DOI: http://dx.doi.org/10.18203/issn.2455-4529.IntJResDermatol20172202

Comparative evaluation of adverse drug reactions in patients of acne prescribed with either topical benzyl peroxide or retinoic acid in a tertiary care teaching hospital

Ishan Pandya, Purna Pandya, Neha Pethani, Rima Bharatbhai Shah

Abstract


Background: To evaluate and compare the profile of adverse drug reaction, its causality, severity and preventability in patients of acne prescribed with either topical benzyl peroxide or topical retinoic acid in a tertiary care teaching hospital.

Methods: Two hundred patients attending to dermatology department with acne and prescribed with either topical benzyl peroxide or topical retinoic acid were observed for occurrence of adverse drug events (ADEs). ADEs were either spontaneously reported or elucidated from personal interviews and analyzed.

Results: Out of total 200 patients, 110 (55%) were given benzoyl peroxide gel (2.5%) and remaining 90 (45%) were given retinoic acid cream (0.025%). Total 54 adverse events were reported in 47 (23.5%) patients. Highest number of patients having ADR was from 16-20 years (35, 74.46%) with male predominance (59.57%). Number of adverse events reported was significantly higher (p <0.05) in retinoic acid group (34, 62.96%) as compare to benzyl peroxide group (20, 37.03%). Most common ADRs were exfoliation (14, 25.92%) and burning sensation (13, 24.07%). Most of the ADRs fell in category of ‘probable’ and ‘possible’ in causality assessment by both WHO-UMC method and Narenjo’s scale. All the ADRs were of mild (44, 81.48%) and moderate (10, 18.52%) severity. Majority of ADRs were not preventable (24, 44.44%) followed by definitely preventable 22(40.74%) and 8 (14.81%) probably preventable.

Conclusions: ADRs is a common problem associated with topically used medications for acne and its occurrence is significantly higher with retinoic acid as compare to benzyl peroxide. Early diagnosis and proper education about use of topical drugs can prevent some of the ADRs. 


Keywords


Acne vulgaris, Retinoic acid, Benzyl peroxide, Adverse drug reactions, Causality assessment of ADRs, Severity and preventability of ADRs

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References


Dudhiya S, Shah RB, Agrawal P, Shah A, Date S. Efficacy and safety of clindamycin gel plus either benzoyl peroxide gel or adapalene gel in the treatment of acne: a randomized open-label study. Drugs Ther Perspect. 2015;31(6):208-12.

Ebling FJG, Cunliffe WJ. Disorders of the sebaceous glands. In: Champion RH, Burton JL, Burns DA, Breathnach SM, editors. 6th edition, Textbook of Dermatology. Volume 3. Oxford: Blackwell Science; 1998: 1942.

Niemeier V1, Kupfer J, Demmelbauer-Ebner M, Stangier U, Effendy I, Gieler U. Coping with acne vulgaris. Evaluation of the chronic skin disorder questionnaire in patients with acne. Dermatology. 1998;196:108-15.

Cunliffe WJ. Acne and unemployment. (Letter.) Br J Dermatol. 1986;115:386.

Dipiro JT, Talbert RL, Yee GC. Pharmacotherapy: a pathophysiologic approach. 6th edition. South Carolina: The McGraw-Hill Companies; 2008.

Rathi SK. Acne vulgaris treatment: the current scenario. Indian J Dermatol. 2011;56(1):7–13.

World Health Organization (WHO). The importance on pharmacovigilance. Safety monitoring on medicinal products. Geneva: Office of Publications, World Health Organization; 2002.

Tutakne MA, Chari KVR. Acne, rosacea and perioral dermatitis. In: Valia RG, Valia AR, editors. IADVL textbook and atlas of dermatology, 2nd edn. Mumbai: Bhalani publishing House; 2003: 689–710.

World Health Organization (WHO). The Importance on Pharmacovigilance. Safety Monitoring on Medicinal Products. Geneva (Switzerland): Office of Publications, World Health Organization; 2002.

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45.

Hartwing SC, Siegel J, Schnelder PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Lau PM, Stewart K, Dooley MJ. Comment: hospital admissions resulting from preventable adverse drug reactions. Ann Pharmacother. 2003;37(2):303-5.

Handler SM, Wright RM, Ruby CM, Hanlon JT. Epidemiology of medication-related adverse events in nursing homes. Am J Geriatr Pharmacother. 2006;4:264-72.

Masood Ali SM, Khan M, Samdani AJ, Siddiqui A. Study to assess the effect of topical clindamycin gel in acne vulgaris. Pakistan J Pharmacol. 2010;27(2):15-9.

Schmidt N, Gans EH. Clindamycin 1.2% Tretinoin 0.025% Gel versus Clindamycin Gel Treatment in Acne Patients. J Clin Aesthet Dermatol. 2011;4(6):31–40.

Shah RB, Gajjar BM, Desai S. A profile of adverse drug reactions with risk factors among geriatric patients in a tertiary care teaching rural hospital in India. Natl J Physiol Pharm Pharmacol. 2012;2:113-22.

Sharma M, Gupta SK, Gupta VB, Chatterjee. A comparative study of Causality Assessment Scales used in the analysis of spontaneously reported events: WHO-UMC criteria vs Narenjo probability scale. J Pharmacovigilance Drug Safety. 2009;6(1):5-9.

Bates DW, Cullen DJ, Laird N, Peterson LA, Small AD, Servi D, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE prevention study group. J Am Med Assoc. 1995;274(1):29-34.

Ducharme MM, Boothby LA. Analysis of adverse drug reactions for preventability. Int J Clin Pract. 2007;61(1):157–61.

Dean B, Schachter M, Vincent C, Barber N. Causes of prescribing errors in hospital inpatients: a prospective study. Lancet. 2002;359:1373-8.