New Class-Action Lawsuit Filed Against Zantac Manufacturers Because of Potential Cancer Risk

On September 26, 2019, five plaintiffs jointly filed a class-action lawsuit against Sanofi-Aventis LLC, makers of the stomach-acid medication, Zantac (ranitidine).  They’ve also named as defendants Boehringer Ingelheim Pharmaceuticals, Inc., which owned the U.S. rights to Zantac and manufactured and distributed the drug from October 2006 to January 2017, after which Sanofi acquired the rights.

The plaintiffs claim the defendants deceived the public about Zantac’s safety and failed to warn doctors or consumers that Zantac could produce the chemical N-Nitrosodimethylamine (NDMA) during the digestive process.  The Environmental Protection Agency (EPA) has classified NDMA as a probable human carcinogen.

FDA Warns of Potential Contamination with Zantac and Generic Ranitidine

In September 2019, manufacturer Sandoz initiated a recall of ranitidine capsules (generic Zantac) after testing discovering NDMA in batches of the drug.

The FDA notified healthcare providers and the public of the recall on September 24, 2019, stating a nitrosamine impurity had been discovered in the recalled medicine.  The FDA has also conducted its own tests on ranitidine products and is continuing to investigate whether the products have NDMA levels that exceed acceptable limits.

Ranitidine and Zantac are available as over-the-counter and prescription drugs.  They are histamine-2 blockers, which work by decreasing the amount of acid in the stomach.  They are used to treat conditions like heartburn, acid indigestion, sour stomach, ulcers, and gastroesophageal reflux disease (GERD).

Patients were advised to follow the recall instructions provided by Sandoz, as well as those provided by Apotex Corp., which initiated its own ranitidine recall on September 25, 2019.  The FDA provides information on these recalls on its website.

Independent Testing Shows High Levels of NDMA in Zantac

Valisure, an online pharmacy that stakes its reputation on testing the drugs it sells, submitted a citizen petition to the FDA in June 2019 requesting that the agency take action after Valisure detected levels of dimethylformamide (DMF) in blood pressure drugs.  DMF is a solvent that can form nitrosamine impurities like NDMA.  Valisure noted that since pharmaceutical manufacturing switched to the use of DMF as a solvent, nitrosamine impurities started showing up in heart disease drugs like valsartan.

Valisure reported that it found high levels of NDMA in all lots of ranitidine tested, across multiple manufacturers of ranitidine products.  Valisure submitted another citizen petition to the FDA, noting that the ranitidine molecule itself contains both a nitrite and a dimethylamine (DMA), which are known to combine to form NDMA.

The FDA recently set an acceptable intake level of 96 ng a day of NDMA, though some data indicates even that may be too high.  Valisure’s testing of Zantac detected 2,511,459 ng of NDMA per 150 mg tablet of Zantac.  In a follow-up test of Zantac in conditions simulating the human stomach, the quantity of NDMA was as high as 304,500 ng per tablet.

The plaintiffs in the class-action lawsuit allege that the defendant Zantac manufacturers knew or had reason to know that Zantac exposed users to unsafe levels of NDMA, since numerous scientific studies indicated it did, yet they failed to disclose the risk and continued to sell the product to the public.