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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.

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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.

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  • We need to stop using these countries. Their supply chain cannot be trusted. The small amount in increased costs from having drugs fully manufactured in America would pale in comparison to the price hikes pharmaceutical companies make for no legitimate reason.

  • We will definitely continue to have issues such as these as long as we outsource generics & others to countries like India where no surprise FDA inspections are allowed. Ingredients from China are suspect at best. Meanwhile, US politicians continue to scream for MORE GENERICS while having no clue of of the filthy, disgusting “labs” where these drugs are made. If you read Katherine Eban’s book “Dangerous Doses”, you will be horrified. Yet this is not surprising at all. Very scary but not surprising.

  • Ed, of course you’ve been following the NDMA issue re: generic valsartin. Since this issue has been around since 2018, are their enough safeguards in place to have confidence in valsartan, as long as it’s not on the recall list? Or is it still a chancy proposition?

    • Hi Peter,

      Apologies for the belated reply.

      You ask a key question, of course, but I don’t wish to speculate.

      The answer is complicated because NDMA appeared in products made by different companies so while, arguably, the processes used by those companies were the same or similar, perhaps the outcomes varied.

      I would like to think the regulators – not just FDA, but EMA – are getting their arms and heads around the issue, and the FDA has attempted to assure consumers about the levels found in blood pressure pills.

      If anyone remains concerned, however, the response is simple – vote with your feet and work with your doctor to find an effective alternative. But I’m not in the business of giving medical advice.

      Hope that helps,
      ed at pharmalot

    • 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.

    • Isn’t it ironic that American Pharmaceutical mfgs. are opposed to U.S citizens getting their pharmaceuticals from Canada because the U.S mfgs. couldn’t guarantee the purity of the Canadian product, when both more than likely have the same origin.

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