NEW YORK — CVS Pharmacy cease sales of heartburn drug Zantac and its generic, ranitidine, due to a recent FDA alert tying the drug to a “probable human carcinogen,” CVS said in a statement.
The company announced the decision Saturday, saying they’ll stop selling all Zantac brand and CVS Health brand ranitidine products until further notice as the FDA evaluates whether or not low levels of nitrosodimethylamine — or NDMA — pose a risk to patients.
The US Food and Drug Administration said earlier this month that it has learned that some ranitidine — the acid-reducing and heartburn medicines, including those known by the brand name Zantac — contain low levels of an impurity that could cause cancer.
The nitrosamine impurity, 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.
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.
A study published last year in the medical journal BMJ found no “markedly increased short term overall risk of cancer” among users of the valsartan drugs contaminated with NDMA. Yet that study also noted that research into long-term cancer risk is needed.
The drugs have not been recalled, and the FDA does not recommend patients stop taking it at this time. However, customers who purchased the products can return them to CVS stores for a refund, the company said.
Ranitidine is an over-the-counter and prescription histamine-2 blocker, which decreases the amount of stomach acid.
Drugmaker Novartis said it is halting distribution of all ranitidine medicines made by Sandoz, a measure it called “precautionary” after the acid-reducing medications were found to contain an impurity.
“A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the USA. Our internal investigation is ongoing to determine further details. In case of concerns, adequate additional measures will be implemented in alignment with relevant Health Authorities as required,” Novartis said in a emailed statement.
Drugmaker Sanofi, which makes ranitidine medication sold under the brand name Zantac, said in a statement emailed on Thursday that it currently has “no plans to stop distributing or manufacturing Zantac or other ranitidine products outside of Canada.”
People can report adverse health reactions with ranitidine to the FDA’s MedWatch.