SANOFI PULLS ZANTAC AFTER CARCINOGEN FOUND
NEW York—sanofi SA said on Friday it would recall popular heartburn medicine Zantac in the United States and Canada, after the medicines were linked with a probable cancer-causing impurity.
The French drugmaker said it was working with health authorities to determine the level and extent of the recall, which it called a precautionary measure being taken due to possible contamination with a substance called N-nitrosodimethylamine (NDMA).
Sanofi has sold over-thecounter Zantac in the United States and Canada since 2017. It is pulling the drug off shelves after previous recalls by some manufacturers of generic versions of the drug.
Sanofi reported Zantac sales of 127 million euros in 2018 and 69 million euros over the first IMPURE? Zantac heartburn pills. half of 2019.
US and European health regulators said last month they were reviewing the safety of ranitidine, which is commonly sold as Zantac and its generic alternatives, after an online pharmacy called Valisure notified them that it had found impurities in the drugs.
The US Food and Drug Administration said earlier this month it found unacceptable levels of NDMA in drugs containing ranitidine. The regulator asked ranitidine makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency.
Sanofi CEO Paul Hudson, earlier this week, downplayed concerns about the drug.
“We don’t believe there’s a risk,” Hudson said on Tuesday.
“But we have to—and are appropriately duty bound to—satisfy the regulators, which we will do and we’ll move on from there.”
Other drugmakers including Glaxosmithkline and Novartis have recalled or halted distribution of their versions of the drug.