Two forms of the anti-reflux drug Zantac are back on the Australian market, five years after being pulled off because of safety concerns.
The medication’s sponsor, Aspen Pharmacare Australia, has been working with the Therapeutic Goods Administration to ensure it met the requirements for safety and efficacy for inclusion on the Australian Register of Therapeutic Goods.
Zantac is a histamine-2 receptor antagonist (H2RA) over-the-counter medicine for the treatment of gastro-oesophageal reflux symptoms.
Both the 150mg tablets and Double Strength 300mg tablets (ranitidine as hydrochloride) have been reinstated. The 150mg tablets are for 12-hour relief from heartburn and acid indigestion, while the double strength tablets are for 24-hour relief of symptoms of gastro-oesophageal reflux.
In September 2019, the TGA removed all medicines containing ranitidine from the Australian market over concerns about the level of nitrosamine impurities in ranitidine products, specifically N-Nitrosodimethylamine (NDMA).
The FDA also requested manufacturers to withdraw all prescription and OTC ranitidine drugs from the market immediately in January 2020.
NDMA has been classified as a probable human carcinogen and concerningly, and the FDA determined that the impurity in some ranitidine products increased over time and may result in unacceptable levels of exposure if stored at higher than room temperatures.
As a result of the recall, Aspen Pharmacare Australia was exempt from annual charges in 2022-23, declaring $0 turnover in that period.
The medication will be available nationally in pharmacy and grocery outlets from this month, without a prescription, and are usually taken once or twice a day 30 to 60 minutes before eating or drinking foods that cause heartburn.
The company said it had worked with the TGA to show the drug was stable throughout its shelf life and that nitrosamines are controlled within internationally established acceptable intake limits applied to the maximum daily dose.
GPs should remind patients that OTC ranitidine may cause side effects including:
- headache
- constipation
- diarrhoea
- nausea
- vomiting
- stomach pain