The FDA and Zantac
Despite voluntary recalls from manufacturers (including Sanofi and Glenmark Pharmaceuticals) and scathing comments from health experts and at least one congresswoman, the FDA hasn’t pulled ranitidine (Zantac is a brand name version of ranitidine) from its shelves, nor has it even advised the public to stop taking ranitidine products. Instead, the agency is “investigating whether the low levels found in the ranitidine medicines create a health risk.” Its latest update (Jan 8, 2020) “alerts patients” to two voluntary recalls of ranitidine. Fierce Pharma wrote that:
Due to a historically very high perception of safety, ranitidine is heavily prescribed to adults and infants and sold over-the-counter…. FDA's failure to stop companies from selling ranitidine makes the United States government complicit in exposing infants and adults to the risk of cancer,” reads the letter to FDA Director Stephen Hahn and his boss Alex Azar, secretary of Health and Human Services.
Cancer Zantac Lawsuits
Last August, 44-year-old Jill Goldstein filed a lawsuit against Zantac manufacturers Sanfoi U.S., Pfizer, GlaxoSmithKline and Boehringer Ingelheim Pharmaceuticals, claiming the antacid gave her breast cancer. One month later she underwent a lumpectomy, following a diagnosis of a hormone receptor-positive ductal carcinoma. The chances of her developing cancer increased by 240 percent due to Zantac, according to the lawsuit.
Her lawsuit is further bolstered by a 2008 study by the Fred Hutchinson Cancer Research Center that found people who take Zantac were at an increased risk of developing the same type of cancer Goldstein has. “If only the makers of Zantac had put aside their greed and heeded the 2008 peer-reviewed study by the Fred Hutchinson Cancer Research Center, Jill Goldstein would not be going through the hell she is subjected to now,” attorney Yechezkel Rodal said in the 41-page lawsuit filed in U.S. District Court in West Palm Beach, as reported by the Palm Beach Post. The lawsuit was filed in U.S. District Court in West Palm Beach.
"Yet, the makers of Zantac did nothing. They said nothing. Jill Goldstein is now paying the price," the lawsuit states. The lawsuit accuses the defendant of design defect, failure to warn, negligence, breach of express warranty, breach of implied warranty and negligent misrepresentation.
Another Zantac lawsuit was recently filed in the U.S. District Court for the Northern District of Ohio. After taking two Zantac pills per day for 12 years, an Ohio woman says was diagnosed with Stage Stage IV kidney cancer. This type of cancer starts in the kidneys and occurs when healthy cells in one or both kidneys grow out of control and form tumors.
READ MORE ZANTAC HEARTBURN MEDICATION LEGAL NEWS
These two cases, along with many others pending in court, claim that the NDMA in Zantac and generic ranitidine is not an impurity, as the FDA calls it, but a natural by-product of the breakdown of ranitidine in the digestive system. Valisure, the online pharmacy that first detected NDMA in ranitidine during routine testing, agrees that ranitidine is unstable and can form NDMA during the digestive process.