Department of Pharmacology, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India.
Department of Dermatology, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India.
Indian J Pharmacol. 2021 Sep-Oct;53(5):371-376. doi: 10.4103/ijp.IJP_728_19.
In September 2018, the government of India banned 328 fixed dose combinations (FDCs), 24 of which are combinations containing topical steroids. To assess what impact can be expected from this regulatory action, we analyzed reports of adverse drug events due to topical corticosteroids at a hospital-based pharmacovigilance center between January 2017 and August 2018.
Among 34 different steroid-containing FDCs responsible for 485 reports of ADEs with topical steroids, only three preparations, accounting for 50.10% of ADEs, come under the umbrella of the recent ban. Clobetasone propionate (68.87%) and betamethasone (28.45%) were the corticosteroids most frequently associated with adverse events. Most of the steroid preparations (87.84%) had been bought without a prescription for the treatment of dermatophytoses (76.70%). Males (77.73%) were predominantly affected, and nearly half (47.43%) of the patients were between 21 and 30 years of age. Skin atrophy (50.10%), striae (25.54%), and hypopigmentation (19.79%) were the major ADEs.
Nearly half of the cutaneous adverse effects were due to topical steroid combinations which are still widely available over the counter.
2018 年 9 月，印度政府禁止了 328 种固定剂量组合（FDC），其中 24 种是含有局部皮质类固醇的组合。为了评估这一监管行动可能产生的影响，我们分析了 2017 年 1 月至 2018 年 8 月间一家医院药物警戒中心因局部皮质类固醇引起的药物不良反应报告。
在导致 485 例与局部类固醇相关的 ADE 报告的 34 种不同的含有皮质类固醇的 FDC 中，只有三种制剂（占 ADE 的 50.10%）属于最近禁令的范围。丙酸氯倍他索（68.87%）和倍他米松（28.45%）是最常与不良事件相关的皮质类固醇。大多数皮质类固醇制剂（87.84%）是未经处方购买的，用于治疗皮肤癣病（76.70%）。男性（77.73%）受影响居多，近一半（47.43%）的患者年龄在 21 至 30 岁之间。皮肤萎缩（50.10%）、条纹（25.54%）和色素减退（19.79%）是主要的 ADE。
近一半的皮肤不良反应是由于局部皮质类固醇组合药物仍然广泛在柜台出售所致。
