The Food And Drug Administration Stands By The Safety Of Ranitidine Despite Issuing A Recall

Recall Lawyer News

Plaintiffs suing Sanofi will need to present concrete scientific evidence that ranitidine becomes NDMA under normal circumstances

Friday, July 9, 2021 - Lawyers for plaintiffs suing Sanofi over ranitidine causing cancer are in for a fight because the science supporting their claims may not hold water. Plaintiffs blame taking Zantac regularly for many years, created elevated levels of N-nitrosodimethylamine (NDMA), a deadly carcinogen that leads to cancer. Other scientists believe that the methods used to test ranitidine may have been the cause of the NDMA spike. Online prescription drug testing pharmacy Valisure may have overheated the samples of Zantac, and doing so caused ranitidine to break down and become carcinogenic. This could reasonably be assumed since only Valisure has, to date, found enormously levels of NDMA in the millions of nanograms per tablet, when FDA tests found only slightly more than the 96 nanograms per pill, a level the agency assumed was safe. The FDA thinks that the 96 NGS of NDMA may be overly cautious when compared to the levels of everyday foods we eat contain. The FDA summarized their analysis of ranitidine and NDMA and wrote, "The FDA has determined that the levels of NDMA in ranitidine and nizatidine are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats." According to the American Journal of Managed Care, "The FDA learned an independent laboratory found NDMA in ranitidine in the summer of 2019. When the FDA conducted testing, it found NDMA in low levels, which would not be expected to lead to an increase in risk in cancer." Visit Zantac antacid cancer lawsuit to learn more.

Another way plaintiff lawyers may be overly optimistic about their chances is because, assuming ranitidine‘s natural defect causes cancer under normal conditions, there has not been a concrete connection made between elevated levels of NDMA and getting cancer. Plaintiffs claim that they developed cancer of the stomach, bladder, esophagus, colon, prostate, and others from taking the heartburn and acid reflux medicine. There are many ways cancer can occur and it may be impossible to isolate taking Zantac as being the definitive source. Drinking excessively hot beverages can damage cells and lead to throat cancer. Women that drink heavily have a 33% greater likelihood of developing breast cancer. Living or working around a microwave transmitter or cell phone tower can expose a person to carcinogenic radiation. Eating charred, well-done temperatures of hamburgers, steak, pork, or chicken is also a cancer risk. Of course, exposing the skin to tanning or sunburn is also a good way to get cancer, and many, many more. Ruling out these behaviors may be difficult or impossible when trying to isolate ranitidine as the cause of the disease.

Despite the evidence pointing to ranitidine being safe for human consumption, the FDA recalled all types of ranitidine both brand and generic on April 1, 2020. The recall was initiated by Valisure filing a petition with the agency requesting the removal.