Zantac and some OTC meds found to contain suspected carcinogen first discovered in blood pressure drugs

The safety scare over possible cancer-causing impurities in blood pressure meds has now spread to ranitidine drugs, including Sanofi's Zantac and generic and over-the-counter versions of the popular heartburn medicine. (Sanofi)

The saga of potentially dangerous impurities in the U.S. drug supply continues. A suspected cancer-causing impurity that has been found in some blood pressure medicines has now shown up in Sanofi's Zantac and some over-the-counter heartburn drugs. 

At this point, the FDA says that while N-nitrosodimethylamine (NDMA) has been discovered in these ranitidine medicines like Zantac, the risks are still unknown.  

The FDA says it is working with regulators globally to determine the source of the tainted ingredient and has yet to determine whether the amount of the impurity in the drugs poses any kind of serious risk to consumers; the agency said it appears to be small.


Simplify and Accelerate Drug R&D With the MarkLogic Data Hub Service for Pharma R&D

Researchers are often unable to access the information they need. And, even when data does get consolidated, researchers find it difficult to sift through it all and make sense of it in order to confidently draw the right conclusions and share the right results. Discover how to quickly and easily find, synthesize, and share information—accelerating and improving R&D.

 RELATED: Pharmacy takes FDA to task in citizen petition over tainted valsartan 

“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,” the FDA said. 

The agency is not recommending patients quit using their medicines. Patients who take a prescription version should check with their doctor before quitting, the FDA said. Those who buy them over the counter might consider switching to an antacid that doesn’t contain ranitidine, which is an H2 (histamine-2), of which there are many.  

RELATED: FDA temporarily retreats from impurity standards as losartan shortages loom

In a statement, Sanofi pointed out that Zantac has been sold over the country for more than a decade and meets all of the FDA's requirements. But it said it is working the the FDA on the matter.

By Monday, the situation had generated its first lawsuit

The FDA more than a year ago discovered the probable cancer-causing impurity NDMA was showing up in valsartan blood pressure meds made with an ingredient from China. It has been trying to get its arms around the problem since. 

The discovery set off a global recall which has expanded exponentially as regulators found two other impurities. N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) and NDEA, along with NDMA, can be created during sartan drug manufacturing under certain conditions. All are considered unsafe at certain levels. The recall was extended to some irbesartan and losartan drugs, causing shortages of losartan.

Suggested Articles

Sanofi spent months hyping its Tuesday investor event, and new CEO Paul Hudson certainly laid out a different vision for the drugmaker at the confab.

After more than 10 years as partners, Sanofi and Regeneron are splitting up their deal to comarket PCSK9 med Praluent and immunology drug Kevzara.

Fujifilm has completed the first manufacturing facility in Japan to make drug-delivering liposomes to use for cancer fighting drugs it is developing.