Revisiting the Safety of Prostaglandin Analog Eyelash Growth Products.
Journal
Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.]
ISSN: 1524-4725
Titre abrégé: Dermatol Surg
Pays: United States
ID NLM: 9504371
Informations de publication
Date de publication:
01 05 2021
01 05 2021
Historique:
pubmed:
25
2
2021
medline:
14
9
2021
entrez:
24
2
2021
Statut:
ppublish
Résumé
The FDA approved bimatoprost ophthalmic solution 0.03% for treatment of eyelash hypotrichosis in 2008. Consumer concern persists regarding potential side effects of this product. To identify gaps in the safety information associated with the use of prostaglandin eyelash growth products. Literature searches were performed using PubMed, Embase, and Nexis Uni databases without restriction to publication date, language, or study setting. The literature pertaining to bimatoprost for treatment of eyelash hypotrichosis is dominated by industry-sponsored clinical trials. Study design choices create gaps in our understanding of the clinical safety of these products. Because of study design choice, clinical trials of bimatoprost for eyelash growth may have systematically underreported the incidence of drug application discomfort and prostaglandin-associated periorbitopathy. The risk of increased iris pigmentation remains inadequately investigated. Consequently, there is an ongoing need to educate and monitor patients who choose to use these products.
Sections du résumé
BACKGROUND
The FDA approved bimatoprost ophthalmic solution 0.03% for treatment of eyelash hypotrichosis in 2008. Consumer concern persists regarding potential side effects of this product.
OBJECTIVE
To identify gaps in the safety information associated with the use of prostaglandin eyelash growth products.
MATERIALS AND METHODS
Literature searches were performed using PubMed, Embase, and Nexis Uni databases without restriction to publication date, language, or study setting.
RESULTS
The literature pertaining to bimatoprost for treatment of eyelash hypotrichosis is dominated by industry-sponsored clinical trials. Study design choices create gaps in our understanding of the clinical safety of these products.
CONCLUSION
Because of study design choice, clinical trials of bimatoprost for eyelash growth may have systematically underreported the incidence of drug application discomfort and prostaglandin-associated periorbitopathy. The risk of increased iris pigmentation remains inadequately investigated. Consequently, there is an ongoing need to educate and monitor patients who choose to use these products.
Identifiants
pubmed: 33625141
doi: 10.1097/DSS.0000000000002928
pii: 00042728-202105000-00020
doi:
Substances chimiques
Antihypertensive Agents
0
Nonprescription Drugs
0
Ophthalmic Solutions
0
Prostaglandins, Synthetic
0
Bimatoprost
QXS94885MZ
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
658-665Informations de copyright
Copyright © 2021 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
Références
FDA. FDA Warns Maker of Latisse About Misleading Claims. Consumer Reports. Available from: https://www.consumerreports.org/cro/news/2009/09/fda-warns-maker-of-latisse-about-misleading-claims/index.htm . Accessed September 17, 2009.
Long Lashes Without Prescription, But With Risks. Saint Louis, MI: New York Times; 2020. Available from: https://www.nytimes.com/2010/05/02/health/02latisse.html . Accessed May 3, 2010.
Food and Drug Administration. Pediatric postmarketing pharmacovigilance and drug utilization review. Available from: https://www.fda.gov/media/107002/download . Accessed June 5, 2017.
Swedish Medical Products Agency. Long Eyelashes—Good Looking at What Price. Informatics From the Swedish Medical Products Agency. Available from: https://lakemedelsverket.se/upload/om-lakemedelsverket/publikationer/information-fran-lakemedelsverket/2013/Info%20från%20LV%20nr%205_2013_webb.pdf . Accessed October 4–7, 2013.
Johnstone MA, Albert DM. Prostaglandin-induced hair growth. Surv Ophthalmol 2002;47:185–202.
