The Spanish Agency of Medicines and Health Products ( Aemps) has ordered the withdrawal from the market , as a preventive measure, of 16 drugs containing ranitidine (active principle which is used to reduce the production of acid in the stomach) for the detection of a possible carcinogen .
last September 13, the Aemps reported the home, at a european level, a review of medications that contain ranitidine for the detection of N-Nitrosodimetilamina (NDMA) in some of them. In the framework of this review, we have analyzed batches of medicines containing this active principle, by detecting the presence of this impurity in a number of these lots.
For this reason, in Spain, the Aemps has ordered the removal of all the batches of ranitidine in tablets available in the market. Medicines, corresponding to 16 holders of marketing authorisation are listed in annex 1 of this briefing note.
The Aemps has adopted this withdrawal, which is being done also at european and international level, such as precaution and in order to reduce to a minimum the exposure to this substance.
drugs with ranitidine intravenous remain in the market and are not the subject of withdrawal, to be essential in some therapeutic indications, such as prevention of hypersensitivity and infusion-related reactions with paclitaxel and patisiran.
ranitidine is an active ingredient that is used to reduce the production of acid in the stomach in situations like the gastric ulcer or gastroesophageal reflux .
The 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 is not expected to cause no harm when ingested in very small quantities .
With the available data, there is no evidence that the presence of this substance has been able to produce any harm to patients who have consumed the drug. However, the potential risk derived from the cumulative effect of the above-mentioned impurity, makes necessary the adoption of precautionary measures to avoid their presence in medicines.
In any case it is justified that patients discontinue treatment with ranitidine without consult your doctor , because the risk of stop taking the medication is significantly greater than the risk of following him taking until the next consultation with your doctor.
The Aemps remember that are there in the market other medicines , with other active principles, that have the same therapeutic indications. For this reason, patients who take medications that contain ranitidine can consult your doctor to contemplate the possibility of changing to other medications. Among them are inhibitors of the proton pump such as omeprazole, pantoprazole or lansoprazole; the H2-receptor antagonists, such as famotidine.
These medications are removed:Updated Date: 02 October 2019, 19:00