Why Did the FDA Approve Zantac if it Posed a Danger to Consumers?

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When the FDA requested the withdrawal of all ranitidine based products including Zantac on April 1, 2020, it wasn’t because the initial FDA testing of Zantac that led to its approval was somehow faulty.

It wasn’t until a third party laboratory found high levels of N-Nitrosodimethylamine (NDMA), that the FDA continued its investigation.  They found that impurity (NDMA) in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. 

Further testing of ranitidine found that storage of the drug for prolonged periods of time or at higher than room temperatures significantly increased the levels of NDMA.  Also, according to the FDA, “The testing also showed that the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA. These conditions may raise the level of NDMA in the ranitidine product above the acceptable daily intake limit.”

A voluntary recall of these medications had been implemented by two companies in January after the FDA detected the cancer-causing chemical N-nitrosodimethylamine (NDMA) in several brand name and generic heartburn medications.

Initially approved in 1983, Zantac has been one of the most popular drugs on the market worldwide. Glaxo aggressively marketed the safety of the drug, which resulted in $1 billion total Zantac sales in December of 1986.  Since that time various pharmaceutical companies have acquired the marketing rights to Zantac including:  Glaxo, Warner-Lambert, Pfizer, Boehringer, and finally Sanofi in 2017. 

In spite of Zantac’s popularity and the emergence of generic equivalents, the pharmaceutical companies marketing the antacid drug knew about the drug’s dangers, especially its link to cancer. 

A 2011 scientific study found that, out of eight pharmaceuticals that were observed, “ranitidine showed the strongest potential to form N-nitrosodimethylamine (NDMA)” when present in drinking water during chloramine disinfection, and that “ranitidine gave a much higher yield of NDMA in the present study than reported in [previous] literature.

In 2016, a peer reviewed study in the scientific journal Carcinogenesis found an alarming 400 fold increase in the quantity of NDMA in urine excreted by the patient during a 24 hour period after ingestion of the drug. 

Yet, Zantac and its generic equivalents continued to be marketed to unsuspecting healthcare professionals and ingested by consumers. 

The dangers that NDMA poses to human health have long been recognized. A news article published in 1979 noted that “NDMA has caused cancer in nearly every laboratory animal tested so far.” NDMA is no longer produced or commercially used in the United States, except for research.”

If you or a loved one have been prescribed Zantac, taken an over-the-counter form of ranitidine and been diagnosed with cancer, please contact Attorney David Rheingold for a free initial consultation. 

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