The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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 - external site and Dalacin C capsules - external site.
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 - external site' - Xie et al, Am. J Nephrology 2013;38:179-183
What to report? You don't need to be certain, just suspicious!
The TGA encourages the reporting of all suspected adverse reactions to medicines, including vaccines, over-the-counter medicines, herbal, traditional or alternative remedies.
We particularly request reports of:
- all suspected reactions to new medicines (look for the Black Triangle in PI and CMI documents - this symbol identifies medicines that are new or being used differently)
- all suspected medicines interactions
- suspected reactions causing death, admission to hospital or prolongation of hospitalisation, increased investigations or treatment, or birth defects.
Reports may be submitted:
- online at www.tga.gov.au
- by fax to 02 6232 8392
- by email to ADR.Reports@tga.gov.au
For more information about reporting, visit www.tga.gov.au or contact the TGA's Pharmacovigilance and Special Access Branch ADR.Reports@tga.gov.au.
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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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