The TGA has issued new advice for consumers about ranitidine, following the recent recall
Earlier this month it recalled a number of brands of the heartburn medication, including Aspen’s Zantac, as there had been contamination with an impurity called N‑nitrosodimethylamine (NDMA).
It is now advising that it has tested 135 different batches of medicines containing ranitidine, and that 75% of the medicines have been found to contain heightened 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.
However, the risk to consumers remains small, it says.
“If you were to take a ranitidine tablet every day of your life for 70 years, then you would have an increased cancer risk of about one in 100,000,” the TGA has advised.
However, this increased risk is considered unacceptable for a medicine.
“The actual 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.”
“But if you have painful or persistent heartburn, you still need relief. Your doctor or pharmacist can advise you on whether to continue with a ranitidine product, try an alternative medication, or explore lifestyle changes to better manage your heartburn.”
Now that some ranitidine products are not available, a shortage is expected to continue in Australia until mid next year.
“We are working with international regulators and companies on this issue to ensure that heartburn products that contain ranitidine are safe and effective,” the TGA says.
“Pharmacists who are providing advice to patients accessing ranitidine over the counter should discuss treatment options and review whether ongoing pharmacotherapy is appropriate.
“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.”
The TGA says it is continuing to work with international regulators and medicine sponsors to investigate the issue.