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Ulcer drug found to have cancer impurity

By Graham Kajilwa | September 16th 2019 at 12:00:00 GMT +0300

FDA however, in its findings, said the amounts of NDMA found in the drug were at low levels.

Health & Science
FDA however, in its findings, said the amounts of NDMA found in the drug were at low levels.

Ranitidine, a drug used to treat heartburn, has been flagged as containing cancer-causing agents. 

The US Good and Drug Authority (FDA) said the drug, which goes by the brand name Zantac, contains nitrosamine.

Nitrosamine, otherwise called N-nitrosodimeyhylamine (NDMA), is an impurity that has been found to be human carcinogen, a cancer-causing agent.

FDA however, in its findings, said the amounts of NDMA found in the drug were at low levels. 

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"NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables," read the statement from NDMA.

Zantac is an over-the-counter drug, which can be bought with or without prescription. It basically works by reducing the amount of acid produced in the stomach and therefore relieving heartburn. 

It is dispensed as syrup and tablets of 150mg.

"Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease," notes FDA.

FDA said it had been investigating NDMA and other nitrosamine-related impurities in blood pressure and heart failure medicines known as Angiotensin II Receptor Blockers(ARB) since 2018. "In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines," said FDA.

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In its update dated September 13, 2019, FDA said the revelation of the carcinogenic substance on the drugs should not warrant one to stop taking the drug. 

"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 options," read the statement.

The authority said people taking over the counter ranitidine could consider using other medicines approved for their condition. "There are multiple drugs on the market that are approved for the same or similar uses as ranitidine," said FDA.

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