The once popular anti reflux and heartburn drug, Zantac, will soon be available again in major Australian pharmacy and grocery outlets following its reinstatement on the Australian Register of Therapeutic Goods this month.
The TGA recalled the over-the-counter medication, also known by its generic name ranitidine, in October 2019 over concerns about the level of nitrosamine impurities in ranitidine products – specifically the carcinogen N-Nitrosodimethylamine (NDMA). The compounds are commonly found in low levels in a variety of foods, particularly smoked and cured meats, as well as in some drinking water and in air pollution. Long-term exposure, over years, can increase an individual’s risk of developing cancer, the TGA reports.
“The levels of NDMA contamination detected in ranitidine to date, if taken over decades, may modestly increase an individual’s risk of developing cancer,” the TGA said at the time.
But while acceptable levels have been derived from animal carcinogenicity studies and incorporate a wide margin of safety, it is not possible to provide an accurate number estimate of the magnitude of carcinogenic risk associated with NDMA contamination based on currently available safety data, it added.
“Health professionals can reassure patients that the additional risk posed by NDMA from ranitidine at the levels identified to date is very low. However, for patients who are currently taking ranitidine these risks may outweigh the clinical benefits,” it concluded.
Now, some five years on from the product disappearing from shelves, drug manufacturer Aspen Pharmacare Australia, the compan responsible for Zantac in Australia, says it has been working with the TGA to demonstrate that the medication is ‘stable throughout its shelf life and that nitrosamines are controlled within internationally established acceptable intake limits applied to the maximum daily dose’.
The company said the drug now meets all requirements for the inclusion of Zantac as a registered medicine on the ARTG.
Speaking to the limbic, Professor Andrew McLachlan AM, who is the Head of School and Dean of Pharmacy, Sydney Pharmacy School, Faculty of Medicine and Health at the University of Sydney said there are a number of factors that may contribute to an increase in nitrosamines in a product.
“These include formulation, quality of ingredients, manufacturing process, packaging and storage. All of these factors must be assessed and modified to ensure Zantac meets the internationally accepted quality standards. The makers of Zantac have now demonstrated to the TGA their ranitidine products meet these international requirements across its shelf-life to ensure these products are safe to use and now back on the Australian Register of Therapeutic Goods (ARTG).”
According to Professor McLachlan, physicians talking to patients seeking treatment for reflux symptoms can have confidence that Zantac products meet strict international limits for controlling n-nitroso compounds.
“These limits mean that these meet a high quality standard. Zantac medicines are indicated for short-term use and even if taken long term the risk of exposure to N-nitroso compounds is considered very low.”
The TGA has specified a list of conditions for ranitidine products to ensure that they do not contain unacceptable levels of NDMA.
‘The internationally agreed limits for NDMA are set so that an individual who takes a product over their life-time (70 years) will not increase their risk of cancer by more than 1 in 100,000, based on animal studies’, the TGA states on its website.
Zantac 150mg tablets are indicated for 12-hour relief and ZANTAC Double Strength 300mg tablets for 24-hour relief from heartburn and acid indigestion due to gastro-oesophageal reflux.
The medication will be available in October 2024 from major pharmacies and grocery outlets nationally, without a prescription.