The European Medicines Agency has recalled certain gastric acid blockers with potentially carcinogenic compounds. These are drugs with the active ingredient ranitidine , as the Federal Institute for Drugs and Medical Devices (BfArM) announced.
Ranitidine-containing medicines are used in heartburn, for the treatment of a so-called reflux disease and for the prophylaxis of gastric ulcers. "There is no acute patient risk," it said at the same time.
Accordingly, all batches of medicinal products containing ranitidine, manufactured by Saraca Laboratories Limited, were recalled. There are indications that the active ingredient of other manufacturers could also be affected by the contamination.
A list of the medicines affected so far can be found at the Federal Association of German Pharmacy Associations (ABDA) under this link, it is constantly updated.
Preventive health protection
It is about impurities with so-called N-nitrosodimethylamine (NDMA), better known as nitrosamine, reports the BfArM. The World Health Organization (WHO) International Agency for Research on Cancer classifies the substance as likely to cause cancer. "With a recording of very small quantities no harmful effect is to be expected," writes the Federal Institute.
So far, it is not known for all ranitidine-containing medicines whether and in what concentrations they contain contamination. The recall therefore takes place for reasons of preventive health protection. The potential hazard potential is currently being scientifically evaluated at the European level, said the BfArM.
Stomach acid blocker: drug for millions
In Germany, millions of people swallow gastric acid blockers, so-called proton pump inhibitors. They are either available by prescription or are sold directly to the pharmacy with lower levels of active ingredient without prescription.
As an alternative to the drugs now being recalled, the BfArM claims that other medicines are available. Patients should contact their doctor or pharmacist with questions, the BfArM advises.
Just last year, NDMA and similar compounds known as nitrosamines were found in a number of blood pressure medicines. At that time, antihypertensives were recalled with the active ingredient valsartan, hundreds of thousands of patients were affected.
In response, health authorities are now also investigating other drugs as a precautionary measure to nitrosamines, in the controls ranitidine-containing drugs.