The National Agency for Food and Drug Administration and Control (NAFDAC) has alerted Nigerians of a genotoxic impurity in Zantac injection 50mg/5ml batch number 669.
The agency was informed that Swissmedic, the National Medicines Regulatory Authority of Switzerland has detected low levels of N-Nitrosodimethylamine (N-NDMA), a genotoxic impurity which are known to be potentially carcinogenic when ingested, inhaled or penetrate the skin.
As detected by the Medicines Control Laboratory of Swissmedic, the value of N-NDMA found was 0.3ppm relative to the active substance and consequently above the agreed threshold of 0.16ppm in Europe for NDMA in Ranitidine Hydrochloride.
Ranitidine is a medicine used to treat and prevent ulcers of the stomach and intestine. It belongs to a group of medicines known as H2-Blocker. It works by reducing the amount of acid that the stomach produces.
N-NDMA has been classified by International Agency for Research on Cancer (IARC) as probably carcinogenic to humans. It was reported that the impurity was also detected in the active `pharmaceutical ingredient (API) manufactured by Saraca Laboratory.
Following the detection of the impurity, some countries and their National Medicines Regulatory Authorities have taken various actions:
|1.||Switzerland||Swissmedic||Glaxo SmithKline (GSK) instructed to carry out pharmacy/retail level recall of all Zantac batchesin Swiss market. Swissmedic asked for recall of all ranitidine containingproducts from Swiss market.|
|2.||Singapore||HSA||HSA tested all locally available ranitidine products forthe presence of nitrosamine compounds and foundthat the products contained NDMA. The APIs wassupplied by Dr. Reddy’s Laboratory India andSaraca Laboratory. GSK was instructed to suspend the wholesale supplyand conduct class 2 (retail level) recall of Zantac.|
|3||USA||USFDA||Issued a statement alerting patients and healthcare professionals on NDMA found in samples ofranitidine.|
|4||Finland||FIMEA||GSK instructed to implement Pharmacy/retail level recallof all Zantac products (Tablets, effervescent tabletsand syrups) from the Finish market.|
|5||Ireland||HPRA||Prepare to recall Zantac products manufactured usingAPI from Saraca Laboratory from Pharmacies andretail levels in Irish market.|
|6||Denmark||DMA||GSK requested to implement a pharmacy/retail levelrecall of all Zantac products (Syrups and injections)from Danish market.|
|7||Saudi Arabia||SFDA||GSK instructed to carry out a pharmacy/retail level recallof all Zantac products (Tablets, effervescent tablets,injections and syrups) from the Saudi market.|
|8||Kenya||PBB||PBB decided that all ranitidine containing productsshall be recalled up to retail pharmacy level bytheir respective Marketing Authorization Holders(MAHs) until proved to be safe.|
Following the alert, the Glaxo SmithKline (GSK), the Marketing Authorization Holder (MAH) of Zantac in Nigeria has confirmed to NAFDAC that Zantac is no longer imported into Nigeria since the last batch of Zantac imported to Nigeria expired in November, 2018.
NAFDAC implores all Pharmaceutical importers to stop importation of all ranitidine containing products till further notice while imploring all distributors, wholesalers and retail pharmacies in possession of stock of ranitidine containing products should immediately stop distribution and sale of the products.