(April 2, 2020) – The U.S. FDA ordered drug makers yesterday to stop selling their versions of heartburn medication ranitidine – Zantac – because of potentially carcinogenic contaminants.
The FDA warned in September 2019 that it found a potentially toxic compound called N-nitrosodimethylamine (NDMA) at “low levels” in Zantac and other ranitidine medications. The agency said yesterday that recent testing raises questions about whether such impurities increase when stored above room temperature.
Director of the FDA’s Center for Drug Evaluation and Research, Janet Woodcock, said:
“We didn’t observe unacceptable levels of NDMA in many of the samples that we tested. However, since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients unless its quality can be assured.”
Related: Zantac Cancer Lawsuit
The agency said people who still have the drugs should not return them now, but follow agency guidelines for home disposal.
The FDA also said it had not found contamination in similar ranitidine drugs like Pepcid and Nexium.
The agency has investigated Zantac for more than a year. The warning it issued in September 2019 triggered a Swiss drug maker unit of Novartis AG to stop all distribution.
NDMA a Probable Human Carcinogen
The FDA classifies NDMA as a probable human carcinogen. FDA has been investigating NDMA and other impurities in blood pressure and heart meds since last year.
The September 2019 FDA warning also triggered a wave of Zantac cancer lawsuits against drug companies. Suits charge that they failed to warn about their drugs’ links to cancer.
In October 2019, a Colorado man diagnosed with bladder cancer sued Pfizer Inc., Sanofi US Services Inc., and other drug companies. He alleged that they failed to warn him Zantac can produce a carcinogen when digested by human beings.
In January 2020, a New Jersey woman hit Pfizer with a proposed class action lawsuit that accuses the company of promoting a worthless product.
Sanofi Aventis US LLC also faces Florida state court litigation that alleges the company should have known about the dangerous substance after illness reports and a lawsuit in the Philippines. The lawsuit charges that the company ignored the evidence and has continued to market and sell the drug as safe for use.
FDA orders Zantac Heartburn Drug Recall
The FDA recall announcement again failed to address what appears to be the most dangerous manifestation of Zantac. The drug is thought to release great amounts of NDMA in the human gut as it is heated during digestion. Despite the recall announcement, the FDA again strangely fails to consider how human ingestion raises the levels of cancer-causing NDMA.