其 他 安 全 警 示
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| Singapore: Amoxicillin and risk of aseptic meningitis (English only) |
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Health Sciences Authority (HSA) advised healthcare professionals to consider the possibility of amoxicillin-associated aseptic meningitis in patients prescribed amoxicillin-containing products who present with aseptic meningitis after the exclusion of other infectious or disease-related causes. Amoxicillin-associated aseptic meningitis is a very rare but reversible adverse event (AE) that can be managed with drug discontinuation. As such, prompt recognition of this AE could prevent aggressive diagnostic procedures and prolonged treatments, as well as the possibility of recurrent episodes related to subsequent amoxicillin use.
Amoxicillin is a narrow-spectrum beta-lactam antibiotic registered in Singapore since 1998 for the treatment of commonly occurring bacterial infections such as respiratory tract, genitourinary and skin and soft tissue infections. It is available as a single ingredient or in combination with clavulanate, a beta-lactamase inhibitor.
Aseptic meningitis is a condition where the linings of the brain and spinal cord become inflamed without an infectious cause. Drugs such as non-steroidal anti-inflammatory drugs (NSAIDs), intravenous immunoglobulin and antimicrobials, including amoxicillin, have been identified as potential causes of aseptic meningitis. Other causes include neoplasia, autoimmune, or auto-inflammatory systemic diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis) and iatrogenic etiologies such as complications of a lumbar puncture or intrathecal drug adverse effects. The pathogenesis of drug-induced aseptic meningitis remains unclear but an idiosyncratic delayed-type hypersensitivity reaction has been proposed.
Very rare cases of aseptic meningitis associated with the use of amoxicillin-containing products have been published in literature. Patients typically presented with fever and headache which developed a few hours to seven days after amoxicillin exposure. Photophobia, nuchal rigidity, lethargy, myalgia and general malaise were also present in some cases. Notably, most cases demonstrated positive rechallenge, with two to three episodes of amoxicillin-induced aseptic meningitis. Typical cerebrospinal fluid (CSF) findings consisted of pleocytosis (lymphocytic or neutrophilic), which in some cases was accompanied by elevated protein and usually normal glucose levels (unlike low CSF glucose in bacterial meningitis). CSF cultures were consistently negative.
The diagnosis of amoxicillin-induced aseptic meningitis is usually based on a temporal relationship between drug intake and symptom onset, CSF pleocytosis, negative microbiological tests, and rapid resolution, usually within a few days, after drug discontinuation. As it is a diagnosis of exclusion, a thorough drug history can help support a diagnosis of amoxicillin-associated aseptic meningitis after infectious and disease-related (mainly neoplasms and autoimmune disorders) causes of aseptic meningitis have been ruled out.
In 2021, Health Canada reviewed the potential risk of aseptic meningitis in patients treated with amoxicillin-containing products and concluded that there might be a link between amoxicillin-containing products and the risk of aseptic meningitis. Their review took into consideration domestic and international cases of aseptic meningitis associated with amoxicillin use as well as a study of international cases reported to the World Health Organisation (WHO) database, which supported a link between the risk of aseptic meningitis and the use of amoxicillin.
To date, HSA has received one report of aseptic meningitis that was possibly associated with the use of amoxicillin/ clavulanic acid.
Currently, aseptic meningitis is a documented AE in the package inserts (PIs) of some amoxicillin-containing products. HSA is working with the product registrants of the remaining products to harmonise this safety information across the local PIs of all amoxicillin-containing products.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/amoxicillin-and-risk-of-aseptic-meningitis
In Hong Kong, there are 169 registered pharmaceutical products for human use containing amoxicillin and are prescription-only medicines. So far, the Department of Health (DH) has received 26 cases of adverse drug reaction related to amoxicillin, but these cases are not related to aseptic meningitis. Related news was previously issued by Health Canada and was posted on the Drug Office website on 11 Dec 2021. Letters to inform local healthcare professionals were issued on 13 Dec 2021. DH will keep vigilant on the further safety updates from the other overseas drug regulatory authorities.
Ends/Saturday, May 7, 2022
Issued at HKT 12:00
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