The US Food and Drug Administration has warned of the dangers of using the Ranitidine drug. The tablets contain an admixture that can cause cancer.
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The U.S. Food and Drug Administration has warned healthcare providers and patients to voluntarily withdraw 14 batches of prescription ranitidine tablets distributed by Sandoz Inc., which are used to reduce the amount of acid released by the stomach.
The ban on the drug is caused by the fact that N-nitrosodimethylamine (NDMA) impurities were found in the composition of the drugs.
NDMA is classified as a probable carcinogen in humans (a substance that can cause cancer).
The European Directorate for the Quality of Medicines for Health (EDQM) on September 23, 2019 suspended the certificate for ranitidine hydrochloride. Against this background, drugs were withdrawn in Germany, Switzerland, Finland, Croatia, the Czech Republic, Hungary, Denmark, Canada, Italy, Spain, Poland, Portugal, Slovenia and Singapore.
Ranitidine includes an impurity that is a carcinogen / Photo: Unsplash
Therefore, manufacturers of drugs that manufacture drugs using the substance “ranitidine hydrochloride” manufactured by Saraka Laboratories Limited (India) and importing organizations of drugs released using this substance must provide information on the decisions taken by 02.10.2019 the framework of such a pharmaceutical substance and medicinal products made from it,
– the document says.
In general, 561 series of finished drugs have been recalled at the moment.
Patients taking this drug are advised to consult a doctor to select another drug. At the moment, there are more modern and safer drugs.
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