Neuropathic pain medications are often administered for prolonged periods, thus their long-term safety is important. We conducted a post-marketing surveillance for mirogabalin in patients with peripheral neuropathic pain, to investigate incidences of diabetes mellitus (DM: aggravation, development), vision disorders, hypoglycemia, sudden deaths, and other adverse events (AEs) during 12 months of starting mirogabalin treatment. The safety analysis set included 1,519 patients; 259 with DM and 1,260 without DM. Of the 660 patients who continued treatment, 424 (64.2%) did not reach the effective dose according to the package insert, with six of these cases (1.4%) due to AEs. Of the 859 patients who discontinued treatment, 66 (7.7%) discontinued due to AEs. Incidences of DM (aggravation, development), and vision disorders were 4.25% (11/259), 0.08% (1/1,260), and 0.07% (1/1,519), respectively. No hypoglycemia or sudden deaths occurred. In this surveillance on long-term mirogabalin treatment, no new safety concerns regarding DM (aggravation, development), vision disorders, hypoglycemia, sudden deaths, or other AEs were observed.
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