• Alert: Sanidad withdraws 16 medications with ranitidine for detecting a possible carcinogen

The Spanish Agency for Medicines and Health Products (Aemps) has ordered the withdrawal of 16 medicines containing ranitidine after having detected the presence of nitrosamines in them, a substance cataloged as probably carcinogenic.

What is ranitidine?

It is a drug that is used to reduce the production of acid in the stomach in cases of gastric ulcer or gastroesophageal reflux , among others (it is often prescribed, for example, to treat the burning and reflux that is sometimes associated with pregnancy) . It belongs to a group of medications called histamine H2 receptor antagonists. In Spain it is sold under presentations such as Alquen , Ardoral or Zantac , among others.

Why has your withdrawal been ordered?

It is a precautionary measure. In drugs containing ranitidine, the presence of nitrosamines has been detected, a substance that has been classified as a probable carcinogen in humans (group 2A) by the International Agency for Research on Cancer. Nitrosamines are also present in food and some water sources and are not likely to cause any damage when ingested in very small amounts, Aemps has warned.

Are there affected patients?

According to the Aemps, there is no evidence that this substance has caused damage to patients who have consumed the medication. However, given "the potential risk derived from the cumulative effect of the aforementioned impurity," it has been decided to adopt "precautionary measures to avoid its presence in medicines," Aemps said in a statement.

Why are there nitrosamines in the drugs?

These impurities that have been detected are of the same type of substances that caused, in 2018, the withdrawal of different medications for high blood pressure, such as valsartan. Impurities were generated as a result of a change in the manufacturing process of the active ingredient, which altered the final result. On September 13, Aemps, under the Ministry of Health, reported the start, at European level, of a review of drugs containing ranitidine (indicated for gastric ulcer or gastroesophageal reflux) for the detection of N-Nitrosodimethylamine (NDMA) In some of them.

Should I stop taking the medication?

Health authorities have recalled that treatment should not be interrupted without first consulting with a professional. In the market there are drugs with the same indication, such as omeprazole , pantoprazole or famotidine. On the other hand, as indicated by Health, intravenous drugs that contain the active substance will remain on the market, "being essential in some therapeutic indications, such as the prevention of hypersensitivity" and some reactions.

Which laboratories are affected by the withdrawal?

The affected laboratories are the following: Smithkline Beecham Farma, SA, Laboratorios Cinfa, SA, Laboratorios Normon, SA, Glaxosmithkline, SA, Laboratorios Alter, SA, Apotex, Aristo Pharma Iberia, SL, Aurovitas Spain, SAU, Laboratorios Francisco Durban, SA , Mabo-Farma, SA, Mylan Pharmaceuticals, SL, Pensa Pharma, SAU, Ratiopharm España, SA, Teva Pharma SL, Industria Química Y Farma Farmaica Vir, SA and Kern Pharma, SL

According to the criteria of The Trust Project

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