SA pill regulator probes heartburn meds for potential cancer-causing impurities

The SA Health Products Regulatory Authority (SAHPRA) is investigating if ranitidine, a common heartburn medicine, has a chemical contamination which could cause cancer.
The SA Health Products Regulatory Authority (SAHPRA) is investigating if ranitidine, a common heartburn medicine, has a chemical contamination which could cause cancer.
Image: File photo.

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 American Food and Drug Authority (FDA) a week ago issued a warning that it had found an impurity, N-nitrosodimethylamine (NDMA), in some generic and original versions of ranitidine.

NDMA can be cancer-causing.

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 the levels it found in the drugs are low, similar to that in foods like processed or grilled meat that could contain them. It can be found in burnt toast and burnt braai 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."

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. SAHPRA cautioned patients who had been prescribed Ranititide from stopping without an alternative.

It said in a statement: "SAHPRA is urgently liaising with the registered suppliers of ranitidine-containing medicines to investigate the presence of NDMA in South African ranitidine products; and will update the public on the outcome of these investigations."

SAHPRA advised patients to speak to their healthcare professional before they stop or switch to other medicines that are approved for similar indications.

The European Medicines Agency is also looking into the matter, it said this week.

"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."

There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.

The European Medicines Agency said the chemical is present in some foods and in water supplies but is not expected to cause harm when ingested in very low levels.

This is not the first contamination.

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.

Many of these drugs were recalled in South Africa and abroad.

It is not clear how long they have been in medicines and how long people have been exposed.

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


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