TheAIFA, the Italian Medicines Agency, has published an important update on the story of antacid drugs against stomach acid and gastroesophageal reflux: it has ordered a ban on the use of 516 batches of medicines (here the complete list) containing the active substance of ranitidine produced by the Indian Saraca Laboratories. The reason? The substance would be present N-nitrosodimethylamine (NDMA) likely Cancer for man.
The new update concerns a list of lots for which the use ban has been foreseen - that is the doctor must not prescribe them, the pharmacist must not sell them, the patient must not take them pending that on lots theHigher Institute of Health do the due analysis to verify the presence of NDMA - yes adds to the list of drugs, 197 lots, for which instead the 20 September 2019 (here the list of lots withdrawn) Aifa has arranged for the withdrawal from the market and which therefore are presumed to be no longer for sale or prescription.
What to do in case of doubt?
In case of doubt, Aifa itself recommends contact your doctor e:
- If you are being treated with a ranitidine medicine that has been prescribed by your doctor, do not stop treatment, but consult your doctor as soon as possible. You can agree with him on an alternative treatment (another medicine other than ranitidine, indicated in the treatment of conditions in which the stomach produces excessive amounts of acid).
- Sand you are being treated with a ranitidine self-medication, consult your doctor or pharmacist who will be able to recommend an alternative medicine.
- NDMA is an organic chemical that is generated as a by-product of numerous industrial processes. It is also present at very low levels in water supplies and in some foods, especially those cooked, smoked or seasoned. No damage is expected when ingested in very low quantities.
- No acute risk is expected for the patient who has already taken medicines containing ranitidine.
In case of doubt, it is also advisable to check both the lists communicated by Aifa, which can be consulted here:
- List of 197 lots RETIRED
- List of 516 lots on which there is PROHIBITION OF USE