"The health impact on patients is judged to be not significant"
[Asia Economy Reporter Kim Ji-hee] Impurities have been detected in pharmaceuticals containing the tuberculosis treatment drug 'Rifampicin.' However, the authorities have decided to temporarily allow distribution, judging that the health impact on patients is not significant.
On the 21st, the Ministry of Food and Drug Safety announced that impurities (MNP, 1-methyl-4-nitrosopiperazine) were detected after collecting and testing a total of 10 items, including 9 finished pharmaceutical products (3 companies) and 1 raw material pharmaceutical product (1 company) containing Rifampicin, a tuberculosis treatment drug. The detected impurity MNP is a nitrosamine compound, similar to NDMA (N-nitrosodimethylamine). Since there is no carcinogenicity evaluation data for this substance, the Ministry of Food and Drug Safety has set provisional management standards by applying NDMA evaluation data through consultation with the Central Pharmaceutical Affairs Deliberation Committee.
Last year, after MNP was detected exceeding the provisional management standard (0.16 ppm) in some Rifampicin-containing pharmaceuticals in the United States, the Ministry of Food and Drug Safety began collecting and testing domestic products from September last year to verify their safety. As a result, it was confirmed that MNP exceeded the provisional management standard in all Rifampicin-containing pharmaceuticals distributed domestically.
The MNP content in finished pharmaceuticals ranged from 1.68 ppm to 6.07 ppm. Although this exceeds the provisional management standard, it is similar to the U.S. 'distribution allowable limit' (5 ppm). The U.S. allows distribution by setting allowable limits considering the shortage of these essential tuberculosis treatment drugs and accessibility.
Accordingly, the Ministry of Food and Drug Safety, after expert consultation, decided to temporarily allow manufacturing and sales of products with MNP content exceeding the provisional management standard if the content is 2.1 ppm or less. This decision was made considering that Rifampicin is an essential drug for life-threatening tuberculosis treatment with no alternative drugs, and that the human impact assessment results show minimal health effects. The situation where major countries allow the distribution of Rifampicin was also reflected.
Furthermore, the Ministry of Food and Drug Safety believes that Rifampicin-containing pharmaceuticals exceeding the provisional management standard will not have a significant health impact on most patients.
According to the Ministry of Food and Drug Safety, the human impact assessment, assuming a maximum daily dose of Rifampicin (600 mg) taken for less than one year, showed an additional cancer occurrence possibility of '0.29 per 100,000 people.' According to international guidelines in the pharmaceutical field (ICH M7), an additional cancer occurrence possibility of less than 1 per 100,000 people is considered negligible.
The Ministry of Food and Drug Safety urged, "Tuberculosis patients taking Rifampicin should not arbitrarily stop taking the medication even if they have health concerns, and must consult with the prescribing medical staff."
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