The product information for ceftriaxone has recently been updated to include warnings regarding encephalopathy and hepatitis.

Encephalopathy is a rare adverse effect associated with third- and fourth-generation cephalosporins. Symptoms may include a decreased level of consciousness, altered mental state, myoclonus, and convulsions. One review noted that baseline renal insufficiency was present in 72% of cases of cephalosporin-associated encephalopathy. Advanced age and a history of central nervous system disease are also risk factors. As of 15 December 2021, the  Therapeutic Goods Administration (TGA) has received three reports of encephalopathy related to ceftriaxone. The TGA advises that cessation of the antibiotic should be considered if ceftriaxone-associated encephalopathy is suspected.

Drug-induced liver injury is a significant cause of liver failure. With the exception of paracetamol, studies have found antibiotics to be the most frequent medication group implicated in this condition. As of 15 December 2021, the TGA has received 38 reports of hepatitis, ten of cholestatic hepatitis, three of hepatomegaly, and one of hepatocellular injury suspected to be related to ceftriaxone.

The TGA urges healthcare professionals to be aware of these adverse events as they can be serious. Further information can be found in the product information.

References:

  1. Bhattacharyya S, Darby RR, Raibagkar P, Gonzalez Castro LN, Berkowitz AL. Antibiotic-associated encephalopathy. Neurology. 2016; 86(10): 963-71.
  2. Nash E, Sabih AH, Chetwood J, Wood G, Pandya K, Yip T, et al. Drug‐induced liver injury in Australia, 2009–2020: the increasing proportion of non‐paracetamol cases linked with herbal and dietary supplements. Med J Aust. 2021; 215 (6): 261-268.
  3. Therapeutic Goods Administration. Ceftriaxone and risk of hepatitis and encephalopathy. Woden: TGA; 2021.
  4. Therapeutic Goods Administration. Database of Adverse Event Notifications – medicines. Woden: TGA; 2021.

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