UK doctors have been issued to stop prescriptions to four types of heartburn medications called Zanatac and ranitidine as a “precautionary measure”.
The move is followed by concerns raised by several countries that such products contain impurity linked to cancer. The four drugs in question are Zantac 150mg/10ml Syrup, Zantac 50mg/2ml Injection, Zantac 150mg Tablets and Zantac 300mg Tablets.
Officials however advise, patients should continue taking their prescribed medicine.
According to the Medicines and Healthcare products Regulatory Agency (MHRA), if the medicine is discontinued, the health risk is greater as compared to the potential risk by contaminant N-nitrosodimethylamine (NDMA). Furthermore, it adds, anyone concerned about the medication should consult the doctor or the pharmacist.
On basis of animal studies, NDMA is identified as a human carcinogen, or a substance that could cause cancer. Reports allege, it is present in some foods and also in water supplies, however it is not expected to cause any harm when consumed in low levels.
The MHRA has thus asked manufacturers to quarantine all products which may contain the active pharmaceutical ingredient (API).
The recalled drugs in question are made by GlaxoSmithKline (GSK).
Over-the –counter products which people can buy in pharmacies without a prescription are however not affected by the recall and are manufactured by another company. These include Zantac 75 Relief (PL 02855/0081 [GSL]) and Zantac 75 Tablets (PL 02855/0082 [P].
According to sources, MHRA is analyzing other ranitidine medicines which may also be possibly affected.
Experts report, there is no solid evidence that patients are affected by this type of impurity.
Dr Andrew Gray from the MHRA said with regards to the situation: “Whilst this action is precautionary, the MHRA takes patient safety very seriously.
“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.”
Tags : UK Doctors, Zanatac, NDMA, MHRA , GlaxoSmithKline, GSK, Dr Andrew Gray, Over-the-counter products,