Drugs for heartburn and indigestion will disappear from pharmacies? Not all of them, but we won’t buy popular ranitidine products anymore. Their sale has been suspended by the European Medicines Agency for Medicinal Products for Human Use. Why? What are the patients who have been taking so far to use ranitidine to do?
Contamination was detected in drugs with ranitidine
The Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP) on April 30, 2020 recommended the suspension of all ranitidine medicines in the European Union. The reason for this decision is the detection of a low level of N-nitrosodimethylamine (NDMA) contamination. The activity of this compound has been classified as potentially carcinogenic and biotoxic.
- Read also: What does it mean if the drug is contaminated?
Ranitidine is an active substance that blocks the connection of histamine with histamine H2 receptors, found, for example, in the stomach. Drugs with ranitidine lower stomach acid levels. They are used to treat patients with diseases such as stomach ulcers, reflux oesophagitis and heartburn.
– The ranitidine product review was initiated on September 12, 2019 at the request of the European Commission under Art. 31 of Directive 2001/83 / EC. The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions on medicines for human use, which adopted the opinion of the Agency. The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision in force in all EU Member States – a spokeswoman for the Main Pharmaceutical Inspectorate (GIF) submitted to Medonet.
– GIF, after receiving information about the possible presence of contamination in products with ranitidine, on September 19, 2019, suspended all medicinal products containing ranitidine as an active substance on the territory of Poland. These products were withdrawn from the market in the following months. Now no ranitidine-containing products are available for sale in Poland The spokeswoman added.
Ranitydyna Aurovitas, Solvertyl, Riflux, Ranimax Teva, Ranigast, Ranigast Pro, Ranigast Fast, Ranigast Max, Raniberl Max, Ranic
People who have been taking medications with ranitidine are advised to contact their doctor or pharmacist for an alternative treatment option.
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