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.