Post-marketing surveillance of zinc acetate dihydrate for hypozincemia in Japan.

Zinc is an essential microelement, and its deficit causes various diseases and symptoms. In adults, especially in elderly individuals, zinc shortage can cause symptoms such as taste disorder, dermatitis, and susceptibility to infection. In children, zinc deficiency can lead to growth retardation. In 2017, the indication for zinc acetate dihydrate (NOBELZIN®) was expanded from Wilson's disease to include hypozincemia, leading to wider use of zinc acetate dihydrate. At five years after this broadening of use, we conducted a post-marketing study (PMS) to investigate the utilization, safety, and effectiveness of zinc acetate dihydrate. Over 52 weeks, the overall incidence of adverse drug reactions (ADRs) was 9.4% (87/928). The most common ADR was copper deficiency (2.4%), followed by nausea (1.4%). Among 928 patients, 19 (2%) developed serious ADRs. Of the patients with copper deficiency, 92% were >65 years of age, and all had comorbidities at baseline. Physicians evaluated the effectiveness of zinc acetate dihydrate using three categories: "effective", "not effective", and "indeterminate". The overall efficacy rate was 83.0%. The average serum zinc levels were elevated from 50-60 µg/dL to >90 µg/dL within 12 weeks, and were maintained up to 52 weeks after administration. Among the symptomatic sub-categories, the efficacy rate was highest in pressure ulcer (96.2%; 25/26), followed by in stomatitis (87.5%; 42/48), and taste disorder (87.4%; 181/207). Among pediatric patients with developmental symptoms, an efficacy rate of 66% was achieved. In conclusion, zinc acetate dihydrate has been safely used, and has produced beneficial effects on various diseases and symptoms.

[Elution of lead and cadmium from imported gold-decorated glassware].

Lead and cadmium were known to be eluted from some imported gold-decorated glassware, which was bonded at a quarantine station. Elution of lead and cadmium was confirmed to be occurred from the gold-decorated portion, but not from glass itself. No elution of these heavy metals was observed from gold-decorated glassware in the market.

[Migration test of lead and cadmium from plastic wares in contact with food].

Release of lead and cadmium from plastic tableware was examined. Samples were treated with 2 ml of 4% acetic acid or 0.1N HCl per cm2 of the surface area at 60 degrees C or 95 degrees C for 30 min. No migration of lead and cadmium from samples containing up to 391 ppm lead or 6863 ppm cadmium was observed.

[Determination of volatile substances and leachable components in polystyrene food contact wares].

Material and migration tests of food-contact plastic wares made of polystyrene were carried out. The average concentration of volatile substances (sum of toluene, ethylbenzene, isopropylbenzene, n -propylbenzene, and styrene) in materials was 861 +/- 692 ppm. Styrene was observed in 95% of 19 samples. alpha-Methylstyrene, which is one of the material compounds of polystyrene, was detected in one sample. Release of volatile substances into n-heptane was not observed at the detection limits of 0.1 ppm.