Stern FA, Bito LZ. Comparison of the hypotensive and other ocular effects of prostaglandins E2 and F2a on cat and rhesus monkey eyes. Invest Ophthalmol Vis Sci 1982;22:588–98.
Nilsson SF, Samuelsson M, Bill A, Stjernschantz J. Increased uveoscleral outflow as a possible mechanism of ocular hypotension caused by prostaglandin F2a-1-isopropylester in the cynomolgus monkey. Exp Eye Res 1989;48:707–16.
Stjernschantz JW. From PGF2a-isopropyl ester to latanoprost: a review of the development of Xalatan. The proctor lecture. Invest Ophthalmol Vis Sci 2001;42:1134–45.
Perry CM, McGavin JK, Culy CR, Ibbotson T. Latanoprost: an update of its use in glaucoma and ocular hypertension. Drugs Aging 2003;20:597–630.
Tafluprost (zioptan)—a new topical prostaglandin for glaucoma. Med Lett Drugs Ther 2012;54:36.
March B. The scary lash growth drops that turn green eyes brown. Cosmopolitan. Avaialble from: https://www.cosmopolitan.com/uk/beauty-hair/news/a34583/lash-growth-drops-change-eye-colour/ . Accessed March 31, 2015.
Wistrand PJ, Stjernschantz J, Olsson K. The incidence and timecourse of latanoprost-induced iridial pigmentation as a function of eye color. Surv Ophthalmol 1997;41(Suppl 2):S129–38.
Teus MA, Arranz-Marquez E, Lucea-Suescu P. Incidence of iris colour change in latanoprost treated eyes. Br J Ophthalmol 2002;86:1085–8.
Chiba T, Kashiwagi K, Chiba N, Ishijima K, et al. Comparison of iridial pigmentation between latanoprost and isopropyl unoprostone: a long term prospective comparative study. Br J Ophthalmol 2003;87:956–9.
Inoue K, Shikawa M, Sugahara M, Higa R, et al. Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension. Clin Ophthalmol 2012;6:111–6.
Camras CB, Neely DG, Weiss EL. Latanoprost-induced iris color darkening: a case report with long-term follow-up. J Glaucoma 2000;9:95–8.
Friedman DS, Hahn SR, Gelb L, Tan J, et al. Doctor-patient communication, health-related beliefs, and adherence in glaucoma results from the glaucoma adherence and persistency study. Ophthalmology 2008;115:1320–7.
Warwar RE, Bullock JD, Ballal D. Cystoid macular edema and anterior uveitis associated with latanoprost use. Experience and incidence in a retrospective review of 94 patients. Ophthalmology 1998;105:263–8.
Woodward JA, Haggerty CJ, Stinnett SS, Williams ZY. Bimatoprost 0.03% gel for cosmetic eyelash growth and enhancement. J Cosmet Dermatol 2010;9:96–102.
Alm A, Grierson I, Shields MB. Side effects associated with prostaglandin analog therapy. Surv Ophthalmol 2008;6:S93–105.
Peplinski LS, Albiani Smith K. Deepening of lid sulcus from topical bimatoprost therapy. Optom Vis Sci 2004;81:574–7.
Serrero G, Lepak NM. Prostaglandin F2a receptor (FP receptor) agonist are potent adipose differentiation inhibitors for primary culture of adipocyte precursors in defined medium. Biochem Biophys Res Commun 1997;233:200–2.
Filippopoulos T, Paula JS, Torun N, Hatton MP, et al. Periorbital changes associated with topical bimatoprost. Ophthalmic Plast Reconstr Surg 2008;24:302–7.
Tappeiner C, Perren B, Iliev ME, Frueh BE, et al. Orbital fat atrophy in glaucoma patients treated with topical bimatoprost—can bimatoprost cause enophthalmos? Klin Monbl Augenheilkd 2008;225:443–5.
Park J, Cho HK, Moon JI. Changes to upper eyelid orbital fat from use of topical bimatoprost, travoprost, and latanoprost. Jpn J Ophthalmol 2011;55:22–7.
