其 他 安 全 警 示
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| Australia: Ceftriaxone and risk of hepatitis and encephalopathy (English only) |
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Therapeutic Goods Administration (TGA) announces that the Product Information (PI) for ceftriaxone has been updated to include a warning about encephalopathy, particularly in older patients with underlying renal impairment or central nervous system disorders. Hepatitis has also been listed as a potential adverse event of ceftriaxone, along with encephalopathy.
Ceftriaxone is a broad-spectrum cephalosporin antibiotic used in adults and children. Warnings about encephalopathy and hepatitis have been added to the ceftriaxone PI based on evidence published in the literature and from post-market adverse event data in Australia and internationally.
The following warning has been added to section 4.4 of the PI 'Encephalopathy has been reported with the use of ceftriaxone, particularly in elderly patients with severe renal impairment or central nervous system disorders. If ceftriaxone-associated encephalopathy is suspected (e.g. decreased level of consciousness, altered mental state, myoclonus, convulsions), discontinuation of ceftriaxone should be considered.'
'Hepatitis and hepatic cholestatic (frequency unknown)' and 'encephalopathy (rare)' have been added to section 4.8 of the PI as potential adverse effects.
To 16 Nov 2021, TGA has received 38 reports of hepatitis, 10 of cholestatic hepatitis, 3 of hepatomegaly and one of hepatocellular injury, all suspected to be related to ceftriaxone. TGA has also received 3 reports of encephalopathy for ceftriaxone. Two of these cases are described in a study reviewing case reports of patients with cephalosporin-related neurotoxicity in Western Australia.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/publication-issue/ceftriaxone-and-risk-hepatitis-and-encephalopathy
In Hong Kong, there are 33 registered pharmaceutical products containing ceftriaxone. All products are prescription-only medicines. So far, the Department of Health (DH) has received 6 cases of adverse drug reaction related to ceftriaxone, of which one case was related to coma and cerebral edema. Related news on the potential risk of encephalopathy in patients treated with ceftriaxone-containing products was previously issued by Health Canada, and was posted on the Drug Office website on 4 Feb 2021. The risks of hepatitis and adverse neurologic events (including encephalopathy) associated with the use of ceftriaxone are documented in overseas reputable drug references such as the “AHFS Drug Information”. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, Dec 15, 2021
Issued at HKT 15:00
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