven versions of Zantac. It says the fault comes from the manufacturing plant of the chemical in India
Sandoz recalls its generic version of ranitidine in the US
SEPTEMBER 24 & 25 – GlaxoSmithKline recalls four different types of Zantac in Hong Kong. The next day, it pulls the drug in India, where it is branded as Zinetac. It also halts global distribution of the popular medicine
French health officials recall all branded and generic versions of ranitidine. Canadian chiefs reveal Apotex Inc, Pro Doc Limitée, Sanis Health Inc and Sivem Pharmaceuticals ULC are all recalling their ranitidine drugs
SEPTEMBER 28 – US retailer CVS removes Zantac and its own generic ranitidine products from 6,200 of its stores over NDMA fears
OCTOBER 1 – Walgreens and Rite Aid announce they are both pausing sales of Zantac and ranitidine over the same fears
OCTOBER 2 – GlaxoSmithKline voluntarily recalls its other two types of ranitidine tablets in Ireland
OCTOBER 8 – GSK recalls four prescription-only types of Zantac in the UK
OCTOBER 17 – Teva UK issued a nationwide recall for batches of two types of ranitidine
NOVEMBER 19 – Creo Pharma and Tillomed Laboratories recall their 150mg ranitidine tablets and 30mg/ml oral solution, respectively