Zantac is banned
Gastric drugs with ranitidine recalled, no acute risk to patients
The European Medicines Agency has recalled gastric acid blockers with potentially carcinogenic compounds. These are drugs with the active ingredient ranitidine, informed the Federal Office for Health Safety (BASG). Medicines containing ranitidine are used for heartburn, for the treatment of reflux disease and for the prophylaxis of gastric ulcers.
According to the BASG, there is no acute risk for patients. From today's perspective, there is also no acute need to dispose of an opened package, it said.
All batches of pharmaceuticals containing the active ingredient ranitidine produced by the manufacturer Saraca Laboratories Limited were recalled. There are indications that the active ingredient from other manufacturers could also be affected by the contamination. In Austria, according to the BASG, the following drugs are affected by possible contamination and are being recalled at pharmacy level:
- Ranitidine 1A Pharma 300 mg film-coated tablets
- Ranic Hexal 150 mg film-coated tablets
- Ranic Hexal 300 mg film-coated tablets
In this country, the currently approved drugs are only available on prescription.
Investigations revealed contamination with N-nitrosodimethylamine (NDMA), better known as nitrosamine. According to BASG, NDMA is classified as a likely carcinogenic substance for humans on the basis of animal experiments. It's also found in small amounts in some foods and water supplies, but NDMA isn't expected to cause harm if ingested in very small amounts, according to the BASG.
Patients who have concerns about the therapy based on the available findings should contact a doctor or pharmacist. Other drugs and alternatives are also approved for the same treatment areas as ranitidine, the BASG informed.
NDMA and related substances were found in some blood pressure drugs (also known as angiotensin II receptor blockers or "sartans") in 2018. This led to recalls across Europe and subsequently to strict new requirements for the manufacture of sartan-containing drugs. As a consequence, health authorities around the world are also examining other drugs as a precaution for nitrosamines, including drugs containing ranitidine.
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