The state-run Tanzania Medicines and Medical Devices Authority (TMDA) has suspended the use of medicines containing the active pharmaceutical ingredient Ranitidine until further notice.
The products are Ranitidine Hydrochloride 150 milligramme tablets going by the brand name Raniplex, manufactured by Cyprus-based Remedica Ltd; Ranitidine Hydrochloride 500mg or 2-mililitre injection solution (brand name Rantac) prepared by India's Unique Pharmaceutical Laboratories (a division of JB Chemicals & Pharmaceuticals); and Ranitidine Hydrochloride 150mg tablets (brand name Aciloc) produced by another Indian firm, Cadila Pharmaceuticals.
The TMDA said in a media statement Tuesday that the suspension covers all medicines containing Ranitidine. Healthcare providers in Tanzania have been directed to stop prescribing such medicines and instead recommend alternative medications registered by TMDA which can be used to treat the same conditions and diseases.
Patients currently using such medicines have also been ordered to stop forthwith and embrace the alternative options.
Ranitidine is used in controlling gastric acid production in heartburn, in the treatment and prevention of ulcers of the stomach and intestines, as well as treatment of gastroesophageal reflux disease.
TMDA acting director general Akida Khea said in the press release on Tuesday that the suspension follows an investigation conducted by the agency into the safety of at least three medicinal products containing Ranitidine currently on the local market.
Mr Khea said the TMDA investigation, conducted in collaboration with the manufacturers, was based on safety alerts issued by international drugs agencies including the European Medicines Agency, the United States’s Food and Drugs Administration, Therapeutic Goods Administration (Australia), and Swissmedic.
"The safety alerts regarded the presence of a potentially carcinogenic impurity known as N-nitrosodimethylamine (NDMA) in medicinal products containing Ranitidine as their active ingredient either alone or in combination with other active ingredients," TMDA said in its release.