Dar es Salaam. All patients taking heartburn drugs with the active ingredient ranitidine must stop their course of treatment and report to a nearby health facility after authorities raised concern about the safety of the drugs.
Tanzania Medicines and Medical Devices Authority (TMDA) said yesterday that the drugs, with the trade names Raniplex 150 mg, Rantac 500 mg/mL and Aciloc 150 mg, which were registered for use in Tanzania, contain an impurity that can cause cancer.
The drugs, in the form of tablets and solutions for injection, are used to control heartburn and treat and prevent stomach and intestinal ulcers and other stomach conditions.
TMDA’s decision comes after international medicines agencies warned that drugs containing ranitidine or sold in combination with other ingredients were not safe for use anymore and were subject to further investigation.
An earlier warning came from the European Medicines Agency (EMA), United States Food and Drugs Administration (USFDA), Therapeutic Goods Administration (TGA – Australia) and Swissmedic (Switzerland).
Tanzania becomes the latest country to ban the drugs from sales and prescription
Canada and France have already announced Zantac recalls. The US and the European Union are investigating.
In a statement, TMDA acting director general Akida Khea said: “The authority has investigated the safety of these products in collaboration with the manufacturers and based on the findings of the investigation, the authority has decided to suspend the registration and henceforth the use of all medicines containing the active ingredient ranitidine until further notice.
“Healthcare providers are directed to stop prescribing the concerned medicines and they are required to prescribe alternative medications which have been registered by TMDA,” the statement reads.
They are traded by Remedica Limited, Cyprus, Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd), India and Cadila Pharmaceuticals Limited, India.