Overview on desonide 0.05%: a clinical safety profile.
Desonide (as a cream, ointment, or lotion formulation) is widely used for the treatment of steroid-responsive dermatoses. This paper provides information on its safety record, as determined from adverse event reports and published trial results. A pharmacovigilance program, initiated in 1992 for all countries where desonide is available, collected reports of adverse events associated with topical desonide over nine years. Published accounts of randomized, controlled trials of desonide in comparison with hydrocortisone were reviewed. Sixty-two reports have been collected; most were from consumers and were not medically substantiated. There were no serious reactions directly attributable to desonide treatment and the majority of events reported were classified as expected local reactions, generally mild in nature. This level of reporting is against a background of extensive prescribing of desonide; almost one million packs are dispensed per annum in the US alone. The excellent safety profile of desonide revealed by this pharmacovigilance program is supported by a review of published clinical trial results.
Wong
Vicky Kwan
VK
Department of Dermatology, Mount Sinai Medical Center, New York, NY 10029-6574, USA. sinaiderm@aol.com
Fuchs
Brian
B
Lebwohl
Mark
M
D000279:Administration, Cutaneous; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002986:Clinical Trials as Topic; D003872:Dermatitis / Q000188:drug therapy*; D012628:Dermatitis, Seborrheic / Q000188:drug therapy; D003898:Desonide / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004342:Drug Hypersensitivity / Q000209:etiology; D004890:Erythema / Q000139:chemically induced; D005128:Eye Diseases / Q000139:chemically induced; D006801:Humans; D009824:Ointments; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D012867:Skin / Q000187:drug effects
D000893:Anti-Inflammatory Agents; D009824:Ointments; D003898:Desonide