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Recall for Heartburn Remedies for Carcinogenic Substance

Recall for Heartburn Remedies for Carcinogenic Substance


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Carcinogenic substance: gastric acid blockers are recalled

Medicines are being recalled in the European Union to control gastric acid production in heartburn, to treat reflux disease and to prevent stomach ulcers. Traces of the nitrosamine N-nitrosodimethylamine (NDMA) have been detected in the ranitine-containing medicinal products. This substance is classified as likely to be carcinogenic in humans.

There was a recall for hypertension medications last year because they were contaminated with N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA). Medicines are now being recalled because traces of the dangerous substance have been detected. Medications for heartburn are now affected.

Contamination of drugs containing ranitidine was found

As reported by the Federal Institute for Drugs and Medical Devices (BfArM) in a communication, the European Medicines Agency (EMA) has initiated a review of ranitidine-containing medicines at the request of the European Commission after tests have shown that some of these products contain the contaminant N-nitrosodimethylamine ( NDMA) included.

The BfArM also informs on its website that medicinal products containing the active substance ranitidine manufactured by the active substance manufacturer Saraca Laboratories Limited are being recalled in the European Union. According to the information, there are indications that the active ingredient of other active ingredient manufacturers could also be affected by the contamination.

Ranitidine medicines are used to control gastric acid production in heartburn, to treat reflux diseases and to prevent gastric ulcers. These drugs are available both over the counter and with a prescription.

Substance is classified as likely to cause cancer in humans

According to the BfArM, since the European risk minimization measures for sartans, which are intended to prevent nitrosamine exposure by these hypotensive agents, other medicinal products have been tested worldwide for preventive purposes by the health authorities for nitrosamines.

In this context, small amounts / traces of the nitrosamine N-nitrosodimethylamine (NDMA) have now been detected in drugs containing ranitidine. "This substance is classified by the international cancer research agency of the WHO and the EU as likely to be carcinogenic in humans," write the experts.

Recall for preventive health protection

According to the Federal Institute, concrete information is not yet available on all ranitidine-containing medicinal products as to whether and in what concentrations the contaminant is contained. Therefore, all batches with active ingredient from the manufacturer Saraca Laboratories Limited are recalled for reasons of preventive health protection until the matter is clarified.

A scientific assessment of the potential risk is currently being carried out at European level. "The aim is to take harmonized measures to protect patients at short notice across Europe," says the BfArM.

Patients who have questions about their current treatment can contact their doctor or pharmacist. There are various medications that can be used in the same indication area as ranitidine as alternatives. There is no acute patient risk. (ad)

Author and source information

This text corresponds to the specifications of the medical literature, medical guidelines and current studies and has been checked by medical doctors.



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