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.
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Medicines Safety Update - Information for health professionals
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