The Spanish Agency for Medicines and Health Products (Aemps) has ordered the withdrawal of 16 medicines containing ranitidine (active ingredient used to reduce the production of acid in the stomach in cases of gastric ulcer or gastroesophageal reflux). the detection of a possible carcinogen. The measure, of a preventive nature, responds to the detection of nitrosamines, a substance classified as carcinogenic.
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.
NDMA is classified as a probable carcinogen in humans based on animal studies. It is present in some foods and in some water sources, but it is not likely to cause any damage when ingested in very small quantities.
In Spain, AEMPS has ordered the withdrawal of all batches of ranitidine in commercially available tablets, corresponding to 16 pharmaceutical companies. 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
Within this precautionary approach, "intravenous drugs remain on the market and are not subject to withdrawal, as they are essential in some therapeutic indications, such as the prevention of hypersensitivity and reactions related to infusion with paclitaxel and patisiran," reports Rosario from the river.
"With the available data, there is no evidence that the presence of this substance has been able to cause any harm to the patients who have consumed the medicine. However, the potential risk derived from the cumulative effect of said impurity makes it necessary to adopt precautionary measures to avoid its presence in medications, "explains the Aemps.
The Agency of the Medicine also remembers that the treatment is not interrupted without consulting with the doctor and informs that there are medicines in the market, with other active principles, that have the same therapeutic indications, among them, omeprazole, pantoprazole or lansoprazole, or the famotidine
Withdrawn medications can be found on the agency's website (www.aemps.gob.es)
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