The NPRA has updated information about this safety issue. See the NPRA Safety Alerts published on 7 August 2023.

Overview

Clindamycin is a lincosamide antibiotic indicated for the treatment of various infections caused by susceptible anaerobic bacteria, susceptible strains of gram-positive aerobic bacteria such as streptococci, staphylococci and pneumococci, and susceptible strains of Chlamydia trachomatis.¹ In Malaysia, there are currently nine (9) registered products containing clindamycin (excluding topical preparations).²

Background of Safety Issue

The National Pharmaceutical Regulatory Agency (NPRA) received information from the European Medicines Agency (EMA) on the risk of acute renal failure associated with the systemic use of clindamycin.³

Following the review on data from the European pharmacovigilance database (EudraVigilance), published literature, and data submitted by the product registration holder, EMA concluded that there is a potential link between clindamycin-containing medicinal products for systemic use and the risk of acute renal failure.³ It is suggested that clindamycin-induced renal injury may be linked to the precipitation of high urine concentrations of clindamycin in the renal tubule that may cause tubular obstruction and thus result in direct tubular toxicity.^4,5

Adverse Drug Reaction (ADR) Reports⁶

To date, the NPRA had received a total of 245 reports with 398 adverse events suspected to be related to clindamycin-containing products for systemic use. Of these reports, two (2) reported events of acute kidney injury.

Advice for Healthcare Professionals

• Be aware of the potential risk of acute kidney injury when prescribing clindamycin.
• Educate patients on the sign and symptoms of acute kidney injury such as decreased urine output, angioedema, dyspnoea, or nausea.
• Consider monitoring of renal function in patients receiving prolonged therapy, suffering from pre-existing renal dysfunction or taking concomitant nephrotoxic drugs.
• Please report all suspected adverse events associated with clindamycin to the NPRA.

References:

1. National Pharmaceutical Regulatory Agency (NPRA). The Malaysian Product Registration Database (QUEST). DALACIN C CAPSULE (clindamycin) package insert [Internet]. 2018 Aug 27 [cited 2021Oct 28]. Available from: http://www.npra.gov.my (access restricted).
2. National Pharmaceutical Regulatory Agency (NPRA). QUEST3+ Product Search [Internet]. 2021 [cited 2021 Oct 28] Available from: https://www.npra.gov.my
3. Pharmacovigilance Risk Assessment Committee (PRAC). PRAC recommendations on signals Adopted at the 3-6 May 2021 PRAC meeting: European Medicines Agency (EMA) [Internet]. 31 May 2021 [Cited 2021 June 10]. Available from: https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-3-6-may-2021-prac-meeting_en.pdf
4. Sarwal A, Chiu C-Y, Feinstein A. Does Clindamycin Induce Acute Kidney Injury? Am J Med Sci [Internet]. 2020;359(5):303. Available from: https://doi.org/10.1016/j.amjms.2020.02.005
5. Xie H, Chen H, Hu Y, Xu S, He Q, Liu J, et al. Clindamycin-Induced Acute Kidney Injury: Large Biopsy Case Series. Am J Nephrol [Internet]. 2013;38(3):179–83. Available from: https://www.karger.com/DOI/10.1159/000354088
6. National Pharmaceutical Regulatory Agency (NPRA). The Malaysian National ADR Database (QUEST) [Internet]. 2021 [cited 2021 July 15]. Available from: https://www.npra.gov.my (access restricted).

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.