FDA warning on ranitidine under check, says MoH

Muscat: The Ministry of Health is following up the warning by US Food and Drug Administration’s (FDA) warning that some ranitidine medicines, including common Zantac brand, contain some 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,” an announcement from the
Ministry of Health said on Sunday.

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 ministry also confirmed that it will follow closely any developments in this regard and issue updates accordingly.

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.

In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.

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.

The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their healthcare professional about other treatment options.