Updated on : 03-10-2019
Health and Wellness Ministry Halts Imports of Ranitidine
The Ministry of Health and Wellness 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.
Ranitidine is a Histamine-2 (H2) blocker, which decreases the amount of acid formed in the stomach. It is commonly sold in Jamaica as the branded product Zantac or as generic formulations, such as Apo-ranitidine, Las-ranitidine, H2K-ranitidine, Aciloc and Ranitin, among others.
The product is available in different strengths and dosage forms (tablets, syrup, injectable), and is used in the treatment and prevention of various conditions, such as heartburn, ulcers of the stomach and gastroesophageal reflux disease (GERD).
Current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer. 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. Following suit, current stocks being held within Jamaica will be allowed to be depleted. However, individual Marketing Authorisation Holders may choose to completely withdraw their products.
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.
Persons with concerns may contact the Ministry’s National Pharmacovigilance Programme by completion and submission of the PHARMWATCH Drug Monitoring Form available at www.moh.gov.jm/forms.
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.
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