Inoue K, Shiokawa M, Wakaura M, Tomita G. Deepening of the upper eyelid sulcus caused by 5 types of prostaglandin analogs. J Glaucoma 2013;22:626–31.
Aihara M, Shirato S, Sakata R. Incidence of deepening of the upper eyelid sulcus after switching from latanoprost to bimatoprost. Jpn J Ophthalmol 2011;55:600–4.
Sakata R, Shirato S, Miyata K, Aihara M. Recovery from deepening of the upper eyelid sulcus after switching from bimatoprost to latanoprost. Jpn J Ophthalmol 2013;57:179–84.
Custer PL, Kent TL. Observations on prostaglandin orbitopathy. Ophthalmic Plast Reconstr Surg 2016;32:102–5.
Kent TL, Custer PL. Structural and histologic eyelid changes associated with 6 months of topical bimatoprost in the rabbit. J Glaucoma 2017;26:253–7.
Goh AS, Nassiri N, Kohn JC, Rootman DB, et al. Prostaglandin eyedrops are associated with decreased thicknesses of eyelid dermis and orbicularis oculi muscle: ultrasonographic findings. Ophthalmic Plast Reconstr Surg 2016;32:337–41.
Shah M, Lee G, Lefebvre G, Kronberg B, et al. A cross-sectional survey of the association between bilateral topical prostaglandin analogue use and ocular adnexal features. PLoS One 2013;8:e61638.
Fong CS, Pajak SN, Pirbhai A, Selva D. Audible clink in prostaglandin-associated periorbitopathy. Clin Exp Ophthalmol 2016;44:630–1.
Skorin L, Dailey KH. Clicking eyelids: a new finding of prostaglandin-associated periorbitopathy. Optom Vis Sci 2016;93:779–81.
Lee TH, Sung MS, Heo H, Park SW. Association between meibomian gland dysfunction and compliance of topical prostaglandin analogs in patients with normal tension glaucoma. PLoS One 2018;13:e0191398.
Cunniffe MG, Medel-Jimenez R, Gonzalez-Candial M. Topical antiglaucoma treatment with prostaglandin analogues may precipitate meibomian gland disease. Ophthalmic Plast Reconstr Surg 2011;27:e128–9.
Yoelin S, Walt JG, Earl M. Safety, effectiveness, and subjective experience with topical bimatoprost 0.03% for eyelash growth. Dermatol Surg 2010;36:638–49.
Dang J, Cole JC, Burgess SM, Yang M, et al. Development and validation of the eyelash satisfaction questionnaire. Aesthet Surg J 2016;36:221–8.
Smith S, Fagien S, Whitcup SM, Ledon F, et al. Eyelash growth in subjects treated with bimatoprost: a multicenter, randomized, double-masked, vehicle-controlled, parallel-group study. J Am Acad Dermatol 2012;66:801–6.
Wirta D, Pariser DM, Yoelin SG, Arase S, et al. Bimatoprost 0.03% for the treatment of eyelash hypotrichosis: a pooled safety analysis of six randomized, double-masked clinical trials. J Clin Aesthet Dermatol 2015;8:17–29.
Glaser DA, Hossain P, Perkins W, Griffiths T, et al. Long-term safety and efficacy of bimatoprost solution 0.03% application to the eyelid margin for the treatment of idiopathic and chemotherapy-induced eyelash hypotrichosis: a randomised controlled trial. Br J Dermatol 2015;172:1384–94.
Cohen JL. Enhancing the growth of natural eyelashes: the mechanism of bimatoprost-induced eyelash growth. Dermatol Surg 2010;36:1361–71.
Fagien S. Management of hypotrichosis of the eyelashes: focus on bimatoprost. Clin Cosmet Invest Dermatol 2010;3:39–48.
Jones D. Enhanced eyelashes: prescription and over-the-counter options. Aesthet Plast Surg 2011;35:116–21.
