The European medicines Agency has recalled certain stomach acid blocker with a potentially cancer-causing Compounds. It is a medication with the active ingredient ranitidine, such as the Federal Institute for drugs and medical devices (BfArM) informed.
Ranitidine-containing medicines are used in the case of heartburn, for the treatment of a so-called reflux disease, and for prophylaxis of gastric ulcers. “An acute patient risk,” it said at the same time.
Recalled were all batches of medicinal products from the manufacturer Saraca Laboratories Limited manufactured active ingredient ranitidine contain. There is evidence available that the drug manufacturer of the impurity could be affected.
A list of the previously-affected drugs is to be found at this Link at the Federal Association of German pharmacy associations (ABDA), and it is constantly updated.
Preventive Health Protection
It is a matter of contamination with so-called N-nitroso dimethyl amine (NDMA), better known as nitro, amine, reported to the BfArM. The International Agency for research on cancer of the world health organization (WHO) classifies the substance as a probable carcinogen. “In the case of a recording of very small quantities have no harmful effect is to be expected,” writes the Federal Institute.
So far, not for all of ranitidine-containing medicines, it should be known whether, and in what concentrations they contained an impurity. The recall of successes, therefore, for reasons of preventive health protection. The possible hazard potential is currently being assessed at European level, scientifically, informed the BfArM.
Stomach acid blockers: medicine for millions of
In Germany, swallowing millions of people stomach acid blockers called proton pump inhibitors. They are either require a prescription or are sold with lower amounts of active Ingredient without a prescription directly to the pharmacy.
As an Alternative to the now-recalled drugs, other medicinal products the BfArM is that available. Patients should contact their doctor or pharmacist, advises the BfArM.
Only in the past year, NDMA and similar Compounds, called nitrosamines known to have been found in a number blood pressure. At that time, blood pressure-lowering drug with the active ingredient Valsartan, were recalled, hundreds of thousands of patients were affected.
As a reaction, health authorities are investigating, in the meantime, other medicines as a precautionary measure, nitrosamines, in the case of the controls, the ranitidine were containing medications.