A NEW alert has been issued over a common heartburn drug which was urgently recalled over fears it could contain cancer-causing chemicals.
Four types of prescription-only Zantac, used to treat heartburn and stomach ulcers, were urgently withdrawn in the UK last week.
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But now two more products have been added to the list – Ranitidine Effervescent Tablets 150 milligrams and 300 milligrams.
The Medicines and Healthcare products Regulatory Agency (MHRA) warned that there had been a possible contamination of the active substance in Zantac, ranitidine.
It had identified an impurity called NDMA – a risk factor in the development of certain cancers – in the medicines.
Precautionary measure
The agency said that the recall was a “precautionary measure”, but that it was actively working with the European Medicines Agency to determine the impact of the global issue.
A statement released today said: “The MHRA has issued an alert to healthcare professionals, as Teva UK Ltd is recalling all unexpired stock of certain batches of two types of Ranitidine medicines used to treat conditions such as heartburn and stomach ulcers.
“Healthcare professionals have been told to stop supplying the two products immediately. All remaining stock should be quarantined and returned without delay to the supplier.
“Patients should not stop taking their medication, and a treatment review is not necessary until the next routine appointment.”
Links to cancer
NDMA (N-nitrosodimethylamine) was once used to make rocket fuel, according to the Centers for Disease Control and Prevention (CDC) in the US.
People are typically exposed to NDMA from a variety of sources, including tobacco smoke, chewing tobacco, diet (from cured meats for example) and toiletries and other cosmetic products.
It can harm the liver, and while there are no reports of NDMA causing cancer in humans, the CDC warns, “it is reasonable to expect that exposure to NDMA by eating, drinking or breathing could cause cancer in humans”.
See your GP if you’re worried
Dr Andrew Gray, MHRA deputy director of inspections, enforcement and standards, said: “While this action is precautionary, the MHRA takes patient safety very seriously.
“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 world.”
Precautionary measure
Doctors and pharmacists have been told to stop handing out the drugs immediately, and return all stock to the drugs company, GlaxoSmithKline.
The MHRA said they are investigating other ranitidine medicines, which may also be affected and further updates will be provided.
The batches of Zantac affected are:
- Zantac 150mg/10ml Syrup
- Zantac 50mg/2ml Injection
- Zantac 150mg Tablets
- Zantac 300mg Tablets
- Ranitidine Effervescent Tablets 150 milligrams
- Ranitidine Effervescent Tablets 300 milligrams
MHRA added that over-the-counter versions of Zantac sold in UK pharmacies are not affected by the recall.
The full list of affected products is available on the MHRA website.
If you are worried, speak to your pharmacist or GP.
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