Clindamycin capsules and injections - acute kidney injury

A new warning about the nephrotoxic potential of clindamycin capsules and injections has been added to the Australian Product Information (PI). This is not a previously known adverse event associated with this medicine. Health professionals should consider monitoring renal function for certain patients.

Specific clindamycin products in Australia have been approved for the treatment of serious infections caused by susceptible strains of streptococci, pneumococci, staphylococci and anaerobic bacteria. Use should be reserved for penicillin-allergic patients or other patients for whom, in the judgement of the physician, a penicillin is inappropriate.

These clindamycin products are marketed under the brand names Dalacin C injections and Dalacin C capsules, as well as various generic brands. Please note that topical clindamycin products are not affected by this issue. More detailed information is available in the PI documents for Dalacin C injections and Dalacin C capsules.

This signal was first identified based on overseas adverse event data and the TGA has evaluated the issue.

The PI documents for Dalacin C injections and Dalacin C capsules have been updated to include the following information:

• Section 4.4 Special warnings and precautions for use
  Clindamycin is potentially nephrotoxic. Acute kidney injury including acute renal failure has been reported. Therefore, monitoring of renal function should be considered during therapy of patients with pre-existing renal dysfunction or taking concomitant nephrotoxic drugs and monitoring of renal function should be performed if therapy is prolonged.
• Section 4.8 Adverse effects
  Post-marketing experience - renal and urinary disorders: acute kidney injury (frequency not known).

This information will also be incorporated into the PI documents for generic brands.

Adverse event reports in Australia

Acute kidney injury has been reported in Australia. As of 17 November 2021, the Therapeutic Goods Administration (TGA) has received reports of 5 cases of renal impairment and 5 cases of acute kidney injury associated with systemic clindamycin. There have been no cases of acute renal failure reported in Australia. However, acute renal failure has been reported infrequently overseas.

Further reading

'Clindamycin-Induced Acute Kidney Injury: Large Biopsy Case Series' - Xie et al, Am. J Nephrology 2013;38:179-183

Disclaimer

Medicines Safety Update is aimed at health professionals. It is intended to provide practical information to health professionals on medicine safety, including emerging safety issues. The information in Medicines Safety Update is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Australian Government gives no warranty that the information in this document is accurate or complete, and shall not be liable for any loss whatsoever due to negligence or otherwise arising from the use of or reliance on this document.

© Commonwealth of Australia 2022

This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au.

For the latest safety information from the TGA, subscribe to the TGA Safety Information email list via the TGA website.

For correspondence or further information about Medicines Safety Update, contact the TGA's Pharmacovigilance and Special Access Branch at ADR.Reports@tga.gov.au.

Medicines Safety Update is written by staff from the Pharmacovigilance and Special Access Branch.

Acting Editor: Dr Catherine Brogan

Deputy Editor: Mr Michael Pittman

Contributor: Ms Jovi van der Kallen