Carcinogen Found in Ranitidine

On September 13, 2019 the US Food and Drug Administration (FDA) issued a statement notifying clinicians and consumers of the discovery of a carcinogen in ranitidine.

Ranitidine (brand name Zantac) is an over the counter antacid medication.  We most commonly prescribe it to infants for treatment of gastroesophageal reflux disease (GERD).  Whereas colic used to be a common affliction in babies, we rarely diagnose it anymore because most of these babies have GERD.  Ranitidine has been very effective in taking away many of these babies’ pain. It has also decreased the risk of aspiration of stomach contents into the lungs in certain high risk babies, and it has eased the stress that parents of a fussy baby may feel.

Recently an online pharmacy that does their own drug safety testing discovered low levels of N-Nitrosodimethylamine (NDMA) in ranitidine.  It is unclear which brands of ranitidine contain it, but it was found in Zantac and many of the generic versions.  It seems that the source of the NDMA contamination may be from one manufacturer in India.

NDMA is an environmental contaminant commonly found in water, meats, dairy products, and vegetables. At high levels it is carcinogenic. Here is what the FDA said about it:

“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.”

At this point the FDA is not advising people to stop taking ranitidine.  On the other hand, Canada is halting distribution of all brands of ranitidine.  The FDA is engaged in further testing to determine the risk of the NDMA in ranitidine.

If your child is taking ranitidine, please call us to discuss options.  We may advise continuing it, discontinuing it, and/or switching to another antacid medication based upon your child’s situation.  Thank you for your understanding.