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By Nabeel Ibrahim Published on 14/09/2019

Zantac contains low levels of Cancer-causing impurity – FDA

This medicine contains low levels of NDMA, yet no recalls have been made so far.
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Nabeel Ibrahim

Published on: 14/09/2019

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The US Food and Drug Administration (FDA) released a statement alerting patients and professionals about a cancer-causing agent found in samples of Ranitidine.

Ranitidine, is sold under the trade name Zantac (among other names). It is a histamine-2 blocker, which means that it reduces the amount of acid produced by cells in the lining of the stomach. Zantac is an over-the-counter drug used to treat heartburns, and the prescription version is used in the treatment of stomach and intestine ulcers, and for the treatment of gastroesophageal reflux disease.

FDA states that some ranitidine medicines such as Zantac contains an impurity called NDMA at low levels. NDMA is recognized as a probable human carcinogen and is also found in water and foods including meats, dairy products and vegetables.

Moreover, FDA states that people don’t need to stop taking this medication, as the levels of NDMA found are low. Patients wishing to stop this medication should consult with their doctors first. They also advise people taking the over-the-counter version to switch to a substitute.

NDMA is dangerous in large amounts, but the levels found by FDA in ranitidine were low.

No recalls have been made so far by the FDA nor the company producing Zantac. A spokesperson for the company Sanofi stated that they take patient safety seriously and are committed to working with the FDA. The spokesperson also mentioned that the OTC Zantac has been around for over a decade, and meets the requirements for use.

Last year, NDMA was found in many brands of blood pressure and heart failure medicines. This led to recalls.

According to FDA, they are still evaluating this issue and will post the information when possible.

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