MOH suspends registration of Zantac medicine in Oman

MOH said the Ranitidine medications, sold under the trade name Zantac, are used to treat stomach acid and ulcers contained low levels of Nitrosamine.

On September 15, MOH in a statement said it is following up the warning by US Food and Drug Administration’s (FDA) that some ranitidine medicines, including common Zantac brand, contain a dangerous substance.

The ministry said the US agency had indicated that the substance was classified as a potential human carcinogen — a substance that could cause cancer. According to the warning, the drug contains a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.

“The ministry and other competent authorities are evaluating whether low levels of the substance in ranitidine pose a risk to patients,” MOH said.MoH said it has taken the necessary precautionary measures with all authorities concerned to make sure that this substance is not present in the said medicine and marketed in the Sultanate.

The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year.

Ranitidine is an over-the-counter (OTC) and prescription drug. It is an H2 (histamine-2) blocker, which decreases 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 ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.