Collective exposure to lead from an approved natural product-derived drug in Korea

BACKGROUND: In Asian countries, including Korea, lead poisoning caused by traditional herbal medicines is often observed in the clinic. However, there have been no reports thus far of lead poisoning caused by drugs that were approved by the Korea Food and Drug Administration (KFDA). Here, we describe seven patients who ingested a problematic natural product-derived drug (NPD). CASE PRESENTATION: In July 2018, seven patients visited a university hospital after ingesting an NPD, S. capsules. These patients complained of various symptoms, and their blood lead levels (BLLs) were elevated relative to those of the general population (arithmetic mean: 19.5 ± 11.6 µg/dL, range: 6.28–35.25 µg/dL). The total doses and BLLs were directly proportional to each other among the patients (r = 0.943, p = 0.001). After the patients discontinued drug intake, their BLLs decreased gradually. The capsule was confirmed to contain lead above the standard value (arithmetic mean: 2,547 ± 1,821.9 ppm). CONCLUSION: This incident highlights the need to strengthen standards for the management of NPD ingredients in Korea. NPDs are more likely to be contaminated than other drugs. Thorough management by the KFDA is essential to prevent a recurrence. Moreover, systematic health care is needed for many patients who have taken problematic NPDs.