Ranitidine: Still Under The Scanner Of International Regulat
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Ranitidine is not to be completely discarded yet, says international regulatory authorities such as USFDA, MHRA, European Medicine Agency & DCG, India. "The recall of the drug is just a precautionary measure due to possible contamination of the active substance in Zantac, ranitidine, with an impurity called NDMA". Medicines and Healthcare products Regulatory Agency, UK quoted in a recent press release discussing about Teva UK Ltd recalling unexpired stock of certain batches of 2 types of Ranitidine medicines.

Being at the center of the biggest pharmacological controversy ever, Ranitidine has been under the skeptical glance of several national as well as international regulatory committees ever since the U.S. Food and Drug Administration learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels, which is believed to be a probable human carcinogen.

Amidst the chaos surrounding Ranitidine, no international
regulatory agency anywhere has yet asked to stop using ranitidine. The European Medicine Agency is evaluating the data to assess whether patients using ranitidine are at any risk from NDMA and will provide information about this as soon as it is available.

The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition.

In India also, The Directorate General of Health Services, DCG(I) has informed all state /UT drug controllers to ask all API and formulation manufactures under their jurisdiction to verify their products and take appropriate measures to ensure patient safety.

FDA does not have scientific evidence to recommend whether individuals should continue or stop taking Ranitidine medicines at this time. The agency is conducting further tests to determine the risk to consumers.

Source: https://www.fda.gov/news-events/press-announcements/statement-alerting-patients-and-health-care-professionals-ndma-found-samples-ranitidine
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Dr. D●●●●●i V●●●●●h
Dr. D●●●●●i V●●●●●h Dentistry
Thank you for ranitidine latest info for our referrence.
Oct 26, 2019Like2
Dr. J●●a J●●n
Dr. J●●a J●●n Biochemistry
Thanks for the update
Oct 30, 2019Like