According to the Food and Drug Administration (FDA), a nitrosamine impurity, N-nitrosodimethylamine (NDMA), has been identified in some samples of ranitidine. NDMA was one of several nitrosamine impurities implicated in the massive recall of angiotensin II receptor blockers (ARBs) since last year.
NDMA is classified as a probable human carcinogen; the impurity was identified following laboratory testing conducted by the FDA. The Agency is working to determine the source of the impurity, as well as the risk it may pose to patients.
Ranitidine, an H2-blocker, is available by prescription for the treatment of active duodenal or benign gastric ulcer; maintenance of healing of duodenal or gastric ulcer; pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome and systemic mastocytosis); GERD; erosive esophagitis; and for maintenance of healing of erosive esophagitis. It is also available over-the-counter for the relief and prevention of heartburn, acid indigestion, and sour stomach.
At this time, the FDA is not advising patients to stop taking ranitidine, however, as similar therapies are available, alternative medications could be considered.
“Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods,” said Janet Woodcock, MD, Director-Center for Drug Evaluation and Research. “The Agency will provide more information as it becomes available.”
For more information visit fda.gov.