Higginbotham EJ, Schuman JS, Goldberg I, Gross RL, et al.; For the Bimatoprost Study Groups 1 and 2. One-year, randomized study comparing bimatoprost and timolol in glaucoma and ocular hypertension. Arch Ophthalmol 2002;120:1286–93.
Zaleski-Larsen LA, Ruth NH, Fabi SG. Retrospective evaluation of topical bimatoprost and iris pigmentation change. Dermatol Surg 2017;43:1431–3.
Ratner D, Thomas CO, Bickers D. The use of digital photography in dermatology. J Am Acad Dermatol 1999;41:749–56.
Australian Government, Department of Health, Therapeutic Goods Administration. Australian Public Assessment Report for Bimatoprost. Available from: https://www.tga.gov.au/sites/default/files/auspar-bimatoprost-140718.pdf . Accessed June 10, 2014.
Brown RH, Hotchkiss ML, Davis EB. Creating smaller eyedrops by reducing eyedropper tip dimensions. Am J Ophthalmol 1985;99:460–4.
FDA adverse events reporting system (FAERS) public dashboard. Available from: https://fis.fda.gov/sense/app/d10be6bb-494e-4cd2-82e4-0135608ddc13/sheet/7a47a261-d58b-4203-a8aa-6d3021737452/state/analysis . Accessed June 3, 2020.
Lipp MB, Athalye L, Nami N. Bimatoprost-induced iris hyperpigmentation: beauty in the darkened eye of the beholder. Cutis 2019;44:E7–9.
Sarnoff DS, Gotkin RH. Bimatoprost-induced chemical blepharoplasty. J Drugs Dermatol 2015;14:472–7.
ClinicalTrials.gov [Internet]. 2017 November 8-ClinicalTrials.Gov Identifier: NCT02607683, Phase 2b/3 Study of XAF5 Ointment for Steatoblepharon (Undereye Bags). Bethesda, MD: National Library of Medicine (US); 2017. Available from: https://clinicaltrials.gov/ct2/show/NCT02607683 . Accessed April 13, 2020.
Rabinowitz MP, Katz LJ, Moster MR, Myers JS, et al. Unilateral prostalandin-associated preiorbitopathy: a syndrome involving upper eyelid retraction distinguishable from the aging sunken eyelid. Ophthal Plast Reconstr Surg 2015;31:373–8.
Awwad S, Mohamed AH, Sharma G, Heng JS, et al. Principles of pharmacology in the eye. Br J Pharmacol 2017;174:4205–23.
Alderson P. Equipose as a means of managing uncertainty: personal, communal and proxy. J Med Ethics 1996;22:135–9.
Chanasumon N, Sriphojanart T, Suchonwanit P. Therapeutic potential of bimatoprost for the treatment of eyebrow hypotrichrosis. Drug Des Devel Ther 2018;12:365–72.
The Swedish Medical Products Agency. Pharmaceutical Ingredients in One Out of Three Eyelash Serums. Available from: https://www.drjetskeultee.nl/jetskeultee/download/common/artikel-wimpers-ingredients.pdf . Accessed July 11, 2020.
Government of Canada (2019). Cosmetic Ingredient Hotlist. Available from: https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/cosmetic-ingredient-hotlist-prohibited-restricted-ingredients/hotlist.html . Accessed July 12, 2020.
FDA. Inspections, Compliance, Enforcement, and Criminal Investigations. Available from: https://wayback.archive-it.org/7993/20170111100914/http:/www.fda.gov/ICECI/EnforcementActions/WarningLetters/2011/ucm251951.htm . Accessed July 12, 2020.
Tunaru S, Althoff TF, Nusing RM, Diener M, et al. Castor oil induced laxation and uterus contraction via ricinoleic acid activating prostaglandin EP3 receptors. Proc Natl Acad Sci USA 2012;109:9179–84.