Other safety alerts
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| Australia: Clindamycin capsules and injections: Acute kidney injury |
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The Therapeutic Goods Administration (TGA) announces that 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.
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.
Acute kidney injury has been reported in Australia. As of 17 Nov 2021, the 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/clindamycin-capsules-and-injections-acute-kidney-injury
In Hong Kong, there are registered pharmaceutical products containing clindamycin which are oral capsules (2 products) and injectables (3 products). All products are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to systemic use of clindamycin, but this case was not related to kidney injury. In light of the above TGA’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Feb 4, 2022
Issued at HKT 16:00
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