Mazie Slater Katz & Freeman is currently investigating Zantac / Ranitidine and Axid / Nizatidine claims.  The FDA has detected a nitrosamine impurity called N-nitrosodimethylamine (NDMA) in Zantac / Ranitidine at low levels. Sandoz, a division of Novartis, recalled “all quantities and lots within expiry of [its] Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with [NDMA] above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules.”

The World Health Organization (WHO) and the International Agency for Research on Cancer (IARC) have found that NDMA probably causes cancer, having classified NDMA as a Group 2A compound thereby defining it as “probably carcinogenic to humans.”  The FDA currently recognizes the danger of such compounds and, as a result, has set strict daily acceptable intake limits on NDMA in pharmaceuticals of no more than 96 nanograms.  There have been a multitude of manufacturer recalls of angiotensin receptor blocker (ARB) medications, such as valsartan and losartan, due to the detection of NDMA in excess of these limits.  The FDA is investigating this contamination of Zantac / Ranitidine further and will release its results as they become available.

A third-party pharmacy, Valisure, has tested Zantac / Ranitidine and detected extremely high levels of NDMA “in every lot tested, across multiple manufacturers and dosage forms.”  The NDMA levels were in “excess of 3,000,000 ng per tablet when analyzing ranitidine products, likely due to an inherent instability of the ranitidine molecule.”  When tested under “biologically relevant conditions,” Valisure found 23,600 to 304,500 ng of NDMA per tablet of Zantac / Ranitidine.  After testing related drugs, Valisure found that Axid / Nizatidine also contains or forms NDMA.

We are thus investigating Zantac / Ranitidine and Axid / Nizatidine cancer claims, including:

We are also investigating claims for people who paid for Zantac / Ranitidine or Axid / Nizatidine, without knowing about this contamination and its attendant risks, as well as claims for people concerned about the risk of cancer in the future.

Zantac – sold generically as Ranitidine — is an over-the-counter (OTC) and prescription drug. Ranitidine is an H2 (histamine-2) blocker, which is intended to decrease the amount of acid created by the stomach. Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid ingestion and sour stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. Axid – sold under the generic name of Nizatidine — is an H2 (histamine-2) blocker with similar indications.

Many of the companies manufacturing, distributing, and selling Zantac / Ranitidine and Axid / Nizatidine are based in New Jersey, where Mazie Slater is based.  For example, Sandoz’s U.S. headquarters is in Princeton, New Jersey, and Novartis’ U.S. headquarters in in East Hanover, New Jersey.  If you or someone you know has a potential  Zantac / Ranitidine or Axid / Nizatidine claim, contact one of our qualified Zantac / Ranitidine and Axid / Nizatidine attorneys today so that we can evaluate your claim.