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BPOM takes contaminated stomach drugs off market over cancer risk
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A recent finding from the United States Food and Drug Administration and the European Medicine Agency that ranitidine products contained a small amount of N-Nitrosodimethylamine (NDMA) led the Indonesian Food and Drug Monitoring Agency to conduct a risk assessment on all products containing ranitidine. (Shutterstock/ADragan)
T
he Indonesian Food and Drug Monitoring Agency (BPOM) has suspended sales of drugs containing ranitidine, commonly used to treat stomach problems, following reports from the United States and Europe that the medication may be contaminated with a carcinogenic substance.
The BPOM approved ranitidine medicines, used to decrease stomach acid production, for sale in the country in 1989.
However, recent findings by the US Food and Drug Administration and the European Medicine Agency (EMA) that ranitidine product samples contained a small amount of N-Nitrosodimethylamine (NDMA) had prompted the agency to conduct a risk assessment of all products containing ranitidine, the BPOM said in a statement on Oct. 4.
The agency cited a global study that determined the acceptable daily intake of NDMA at 96 ng. An intake higher than that would be carcinogenic under long-term consumption, meaning it would have the potential to cause cancer, the statement said.
"There are 70 pharmacy firms producing ranitidine products [sold in Indonesia]. The BPOM has run a [risk] assessment on some of the products and the results showed that some of them have been found to contain NDMA amounts exceeding the limit allowed for consumption [...]. We will recall these products. The assessment of all the products will be done in stages," the agency's medicine registration director Lucia Rizka Andalucia told The Jakarta Post on Thursday.
As of Oct. 4, the agency had instructed a pharmacy firm, PT Phapros Tbk or PEHA, to stop the production and distribution of its ranitidine injection products found to have been contaminated with an unhealthy amount of NDMA as well as recall its products already in the market.
PEHA said in a statement on Oct. 8 that it had recalled its ranitidine injection products following BPOM's instruction since Oct. 3, and it had also stopped production and distribution of said products since Sept. 25 after consulting with the agency.
