Published: 7 September 2023
Publications
Reports of persisting serious adverse reactions to fluoroquinolones
Published: 7 September 2023
Prescriber Update 44(3): 50–51
September 2023
The Centre for Adverse Reactions Monitoring (CARM) recently received
a case of ciprofloxacin-induced tendonitis in the shoulders (CARM ID
148295). This presented as severe pain in the shoulders radiating to
the wrist and hips starting within two weeks of taking ciprofloxacin.
The reactions persisted and had not resolved at the time of reporting.
The report coincides with the European Medicines Agency publishing a reminder for healthcare professionals to only prescribe fluoroquinolones (for oral use, inhalation or injection) according to their approved uses, due to the risk of disabling, long-lasting and potentially irreversible adverse reactions.1
Fluoroquinolones
The fluoroquinolones currently available in New Zealand include ciprofloxacin, moxifloxacin and norfloxacin. As with all medicines, fluoroquinolones should be used in the approved indications as listed in the data sheets and after careful assessment of the benefits and risks for the individual patient.
Prolonged, disabling and potentially irreversible serious adverse reactions
Fluoroquinolones have been associated with prolonged, disabling and potentially irreversible serious adverse reactions involving different and sometimes multiple body systems, such as the musculoskeletal and nervous systems.1–4
Some of these very rare but serious reactions are described below. Inform patients about the risks associated with fluoroquinolones and advise them to tell their doctor straight away if symptoms develop.1–4 Discontinuing fluoroquinolone treatment may reduce the risk of irreversible adverse reactions.1
Tendonitis and tendon rupture
Tendonitis (inflamed tendon) and tendon rupture (torn tendon) may occur at sites other than the ankle, as demonstrated by case described above. The Achilles tendon is most commonly affected, but any tendon can be involved.2–4
Time to onset has varied from within 48 hours after treatment initiation up to several months after discontinuation.1–3 The risk is increased in older patients, patients with renal impairment or solid organ transplants, and during concurrent treatment with corticosteroids.1–4
The first signs of tendonitis include painful swelling and inflammation.1–4
Peripheral neuropathy
Sensory or sensorimotor polyneuropathy (damage to nerves involved in sensation or sensation and movement) have been reported in patients receiving fluoroquinolones.1–4 Symptoms of peripheral neuropathy include pain, burning, tingling, numbness, or weakness.1–4
Other
Very rare cases of prolonged, disabling and potentially irreversible muscle pain or weakness, joint pain or swelling, fatigue, depression, problems with memory, sleeping, vision, hearing, and altered taste and smell have also been reported.1–4
New Zealand case reports of tendon disorders and neuropathy
CARM continues to receive reports of reactions relating to the tendon and neuropathy with fluoroquinolones. The number of reports is shown in Table 1.
Table 1: Number of reports of reactions relating to the tendon and neuropathy with fluoroquinolones received by the Centre for Adverse Reactions Monitoring, 1 January 2015 to 30 June 2023
| Reaction | Number of reports |
|---|---|
| Tendonitis | 43 |
| Tendon rupture | 15 |
| Tendon disorders | 7 |
| Paraesthesias and dysaesthesias | 12 |
| Peripheral neuropathy | 2 |
Notes:
- An individual report can have multiple reactions and may be represented in more than one of the reaction counts.
Source: Centre for Adverse Reactions Monitoring
References
- European Medicines Agency. 2023. Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects 12 May 2023. URL: www.ema.europa.eu/en/news/fluoroquinolone-antibiotics-reminder-measures-reduce-risk-long-lasting-disabling-potentially (accessed 28 July 2023).
- Viatris Ltd. 2022. Cipflox New Zealand Data Sheet 16 June 2022. URL: www.medsafe.govt.nz/profs/Datasheet/c/Cipfloxtabinf.pdf (accessed 26 July 2023).
- Bayer New Zealand Limited. Avelox New Zealand Data Sheet 1 October 2019. URL: www.medsafe.govt.nz/profs/Datasheet/a/AveloxtabIVinf.pdf (accessed 26 July 2023).
- Teva Pharma (New Zealand) Limited. Arrow – Norfloxacin New Zealand Data Sheet 9 November 2020. URL: www.medsafe.govt.nz/profs/Datasheet/a/ArrowNorfloxacintab.pdf (accessed 26 July 2023).
