Background: Isotretinoin has been proven to be an effective treatment for acne vulgaris. The enclosed package insert with isotretinoin suggests weekly/biweekly laboratory testing (hepatic functions and lipid analysis) but fails to recommend the needed action levels for abnormalities. Methods: We provide a statistical analysis of a retrospective study of 141 individuals’ course of therapy on isotretinoin and their laboratory blood analysis results. Results: Very few statistically significant elevations in liver enzymes or lipid profiles occurred. More importantly, in only 1 case did these elevations warrant the discontinuation of therapy. Conclusion: The data presented here support the conclusion that limited blood testing should be performed for most patients and that more complete blood testing be done only for those patients with a significant response in liver enzymes, cholesterol or triglycerides. A set of guidelines is proposed for the practicing physician to interpret blood test results.

1.
Strauss JS, Leyden JJ, Lucky AW, Lookingbill DP, Drake LA, Hanifin JM, Lowe NJ, Jones TM, Stewart DM, Jarratt MT, Katz I, Pariser DM, Pariser RJ, Tschen E, Chalker DK, Rafal ES, Savin RP, Roth HL, Chang LK, Baginski DJ, Kempers S, McLane J, Eberhardt D, Leach EE, Bryce G, Hong J: Safety of a new micronized formulation of isotretinoin in patients with severe recalcitrant nodular acne: A randomized trial comparing micronized isotretinoin with standard isotretinoin. J Am Acad Dermatol 2001;45:196–207.
2.
Meadows M: The power of Accutane: The benefits and risks of a breakthrough drug. FDA Consumer 2001;35:18–23.
3.
Citrome L: Safety of Accutane with possible depression. Postgrad Med 1998;104:38.
4.
Tamai H: Vitamin A toxicity and neurological findings. Ryoikibetsu Shokogun Shirizu 2000;29:119–120.
5.
Prokop LD: Isotretinoin: Possible component cause of inflammatory bowel disease. Am J Gastroenterol 1999;94:2568.
6.
Mantel-Teeuwisse AK, Kloosterman JM, Maitland-van der Zee AH, Klungel OH, Porsius AJ, de Boer A: Drug-induced lipid changes: A review of the unintended effects of some commonly used drugs on serum lipid levels. Drug Safety 2001;24:443–456.
7.
Brandt JR, Mick TJ: Extraspinal enthesopathy caused by isotretinoin therapy. J Manipulative Physiol Ther 1999;22:417–420.
8.
Steele RG, Lugg P, Richardson M: Premature epiphyseal closure secondary to single-course vitamin A therapy. J Surg 1999;69:825–827.
9.
Goulden V, Layton AM, Cunliffe WJ: Long-term safety of isotretinoin as a treatment for acne vulgaris. Br J Dermatol 1994;131:360–363.
10.
Warren KJ, Cruz PD: Clinical outcome and cost analysis of isotretinoin versus conventional regimens in the treatment of moderate acne vulgaris in male patients. Pediatr Dermatol 1998;15:329–331.
11.
Lehucher-Ceyrac D, Weber-Buisset MJ: Isotretinoin and acne in practice: A prospective analysis of 188 cases over 9 years. Dermatology 1993;186:123–128.
12.
Layton AM, Knaggs H, Taylor J, Cunliffe WJ: Isotretinoin for acne vulgaris – Ten years later. A safe and successful treatment. Br J Dermatol 1993;129:292–296.
13.
Stainforth JM, Layton AM, Taylor JP, Cunliffe WJ: Isotretinoin for the treatment of acne vulgaris: Which factors may predict the need for more than one course? Br J Dermatol 1993;129:297–301.
14.
Lester RS, Schachter GD, Light MJ: Isotretinoin and tetracycline in the management of severe nodulocystic acne. Int J Dermatol 1985;24:252–257.
15.
Cunliffe WJ, van der Kerkhof PC, Caputo R, Cavicchini S, Cooper A, Fyrand OL, Gollnick H, Layton AM, Leyden JJ, Mascaro JM, Ortonne JP, Shalita A: Roaccutane treatment guidelines: Results of an international survey. Dermatology 1997;194:351–357.
16.
Ortonne JP: Oral isotretinoin treatment policy: Do we all agree? Dermatology 1997;195(suppl 1): 34–37, discussion 38–40.
17.
Layton AM, Cunliffe WJ: Guidelines for optimal use of isotretinoin in acne. J Am Acad Dermatol 1992;27(6 pt 2):S2–S7.
18.
Nelle DM, Buytenhek R, Staels B, Dallongeville J, Wallnofer AE, Kooistra T, Princen HMG: No short-term effect of oral isotretinoin (13-cis-retinoic acid) on lipoprotein(a) and HDL subclasses LP-A-I and LP-AI:A-II in healthy volunteers. J Intern Med 1999;246:120–122.
19.
Honein MA, Paulozzi LJ: Cost-effectiveness of oral isotretinoin. Dermatology 1999;198:404–406.
20.
Nightingale SL: From the Food and Drug Administration. JAMA 1998;279:984.
21.
Saurat JH: Oral isotretinoin: Where now, where next? Dermatology 1997;195(suppl 1):1–3, discussion 38–40.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.