Topical steroid containing combinations: Burden of adverse effects and why the recent regulatory action may not be enough
Publication details: Mumbai Wolter Kluwer 2021Edition: Vol.53(5), Sep-OctDescription: 371-376pSubject(s): Online resources: In: Indian Journal of PharmacologySummary: OBJECTIVES AND METHODS: 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. RESULTS: 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. CONCLUSION: Nearly half of the cutaneous adverse effects were due to topical steroid combinations which are still widely available over the counter| Item type | Current library | Status | Barcode | |
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School of Pharmacy Archieval Section | Not for loan | 2021-2022676 |
OBJECTIVES AND METHODS: 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.
RESULTS: 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.
CONCLUSION: Nearly half of the cutaneous adverse effects were due to topical steroid combinations
which are still widely available over the counter
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