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(CNN) - Drug maker Novartis said it is stopping the distribution of all ranitidine drugs manufactured by Sandoz, a measure he called "precautionary" after it was discovered that acid-reducing medications contained an impurity.
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The measure comes after the US Food and Drug Administration. (FDA) and the European Medicines Agency announced earlier this month that the tests showed that some ranitidine products contained NDMA, which is classified as a probable human carcinogen according to laboratory tests.
The FDA is evaluating whether low levels of NDMA in ranitidine pose a risk to patients and said it will share the information when available.
Ranitidine is an over-the-counter and prescription histamine-2 blocker that decreases the amount of stomach acid.
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“A preventive pause in the distribution of all medicines containing ranitidine Sandoz in all our markets will remain in place with greater clarification, this includes capsules in the USA. Our internal investigation is ongoing to determine more details. In case of concerns, appropriate additional measures will be implemented in alignment with the relevant health authorities as necessary, ”Novartis said in a statement sent via email.
The drug manufacturer Sanofi, which manufactures ranitidine drugs sold under the Zantac brand, said in a statement sent via email on Thursday that it "currently has no plans to stop distributing or manufacturing Zantac or other ranitidine products outside of Canada."
“The FDA reported that the levels of N-nitrosodimethylamine (NDMA) in ranitidine in preliminary tests barely exceed the amounts found in common foods. We are working closely with the FDA and are conducting our own robust investigations to ensure that we continue to reach the highest levels of quality assurance and quality standards, ”said the Sanofi statement.
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The FDA has been investigating NDMA and other impurities in blood pressure and heart medications known as BRA since last year. Numerous recalls have been launched as the FDA found "unacceptable levels" of nitrosamines in those medications.
The FDA says that people do not need to stop taking ranitidine medication, but patients who take prescription versions may want to talk to their doctors about other treatment options, and people who take the over-the-counter version may consider other approved medications. for your conditions
NDMA can cause damage in large quantities, but the levels that the FDA found in preliminary ranitidine tests "barely exceed the amounts that you would expect to find in common foods," according to a statement last week from Dr. Janet Woodcock, director FDA research Centers for Drug Evaluation and Research.
Woodcock said the agency is working with international regulators and industry partners to determine the source of ranitidine impurity.
People can report adverse health reactions with ranitidine to the FDA MedWatch.
Heartburn Ranitidine
