EU-US concern over carcinogenicity in known stomach medicines – Investigations underway
Concerns in the US and European Union have raised the possibility of carcinogens in known and popular ranitidine-containing medicines.
Checks have shown that some of these medicinal products contain an admixture called N-nitrosodimethylamine (NDMA) and which is classified as a potential human carcinogen, based on animal studies.
Subsequently, both the European Medicines Agency (EMEA) and the US FDA are requesting a review of the ranitidine-containing drug product lines.
According to the European Medicines Agency (EMA), the investigation will be carried out following a commission mandated by the NDMA. This element is found even in food or in water, but is at very low levels, which do not appear to endanger human health.
The European Medicines Agency is therefore asked to assess whether patients taking ranitidine medicinal products are at any risk due to the NDMA component.
Which medicines include ranitidine
Ranitidine is an essential active ingredient used in formulations to fight heartburn and stomach ulcers, such as Zantac. The well-known medicine sold in the Greek market, even without a prescription, is based on this substance.
The European Medicines Agency recommends calm, and patients who receive regular treatment are advised to contact their doctor or pharmacist. There are several other marketed formulations that treat stomach problems and are based on an active ingredient other than ranitidine.
Sandoz, a subsidiary of Novartis, announced on Wednesday, September 18, that it is stopping the sale of its ranitidine-containing preparations, stating that it is “preventing distribution”. This practically means that it does not recall its products from points of sale and that existing medicines on the shelves of pharmacies can continue to be sold as normal.
Call for withdrawal of drugs in the US
As we read in American publications, an online pharmacy in the US invites citizens to an online collection of signatures to ban the sale of ranitidine on the US market.
The pharmacy in its public post claims that there are academic studies that prove that NDMA levels in a well-known stomach preparation go beyond the permissible limits set by the US Health Service.
The US authorities, however, say they have been made aware of the suspension of the pharmacy, but they can not easily accept his claims. “Although NDMA may be harmful in large quantities, the US Health Service found that ranitidine levels were just above the levels found in everyday foods,” the US authorities said.
Source – iefimerida.gr