The Therapeutic Goods Administration (TGA) has released an update into the recall of heartburn and indigestion medication.
It is advising consumers and health professionals that several ranitidine containing products have been removed from the Australian market due to contamination with an impurity called Nnitrosodimethylamine (NDMA).
NDMA is a type of N-nitroso compound. N-nitroso 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.
Ranitidine, which is marketed in Australia under the brand name Zantac and various generic brands, is used to reduce stomach acid and is commonly used to treat heartburn. It may also be prescribed by a doctor to treat and prevent heartburn, reflux and ulcers.
Ranitidine is available in Australia as a prescription medicine and can also be purchased without a prescription from pharmacies, supermarkets and other retailers.
The tablets and oral liquids are now in short supply as a number of commonly-used brands have been recalled from pharmacies, hospitals, wholesalers, and other retail outlets, such as supermarkets and online stores.
Although the additional risk posed by NDMA from ranitidine is considered to be very low, such contamination is considered unacceptable for a medicine.
Health risks depend on dose and will vary from person to person. The risks from short-term use of ranitidine are expected to be extremely low and the main risk is associated with long-term use.
The TGA has been investigating NDMA and other N-nitroso compounds that have been found in 'sartan' blood pressure medicines since 2018.
People who use ranitidine may need to switch to alternative therapies because there is a shortage of ranitidine tablets and oral liquids due to the recalls.
There are other medicines available to treat heartburn, ulcers and reflux, including prescription medicines and products that can be purchased without a prescription from pharmacies, supermarkets and other retailers.
People who are taking ranitidine without a prescription should speak to their pharmacist about their treatment options.
But patients are reminded that people who have been prescribed ranitidine, the risks of not treating their condition may pose a greater risk to health than the potential contamination with NDMA. These people should speak to their doctor about an alternative treatment.
For pregnant women, the risks to the foetus associated with use in pregnancy of ranitidine contaminated with NDMA, at the levels observed to date, are expected to be very low. But consideration should be given to alternative treatments while the issue is being investigated.
Additional brands may be recalled as TGA continues testing and discussions with companies that supply ranitidine.
The TGA will publish a detailed testing report when the testing has been completed.
- Sandoz ranitidine (marketed under the brand names 'Sandoz Ranitidine' and 'Mylanta Ranitidine')
- Aspen ranitidine (marketed under the brand name 'Zantac')
- Alphapharm ranitidine (marketed under the brand name 'RANI 2')
- Apotex ranitidine (marketed under the brand names 'APO', 'CHEMMART', 'TERRY WHITE CHEMISTS' and 'APOHEALTH')
- Symbion ranitidine (marketed under the brand names 'Pharmacy Choice Acid and Heartburn Relief'/'Extra Strength')
- Cipla Australia ranitidine (marketed under the brand names 'AMCAL' and 'Pharmacy Care')
- Generic Health ranitidine (marketed under the brand name 'Pharmacy Action').
- Nova Pharmaceuticals Australasia ranitidine (marketed under the brand names 'Coles (and) Medix Heartburn & Acid Indigestion').
- Australian Pharmaceutical Industries Ltd t/a Soul Pattinson Manufacturing ranitidine (marketed under the brand names 'Pharmacy Health (and) Priceline Pharmacy Reflux Relief Extra Strength Ranitidine' and 'Terrywhite Chemmart Heartburn Relief Extra Strength Ranitidine')
- Arrow Pharma ranitidine (marketed under the brand names 'AUSRAN Ranitidine', 'CHEMIST'S OWN RANITIDINE FORTE' and 'CHEMIST'S OWN RANITIDINE'). While all batches of the previous nine sponsor's products are being recalled, following TGA testing, only some batches of Arrow Pharma ranitidine are being recalled.