Topical clindamycin for acne vulgaris: analysis of gastrointestinal events

Abstract

Purpose: Topical clindamycin, a lincosamide antibiotic, is commonly combined with benzoyl peroxide or a retinoid for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding gastrointestinal (GI) adverse events (AEs), real-world incidence of GI AEs with topical clindamycin is unknown. This review provides background information and an overview of safety data of topical clindamycin for treating AV.Materials and Methods: Available safety data from published literature, previously unpublished worldwide pharmacovigilance data, and two retrospective cohort studies were reviewed.Results and Conclusions: According to pharmacovigilance data, the rate of GI adverse drug reactions with topical clindamycin-containing products was 0.000045% (64/141,084,533). Results from two retrospective medical record studies of patients with AV indicated that physicians prescribe topical clindamycin equally to patients with or without inflammatory bowel disease history, and that rates of pseudomembranous colitis in these patients were low. In 8 published pivotal clinical trials of topical clindamycin for AV, GI AEs were reported in 1.4% of participants. Limitations include under/inaccurate reporting of AEs or prescription data and limited generalizability. This review of published case reports, worldwide pharmacovigilance data, retrospective US prescription data, and clinical trials safety data demonstrates that the incidence of colitis in patients exposed to topical clindamycin is extremely low.

Keywords:

• Clindamycin
• topical
• acne vulgaris
• adverse events
• colitis
• inflammatory bowel disease

Acknowledgments

Manuscript preparation support was provided by Lynn M. Anderson, Ph.D. of Prescott Medical Communications Group (Chicago, IL, USA) with financial support from Ortho Dermatologics. Pharmacovigilance data were collected and analyzed by Corina Avrigeanu, Anca Negut, and Teodora Lyuleva of Bausch Health LLC.

Author contributions

All authors made substantial contributions to the conception or design of the work; drafted the work/revised it critically; approved the version to be published; and agree to be accountable for all aspects of the work.

Disclosure statement

Natalia M. Pelet del Toro and Andrew Strunk have no conflicts of interest. Jashin Wu has served as an investigator, consultant, or speaker for AbbVie, Almirall, Amgen, Arcutis, Bausch Health US, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. Linda Stein Gold has served as investigator/consultant or speaker for Ortho Dermatologics, LEO Pharma, Dermavant, Incyte, Novartis, AbbVie, Pfizer, Sun Pharma, UCB, Arcutis, and Lilly. James Q. Del Rosso has served as a consultant, investigator, and/or speaker for Ortho Dermatologics, Abbvie, Amgen, Arcutis, Dermavant, EPI Heath, Galderma, Incyte, LEO Pharma, Lilly, MC2 Therapeutics, Pfizer, Sun Pharma, and UCB. Robert T. Brodell has served as an investigator for Novartis and Corevitas; owns stock in Veradermics, Inc; serves on editorial boards of Practice Update Dermatology (Editor-in-Chief), Journal of the American Academy of Dermatology (Associate Editor), Practical Dermatology, Journal of the Mississippi State Medical Society, SKIN: The Journal of Cutaneous Medicine, and Archives of Dermatological Research; and has received educational grants from Pfizer. George Han is or has been an investigator, consultant/advisor, or speaker for AbbVie, Athenex, Boehringer Ingelheim, Bond Avillion, Bristol-Myers Squibb, Celgene, Eli Lilly, Novartis, Janssen, LEO Pharma, MC2, Ortho Dermatologics, PellePharm, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB.

Data availability statement

The data that support the findings of this study are available from the corresponding author, GH, upon reasonable request.

Additional information

Funding

The pharmacovigilance study was funded by Ortho Dermatologics. Medical writing support for this article was also funded by Ortho Dermatologics.