GLAXOSMITHKLINE has issued a global recall for Zantac (ranitidine) over concerns about contamination with N-nitrosodimethylamine (NDMA), expanding an earlier alert which saw the drug pulled in Ireland, India and Hong Kong.
The Therapeutic Goods Administration (TGA) last week issued an update about the removal of several ranitidine-containing products from the Australian market, leading to shortages of tablets and oral liquids.
"Additional brands may be recalled as the TGA continues testing and discussions with companies that supply ranitidine," the TGA said.
Long-term exposure to NDMA, over a period of years, "can increase an individual's risk of developing cancer," according to the TGA, which notes that the risks from short-term use of ranitidine are expected to be extremely low.
Pharmacists providing advice to patients accessing ranitidine over the counter are being told to discuss treatment options and "review whether ongoing pharmacotherapy is appropriate".
The European Medicines Agency kicked off a review of ranitidine medications last month (PD 20 Sep), while other regulators including the US FDA have also raised concerns.
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