A brand of the ulcer and GERD treatment nizatidine is being recalled after it was discovered the oral solution contained NDMA, a probable human carcinogen, at levels exceeding what is considered safe for daily human consumption. Nizatidine is the active ingredient in the brand-name over-the-counter drug Axid, and generics.
Nizatidine is in a class of drugs called histamine (h2) receptor antagonists, which includes Zantac, the brand-name version of the heartburn drug ranitidine, which was removed from the market April 1 after it was found that levels of NDMA increase to unacceptable levels during certain conditions, such as at higher temperatures and longer shelf life.
The recall affects three lots of Amneal Pharmaceuticals LLC’s Nizatidine Oral Solution, 15 mg/mL (75mg/5mL) packaged in 480 mL bottles. The medication is used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). Affected lot numbers can be found on the company’s news release.
In January, Mylan Pharmaceuticals announced the recall of three lots of Nizatidine Capsules due to the presence of NDMA. Despite at least two recalls of nizatidine due to the presence of the impurity, the FDA has not called for the withdrawal of nizatidine products as it did with Zantac/ranitidine products.
NDMA has been found to induce tumors in laboratory rats. There have been no published studies to identify how great the risk of cancer is for users of these heartburn drugs or the specific cancers it may cause. But, research suggests that cancers associated with NDMA exposure include stomach, small intestine, bladder, kidney, colorectal, esophageal, prostate, pancreatic, leukemia, non-Hodgkin’s lymphoma, and multiple myeloma.
Beasley Allen attorneys Frank Woodson and Lisa Courson are actively investigating potential claims involving regular Zantac/ranitidine use that may have led to cancer of the stomach, colon, intestines, kidneys, bladder or pancreas. If you or a loved one may have been affected, please contact us.