Zantac Recalls Expected After Carcinogen Found In Testing
Voluntary recalls of popular heartburn medication Zantac are expected to be announced on Monday over cancer fears, the TGA said, after traces of a known carcinogen were found in some products.
Preliminary testing by the Therapeutic Goods Administration found 40 ranitidine products (the active ingredient in Zantac) out of 44 tested positive for the carcinogen N-nitrosodimethylamine (NDMA).
The TGA said the results were "of concern", and that widespread recalls are "quite possible". It wrote to all 11 Australian suppliers and manufacturers of raniditine products last week, requesting urgent information about their batches of products currently in the market.
"Several major suppliers are expected to announce voluntary recall actions before COB Monday," a TGA spokesperson told 10 daily.
"These recalls plus the one already in progress by Sandoz Australia will now cover the vast majority of stock in the market."
10 daily has contacted Aspen Pharmacare Australia, Zantac Australia's parent company, for comment.
On September 17, the TGA announced some RANITIDINE and Mylanta products were being recalled after "Sandoz Australia were made aware that in two batches of their ranitidine product tested by Swissmedic – NDMA was identified."
"These particular batches have not been supplied to the Australian market, however, further testing revealed Australian supplied product is affected," the TGA said in its recall warning.
"As a precautionary measure, Sandoz is undertaking a Retail Level Recall whilst a full investigation is undertaken and the necessary corrective actions can be put in place."
Recalls are already underway in the United States, after the Food and Drug Administration found NDMA levels in heartburn medications.
CVS Health, one of the largest pharmacy chains in the US, announced this week it would suspend sales of ranitidine out of "an abundance of caution" following FDA testing.
"The levels that FDA is finding in ranitidine from preliminary tests barely exceed amounts found in common foods," it said in a statement.
"Zantac brand products and CVS brand ranitidine products have not been recalled, and the FDA is not recommending that patients stop taking ranitidine at this time."
NDMA, a chemical product used to create cancer in rats for research purposes, is found in very low levels in water and foods, including some smoked or cured meat, fish and vegetables.
The TGA will conduct "much more testing" and will contact each company individually next week.
"With lab results and new recalls confirmed this coming week, the TGA will follow up with the remaining sponsors, and determine what further action is appropriate on a case by case basis," the spokesperson said.
State and territory recall coordinators have been alerted.
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