"31 Diabetes Drugs 'Carcinogenic Concern' Sales Suspended... 'Minimal Risk'" (Comprehensive)

[Asia Economy Reporter Cho Hyun-ui] Among diabetes medications containing the ingredient metformin distributed domestically, 31 products were found to contain carcinogenic substances and have been suspended from sale. Health authorities have temporarily halted the manufacturing and sales of these products and restricted their prescriptions.

On the 26th, the Ministry of Food and Drug Safety announced that after collecting and testing all raw materials and finished metformin drugs distributed domestically, NDMA (N-Nitrosodimethylamine), a probable carcinogen, was detected exceeding the control standard in 31 out of 288 finished drug products. All were domestic products, and no imported products exceeded the standards.

No NDMA exceeding the standard was detected in the raw materials. All 973 batch numbers of raw materials used in the manufacture of finished drugs were confirmed to be below the provisional control standard for NDMA (0.038 ppm). NDMA was not detected in 963 batches, and 10 batches were at the quantification limit level.

NDMA is a probable carcinogen designated by the International Agency for Research on Cancer (IARC) under the World Health Organization (WHO). It caused a stir when detected in valsartan-based blood pressure medications in 2018 and ranitidine-based stomach medications last year.

The Ministry of Food and Drug Safety has temporarily suspended the manufacturing and sales of the 31 drugs with excessive NDMA detection and restricted their prescriptions. The Ministry of Health and Welfare has taken measures to prevent these drugs from being prescribed and dispensed at hospitals and pharmacies.

From midnight on the same day, prescriptions and dispensing of these drugs at medical institutions and pharmacies were blocked through the Drug Utilization Review (DUR) system, and health insurance benefits were also suspended.

A total of 262,466 patients are currently taking the problematic drugs. However, even for those who took these products, the risk of harm to the human body is explained to be very low, at a level of "0.21 persons per 100,000."

According to the Ministry of Food and Drug Safety's human impact assessment, the probability of developing additional cancer from taking these products is 0.00021% (0.21 persons per 100,000). The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) considers it negligible if additional cancer cases occur in 1 person per 100,000.

In other words, even with long-term use, the risk of harm to the human body is almost none. The Ministry of Food and Drug Safety urged, "The possibility of additional cancer occurrence in patients who took these products is very low," and advised, "Do not stop taking the medication arbitrarily without consulting a doctor or pharmacist."

This inspection was conducted as the Ministry of Food and Drug Safety has been checking the possibility of NDMA detection in drugs distributed domestically since last year. Especially after reports of NDMA detection and recalls of metformin drugs overseas, such as in Singapore in December last year, the Ministry also conducted an investigation.

The Ministry of Food and Drug Safety estimates that the cause of NDMA detection in metformin stems from the finished drug manufacturing process. Unlike the cases of valsartan and ranitidine, the raw materials are below the standard.

The Ministry will form a "Committee to Investigate the Causes of NDMA Occurrence in Pharmaceuticals" with related experts to accurately investigate and analyze the cause. The government also plans to improve systems to minimize patient inconvenience and cost burdens in case of safety incidents caused by pharmaceuticals contaminated with impurities such as NDMA.

Additionally, the Ministry intends to thoroughly manage impurity occurrence assessments, testing, and inspections currently conducted by pharmaceutical companies themselves and to continuously expand on-site inspections of overseas manufacturing sites.

This content was produced with the assistance of AI translation services.