The Medicines and Healthcare Regulatory Agency (MHRA) has issued a drug alert, as Creo Pharma Limited and Tillomed Laboratories have recalled their unexpired stock of prescription-only ranitidine.
GSK’s formulation of the drug, called Zantac and used for heartburn and stomach ulcers, was recalled in the USA last month after the US Food and Drug Administration (FDA) found “unacceptable” levels of carcinogen in the medicine due to a possible contamination with N-nitrosodimethylamine (NDMA).
The federal agency released a statement alerting patients to the possible contamination, after investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year.
NDMA, the chemical in question, is classified as a “probable human carcinogen”, based on results from laboratory tests. It is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables.
The UK recall has affected ranitidine Oral Solution 30mg/ml produced by Creo Pharma Limited, and ranitidine 150mg Tablets, produced by Tillomed Laboratories.
The regulatory agency has demanded healthcare professionals stop supplying the products immediately, and that all remaining stock should be quarantined and returned without delay to the supplier.
It did, however, advise that patients should not stop taking their medication, and a treatment review is not necessary until the next routine appointment.
The MHRA has “requested risk assessments from the relevant companies which will include the testing of potentially affected batches.”
Dr Andrew Gray, MHRA deputy director of inspections, enforcement & standards also confirmed that “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.”
The MHRA is actively involved with the European Medicines Agency (EMA) and other medicines’ regulators to determine the impact of what is now an ongoing, global issue.