Gov’t bans ranitidine; distributors to withdraw drug from pharmacies
DISTRIBUTORS of the drug ranitidine, which decreases the amount of acid formed in the stomach, will be withdrawing them from pharmacies islandwide, following yesterday’s announcement of an import ban on the product by the Ministry of Health and Wellness.
Pharmacists, who requested anonymity, told the Jamaica Observer yesterday that distributors made contact and advised them of plans to withdraw the drug following the late morning ban announced by the health ministry.
The drug is sold in Jamaica as the branded product Zantac as well as in generic formulations such as Apo-ranitidine, Las-ranitidine, H2K-ranitidine, Aciloc and Ranitin, among others.
Last month, the Food and Drug Administration in the United States said that some ranitidine medications, including the brand name Zantac, were found to contain low levels of an impurity that could possibly cause cancer.
The Ministry of Health and Wellness said yesterday that the decision to ban the drug was made after it became aware of the presence of low levels of a genotoxic nitrosamine impurity, N-nitrosodimethylamine, in ranitidine preparations, following reports by the United States Food & Drug Administration, Health Canada and the European Directorate for Quality of Medicines.
The contaminant is was reportedly detected during a routine post-market testing.
According to the CNN, Walmart, the United States’ largest retailer, is the latest to announce it was suspending the sale of Zantac and other over-the-counter ranitidine medications due to concerns that they might contain a substance that can cause cancer. CVS Pharmacy and Walgreens in the United States recently announced they would no longer be selling the medication.
Ranitidine is a Histamine-2 (H2) blocker which decreases the amount of acid formed in the stomach.
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.
Jamaica’s health ministry yesterday advised patients presently taking over-the-counter ranitidine for simple heartburn to ask their pharmacists or other healthcare providers to recommend suitable substitutes, such as antacids. At the same time, patients for whom ranitidine has been prescribed were asked to talk to their physicians regarding other treatment options available.
Pharmacists who spoke with Observer yesterday all agreed that there are several alternatives to the drug and so the ban should not be that “much of an issue”.
One pharmacist, who spoke on the condition of anonymity, said, “Persons might miss it but there are other options. The other options might not be in the same class, but yes, there are alternatives.”