CVS Pharmacy has stopped selling Zantac, as well as its generic version of the heartburn medication, over concerns that they might contain a substance that could cause cancer.
CVS, the largest pharmacy chain in the country, said over the weekend it was suspending sale of Zantac and other products which contain ranitidine until further notice. The US Food and Drug Administration said earlier this month that it has learned that some ranitidine — acid-reducing and heartburn medicines, including those known by the brand name Zantac — contain low levels of an impurity that could cause cancer.
Zantac and its generic counterpart have not been recalled, a statement from CVS said, and the FDA has not recommended that patients stop taking ranitidine products.
The nitrosamine impurity known as N-nitrosodimethylamine, or NDMA, has been classified as a probable human carcinogen based on lab tests, and this isn’t the first time that it has been detected in a common medication.
The FDA has the complete list of recalled products here. Earlier this week, Novartis-owned Sandoz recalled 30-count, 50-count and 500-count bottles of prescription ranitidine capsules, and overseas, British drugmaker GlaxoSmithKline is also recalling ranitidine products in India and Hong Kong (it does not sell versions of the drug in the US). Several countries are taking steps to restrict sales of drugs containing ranitidine , ABC News reports.
The FDA is testing Zantac and its generic versions, but has not yet asked drugmakers for a recall. And Sanofi, which produces the brand-name Zantac, is…
…not yet making any moves.
“The FDA reported that the levels of N-nitrosodimethylamine (NDMA) in ranitidine in preliminary tests barely exceed amounts found in common foods,” says a Sanofi spokesperson. “We are working closely with the FDA and are conducting our own robust investigations to ensure we continue to meet the highest quality safety and quality standards.”
NDMA and two other cancer-causing substances have also led to widespread recalls of blood pressure and heart medications since last year. Manufacturing flaws were blamed for that, but in this case, experts say it’s likely that enzymes in a person’s body react with the ranitidine molecule and actually create NDMA.
Since last year, the FDA has been investigating NDMA and other impurities in blood pressure and heart failure medicines known as angiotensin receptor blockers or ARBs. Numerous recalls have been launched as the FDA found “unacceptable levels” of nitrosamines in several of those common drugs containing valsartan.
Customers who have already bought the products can return them to CVS for a refund, CVS said.
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