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SA regulator joins worldwide investigation into heartburn medication

The SA Health Products Regulatory Authority (SAHPRA) is investigating if ranitidine, a common heartburn medicine, has a chemical contamination which could cause cancer. The drug is also known as Zantac, Ultak, Austac and R-Lok.

The Times reports that this was after the US Food and Drug Authority (FDA) issued a warning that it had found an impurity, N-nitrosodimethylamine (NDMA), in some generic and original versions of ranitidine. However, it cautioned that levels of the chemical appeared low and not much higher than when the chemical is present in foods like processed or grilled meat.

The FDA said: "Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods."

The report says over-the-counter ranitidine is approved to prevent and relieve heartburn and can be prescribed to prevent ulcers of the stomach and intestines. Both SAHPRA and the FDA told people they could still keep taking the medicine or ask doctors to prescribe one of many drugs that treat heartburn or ulcers.

The European Medicines Agency is also looking into the matter, says a Sowetan report. "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 healthcare professional about other treatment options."

The report says this was not the first time that contamination had been investigated. In 2018, these chemical and compounds known as nitrosamines were found in a number of blood pressure medicines known as "sartans", leading to some recalls and to an EU review, which set strict new manufacturing requirements for these medicines. They are believed to come from the manufacturing process. The report says many of these drugs were recalled in South Africa and abroad.

The international agencies are currently working on how to ensure avoid presence of nitrosamines in other classes of medicines.

[link url="https://www.timeslive.co.za/news/south-africa/2019-09-20-sa-pill-regulator-investigating-heartburn-meds-for-potential-cancer-causing-impurities/"]The Times report[/link]

[link url="https://www.sowetanlive.co.za/news/south-africa/2019-09-20-sa-pill-regulator-probes-heartburn-meds-for-potential-cancer-causing-impurities/"]Sowetan report[/link]

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