Skip to Main Content

Regulators in the U.S. and Europe are investigating why traces of a possible carcinogen were found in certain heartburn drugs, including Zantac, more than a year after the same impurity was found in some blood pressure pills, a revelation that has raised questions about the safety of the pharmaceutical supply chain.

At issue is NDMA, an organic chemical that was once used to make rocket fuel and is an unintended by-product of certain chemical reactions. Last year, the substance was detected in a class of medicines known as angiotensin II receptor blockers, notably, valsartan, prompting an increasing spate of product recalls even as regulators have attempted to reassure consumers that cancer risks are low.


On Friday, both the Food and Drug Administration and the European Medicines Agency released statements disclosing that NDMA was found in certain ranitidine medicines, which are histamine-2 blockers that decrease the amount of acid created by the stomach. The medication is sold both over-the-counter and by prescription.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

  • All that i will say on this and other health issues with regards to The .F.D.A . and other Federal Health Care Regulatory Institutions . I have no confidence ,nor trust with them . Too much have taken place over time to trust them all .Once again ,Merck years ago is only one of where The F.D.A failed completely resulting in The Deaths of more than five hundred thousands deaths from Vioxx depending on which News Organization you read . i thank you . Trevor . A. Merchant . today . Tuesday . September, 17. 2019 at 4.51 p.m daylight savings time . New York City ,

  • This is an important issue that has to be considered for all drugs.
    Since this impurity was also reported for some antihypertensive drugs, it may come from the inactive ingredients (such as fillers, bonding chemicals etc) that are a part of the pharmaceutical forms such as tablets or capsules.In this case this carcinogen chemical can be avoided by changing the formulation of the pills. On the other hand, from this report it is not clear whether NDMA is formed during the synthesis of ranitidin (or the antihypertensive drug) and thus contamination comes as a byproduct of drug synthesis. In this case source of the active ingradient should be questioned.

  • I’ve taken Zantac for many, many years to protect my stomach from another medicine I have to take that is very hard on the stomach. Can I stop it cold turkey? Is their an equivalent to Zantac that is known not to have this carcinogenic chemical in it?

  • Ed, thanks for reply. Yes patients should get MDs advice on whether to switch meds, but the worry is that the new med may have quality issues as well, but not yet discovered. The other option is to take the brand name vs. generic product, but at the moment, Diovan is 11 times the cost of generic valsartan and if you are within deductible, that comes out of pocket.

Comments are closed.