Many ranitidine products – including the Zantac brand – have been subject to a TGA recall notice following concerns about contamination with potentially carcinogen nitrosomamine .

The TGA is advising health professional to expect shortages of ranitidine products following their withdrawal from sale in pharmacies, hospitals, wholesalers, and other retail outlets, such as supermarkets.

“Doctors who are treating patients with ranitidine may need to consider alternative management, as oral dose forms of ranitidine are in short supply,” the regulator said in a statement published on 22 October.

It suggested patients be offered alternative management with another H2 receptor antagonist, proton pump inhibitors, and/or diet and lifestyle modification.

The TGA took the recall action after its laboratory testing of 135 sample batches of ranitidine products on the Australian market showed that 29 products were affected by  N‑nitrosodimethylamine (NDMA) impurities, as experienced in the USA.

It made the decision to recall all the 29 products found to that contain levels of NDMA above the internationally agreed limit of 0.3 parts per million (ppm), leaving only five on the market .

“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.

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.

Additional brands may be recalled as TGA continues testing and discussions with companies that supply ranitidine.

The affected products include:

• 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”).