Recent Recall of Ranitidine (Zantac) Due to Contamination

The over-the-counter antacid medication, Ranitidine, has recently been recalled by the Food and Drug Administration (FDA) for possible contamination with low levels of N-nitrosodimethylamine (NDMA). Not all forms of ranitidine have been implicated. So far, only those manufactured by Novartis/Sandoz and Apotex have been recalled. Out of an abundance of caution, several major drugstore chains (including CVS and Walgreens) have pulled Zantac and other generic versions of the drug from their shelves.

It’s important to note that this recall is based on an impurity found in the medication and not on the medication itself or the process by which it affects the body. It’s a matter of quality control.

N-nitrosodimethylamine (NDMA) is classified as a probable carcinogen based on several animal studies (NDMA studies in humans are very limited), and is likely to cause cancer only after high-dose exposures over a prolonged period. The NDMA contaminant in ranitidine is not known to pose any immediate health risks. Neither the FDA nor any of the manufacturers have received any reports of adverse events related to NDMA found in ranitidine.

This NDMA contaminant is one of the same impurities found in late 2018 in certain blood pressure medications (angiotensin II receptor blocker (ARB) medications such as losartan, valsartan, and irbesartan) that resulted in their recall.

As the FDA continues to investigate ranitidine, more details will become available. Based on the available information at this time, there is no evidence that other H2 blockers or other heartburn medications are affected by NDMA impurities. Consider switching to another H2 blocker such as famotidine (Pepcid) or cimetidine (Tagamet).

Now would also be an ideal time to discuss with your SHIFT physician whether certain lifestyle improvements (that can often cure the underlying problem rather than just treat it) would be more appropriate than settling for long-term management with a daily medication.

Key behavioral interventions to reduce need for heartburn medications include avoiding late-night eating, not lying down shortly after mealtime, and achieving appropriate levels of visceral adipose tissue. Also, avoiding aspirin, NSAID’s (such as ibuprofen or Aleve), caffeine, peppermints, alcohol and tobacco can be highly beneficial.