Pharmaceutical drug ranitidine banned from entering Jamaica

Through its Ministry of Health and Wellness, the country said the ban, which is with immediate effect, became necessary after its counterparts in North America and Europe found “low levels” of the contaminant genotoxic nitrosamine impurity during a routine post-market testing.

According to several science journals genotoxic impurities can damage human genetic material at very low levels, leading to DNA mutations which can possible contribute to the development of cancerous tumors in the body.

In a statement the health ministry said it “is formally notifying healthcare providers, distributors and patients that effective immediately, no further supplies of ranitidine will be allowed into the island.

“This decision comes as the ministry has become aware of the presence of low levels of a genotoxic nitrosamine impurity, N-nitrosodimethylamine (NDMA), in ranitidine preparations, through reports by the United States Food & Drug Administration (USFDA), Health Canada and the European Directorate for Quality of Medicines (EDQM). The contaminant was detected by way of routine post-market testing.” 

What is ranitidine?
In simple language ranitidine is an anti-ulcer drug which decreases the amount of acid formed in the stomach. It is also part of a larger family of drug called histamine-2 (H2) blocker or receptor antagonist. It is commonly sold in Jamaica under the brand name Zantac or as generic formulations, such as Apo-ranitidine, Las-ranitidine, H2K-ranitidine, Aciloc and Ranitin, among others, the ministry stated.

The product is available in different strengths and dosage forms (tablets, syrup, injectable), and is used to treat and prevent, in addition to ulcers of the stomach, other conditions such as heartburn and gastroesophageal reflux disease (GERD). 

“Current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer,” the ministry said. “As such, the Ministry is advising all companies marketing ranitidine products on the island that no further imports will be allowed.”

USFDA, Health Canada and the European Medicines Agency are permitting the use of ranitidine until stocks are depleted.

Strangely though, the Jamaican government has opted to follow this very odd decision by its partners up north and will permit “current stocks being held within Jamaica will be allowed to be depleted”.

“However, individual marketing authorisation holders may choose to completely withdraw their products,” it added.

“The Ministry is further advising patients presently taking over-the-counter ranitidine for simple heart burn to ask their pharmacists or other healthcare providers to recommend suitable substitutes, such as antacids. Patients for whom ranitidine has been prescribed should talk to their physicians regarding other treatment options available.

“The ministry will continue to gather safety information and update the public. If necessary, the ministry will take more stringent action to protect the health and safety of the nation.”

Persons with concerns may contact the ministry’s national pharmacovigilance programme by completing and submitting the PHARMWATCH drug monitoring form available at www.moh.gov.jm/forms.