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BPOM takes stomach drugs off market over cancer risk
The 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
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span>The 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 nanograms. 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.
BPOM head Penny Kusumastuti Lukito told a press briefing on Friday that the agency had decided to recall all ranitidine products and asked the pharmacy industry to stop all production, distribution and sales of the products.
The pharmaceutical industry was given 80 days to recall the products since Wednesday, she said. The decision was made following the agency's finding that from the 10 assessed brands, six were found to have contained NDMA that exceeded the limited amount.
PEHA said in a statement last Tuesday 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.
Three other pharmacy firms have voluntarily recalled their products as of Oct. 4, namely PT Glaxo Wellcome Indonesia with its Zantac injection products, PT Global Multi Pharmalab with its Rinadin syrup and PT Indofarma with its Indoran and Ranitidine injections, the agency said.
"As a form of responsibility by the pharmaceutical industry in ensuring the quality and safety of the medicines it produces and distributes, the industry is required to independently conduct tests on whether its products have been contaminated with NDMA and to voluntarily recall its products if the amount exceeds the permitted limit," the BPOM said in its statement.
Lucia said the agency had previously found that NDMA had also contaminated some antihypertension products in the angiotensin receptor blocker (ARB) group, namely Losartan and Valsartan. The agency then recalled the products, she said, but they could be used again after the producers had resorted to using other ingredients proven to be safe.
She added that the agency routinely conducted risk-based post-market assessments on impurities under international pharmacopoeia standards.
"For the NDMA impurities, the assessment method was just discovered, so all drug regulatory bodies in the world only recently adopted it, including the FDA and EMA," she said.
Indonesian Doctors Association (IDI) chairman-elect Mohammed Adib Khumaidi said ranitidine was widely used in Indonesia and was commonly found at first-level health facilities, such as clinics and community health centers (Puskesmas) as it was more affordable than other products meant to decrease the production of gastric acid.
Adib said there were alternatives that were more effective for treating the same diseases, although at a higher price, noting however that they could still be covered under the National Health Insurance (JKN) scheme.
"The cause of cancer can depend on multiple factors. NDMA consumption doesn't necessarily and certainly lead to cancer [...] However, it's better to avoid it," he said on Wednesday.
He went on to say the recall should also act as an input for the BPOM to be more proactive in conducting post-market research to ensure the quality and safety of products sold, although he acknowledged that the findings of the FDA and EMA should act as the basis for BPOM's decisions.
"The FDA's post-marketing survey and research is even more active [than the BPOM’s] because there is better research support there," he said.
Indonesian Consumers Foundation (YLKI) chairman Tulus Abadi urged the BPOM, industry and the health and pharmacy professionals to keep themselves updated with knowledge, research and inventions, given that both fields were dynamic with rapidly advancing research and development, to ensure consumer safety.
"What has always been allowed can turn the other way with new research findings. [...] The BPOM should be more proactive in monitoring and running lab tests on products in the market, so that the drugs that we consume won't cause side effects due to slow research and development from the government or the BPOM and the pharmacy industry." he said.
