- CVS Pharmacy will stop selling Zantac, a commonly used heartburn relief drug, "out of an abundance of caution" while U.S. regulators investigate contamination of a probable human carcinogen, the drugstore chain said Saturday.
- The Food and Drug Administration first alerted patients and healthcare professionals on Sept. 13 that preliminary tests of ranitidine samples found low levels of NDMA, or nitrosodimethylamine. In the weeks since, Novartis' Sandoz unit and Apotex, a manufacturer of generic versions for Walgreens, Walmart and Rite-Aid, have begun voluntary recalls.
- CVS will go a step further by halting all Zantac sales, including Sanofi's branded version and CVS Health's generic version. Sanofi has no plans to stop distributing or manufacturing Zantac outside of Canada, a company spokesperson stated in an email to BioPharma Dive.
Starting last summer, carcinogen concerns led to drug recalls for another type of heart medicine called angiotensin II receptor blockers, or ARBs, including valsartan, irbesartan and losartan.
Now, low levels of NDMA have led several drugmakers to start recalling Zantac as well.
Despite the contamination detected, FDA leaders have emphasized the minimal risk to patients in both cases and have not advised patients to stop taking ARBs or ranitidine.
"Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in the Sept. 13 statement.
Even with those caveats, Sandoz started a voluntary recall on Sept. 23 of its generic ranitidine capsules. On Sept. 26, Apotex issued its own recall for over-the-counter ranitidine labeled by Walgreens, Walmart and Rite-Aid.
Meanwhile, the FDA recently posted a method for testing ranitidine for NDMA and is working with manufacturers.
"FDA has asked ranitidine manufacturers to conduct laboratory testing to examine levels of NDMA in ranitidine and to send samples of ranitidine to the agency to be tested by our scientists," the agency stated.
Sanofi has been selling over-the-counter Zantac since 2017, when it finalized a deal for Boehringer Ingelheim's consumer healthcare business.
"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," the Sanofi spokesperson wrote, saying the company will publicly share further updates when available.