Tanzania Medicines and Medical Devices Authority (TMDA) has directed all patients taking medication with an active ingredient Ranitidine to stop their course of treatment after regulatory authorities found it contains an impurity that potentially causes cancer.
TMDA said the medicine with trade names: Raniplex 150 mg, Rantac 500 mg/mL and Aciloc 150 mg, contains N-nitrosodimethylamine (NDMA)—an impurity that was recently found to cause cancer in humans. The medicine was registered by TMDA and was being prescribed in health facilities.
“Healthcare providers are directed to stop prescribing the concerned medicines and they are required to prescribe alternative medications which have been registered by TMDA,” says a public notice issued by the authority’s Acting Director General on November 18.
“…patients are advised to consult their healthcare providers to obtain new prescriptions depending on their disease conditions,’’ added TMDA, saying the medication has been banned “until further notice.”
But, TMDA stressed: “It should be noted that the suspension is only for the three products listed above and that other products containing ranitidine and manufactured by other manufactures have not been suspended and they can be used.”
The medicine, in the form of tablets and solutions for injection, is used for controlling heartburn as well as prevention of stomach and intestine ulcers. It had already been recalled in some countries.
TMDA’s decision comes after international medicines agencies warned that drugs containing ranitidine or sold in combination with other ingredients were unsafe and were subject to further investigation.
In September, the U.S. Food and Drug Administration (FDA) reported that some ranitidine medicines, including some products sold under the brand name Zantac, contained NDMA—the substance that had been classified as a probable human carcinogen, at low levels.
Reference: Suspending the use of Medicines Containing Ranitidine as an Active Pharmaceutical Ingredient (TMDA, November 18).