What a difference one month can make. The FDA on October 22 released a statement after finding the levels of NDMA in Zantac “unacceptable”, which is a far cry from its previous September 13 announcement, which said that “ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods”. The FDA has advised drug companies to recall their Zantac (also known as ranitidine) if testing shows levels of NDMA above the acceptable daily intake, which begs the question: If so little is known about Zantac cancer risk, how can “acceptable” be measured?
In a Colorado federal court, plaintiff Mark Allan Blake claims that Pfizer Inc., Sanofi US Services Inc. and other drug companies failed to warn him that the antacid medication) can produce a carcinogen called NDMA when digested.
Blake told a Colorado federal court that Zantac’s only use is to “induce tumors in animals as part of laboratory experiments…Its only function is to cause cancer. It has no business being in a human body,” according to court documents. Blake’s lawsuit argues that research going back to 1981 shows that that Zantac can produce high levels of NDMA, that drug companies knew or should have known about the risks, but hid this from the FDA.
In his lawsuit, Blake said the same level of NDMA found in one 150 mg dose of Zantac is the equivalent of smoking 6,200 cigarettes. He has taken Zantac four times a week since 1996 and was diagnosed with bladder cancer last year. The case is Blake v. Boehringer Ingelheim Pharmaceuticals Inc. et al., case number 1:19-cv-02991, in the U.S. District Court for the District of Colorado.
(A 2004 study found that people with peptic ulcers who were taking the antacid Zantac or Tagamet had a heightened risk of bladder cancer.)
Blake’s attorney is calling for Zantac to be immediately removed from the market and consumers need to be aware of safer alternatives. (According to the FDA, tests of samples of alternatives such as Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole) show no NDMA in the medicines to date.)
NDMA and Zantac Recalls
One week after the first lawsuit in Florida was filed, Novartis announced it was halting the sale of its version of Zantac in the U.S. At the end of October, the French pharmaceutical giant Sanofi announced a voluntary recall of its Zantac in the US and Canada.
Several blood pressure medications, including the angiotensin receptor II blockers valsartan, losartan and irbesartan, were recalled last year over NDMA contamination, reported Scientific American (Oct 28, 2019). The FDA was first alerted in June by the online pharmacy company Valisure about high levels of NDMA in ranitidine medications. In a citizen petition to the FDA in September, Valisure said it found “extremely high levels of [NDMA] ... in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine.” The petition states that Valisure detected levels greater than three million nanograms per tablet—far exceeding the FDA’s daily limit of 96 nanograms.