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All ranitidine antacid medicines – not just Neotack – withdrawn from Kenyan market after cancer findings

The Kenyan government has “withdrawn from the market, all anti-acid Ranitidine sold in Kenya as Neotack after it was linked to cancer in the US”, claims a post shared on Facebook on 2 October 2019.

It shows a photo of a pack of Neotack 150, a brand of medicine that contains the drug ranitidine in 150 milligram doses. Ranitidine is an antacid, a drug that helps stop the stomach from producing too much acid.

Has Neotack been withdrawn in Kenya?



‘Recall and quarantine’ by Kenyan authority


Kenya’s drug regulatory authority, the Pharmacy and Poisons Board, did issue a public safety alert on 2 October 2019 warning of a “genotoxic contaminant… in ranitidine products”.

The alert came after pharmaceutical regulators in seven countries, including Switzerland, Singapore and the US, recalled ranitidine drugs in September 2019. 

Some ranitidine products had been found to contain a cancer-causing substance called N-nitrosodimethylamine (N-NDMA). This prompted the recalls.

The Kenyan board took three steps, outlined in the alert. First, it recalled “all products” containing ranitidine from the Kenyan market. 

It then stopped the import or sale of products containing ranitidine “pending conclusion of regulatory investigations”. 

Finally, it asked doctors to “prescribe available alternatives” and advised that “patients should also use alternative medicine”.

The board did not say that Neotack 150 alone was being recalled.

Lab tests in Switzerland


The US Food and Drug Authority issued a statement on 13 September 2019 warning that the cancer-causing impurity had been found in ranitidine in the US.

The Kenyan regulator said it had to take action because laboratory tests in Switzerland had found N-NDMA in ranitidine, leading to the recall of the drug in Switzerland and six other countries, including the US.

The pharmacy board described NDMA as a “potent carcinogen in experimental animals by several routes of exposure, including through ingestion of drinking-water”.

 ‘Probably carcinogenic’


The International Agency for Research on Cancer classifies NDMA as “probably carcinogenic to humans”.

“The mechanism by which NDMA produces cancer is well understood,” said Kenya’s drug regulator.

So yes, all medicines containing ranitidine, including but not limited to Neotack 150, have been withdrawn from the Kenyan market. – Grace Gichuhi




 

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