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.

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Acting Editor: Dr Catherine Brogan

Deputy Editor: Mr Michael Pittman

Contributor: Ms Jovi van der Kallen