Other safety alerts
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| The United Kingdom: Fluoroquinolone antibiotics: suicidal thoughts and behaviour |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of psychiatric reactions, including depression and psychotic reactions, which may potentially lead to thoughts of suicide or suicide attempts. Healthcare professionals are also reminded to advise patients to be alert to these risks.
The MHRA has received a Coroner’s report following the death of a patient who died by suicide after being treated with ciprofloxacin. The patient had no previous history of depression or mental health problems. The Coroner raised concerns about the potential risk of suicidal behaviour in patients taking ciprofloxacin, the potential for increased risk in patients with depression, and the need to highlight this to healthcare professionals.
Warnings on the potential for psychiatric adverse drug reactions to occur with ciprofloxacin and other fluoroquinolones are included in the product information. The Summary of Product Characteristics states that psychiatric reactions may occur with ciprofloxacin, including after the first dose. In rare cases, depression or psychosis can progress to suicidal ideation or suicide attempts. If this happens, ciprofloxacin should be discontinued immediately. The Patient Information Leaflet advises patients that they may experience psychiatric reactions. If patients suffer from depression or psychosis before being prescribed this medication, their symptoms may become worse under treatment with ciprofloxacin. In rare cases, depression or psychosis can progress to thoughts of suicide or suicide attempts. If this happens, patients are advised to contact their doctor immediately.
It is not possible from available data to indicate a frequency nor period of risk for these potential adverse reactions. Patients should be advised to seek medical attention for any psychiatric symptoms, even if it has been some time since they stopped taking the medication.
Advice for healthcare professionals:
- Advise patients to carefully read the advice in the Patient Information Leaflet about possible psychiatric reactions, and to seek medical advice if they experience these symptoms.
- When prescribing a fluoroquinolone, advise patients to be alert to any mood changes, distressing thoughts, or feelings about suicide or harming themselves at any point during treatment.
- Note that fluoroquinolones can exacerbate existing psychiatric symptoms.
- Advise patients to seek medical advice if they develop such thoughts or behaviours, and ensure that a suitable referral for treatment is made, if necessary.
- Fluoroquinolones should be discontinued at the first signs of a serious adverse reaction, including new or worsening depression or psychosis.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-suicidal-thoughts-and-behaviour
In Hong Kong, there are registered pharmaceutical products containing systemic fluoroquinolones for use in human, including ciprofloxacin (51 products), levofloxacin (45 products), moxifloxacin (6 products), norfloxacin (3 products), ofloxacin (15 products) and prulifloxacin (one product). All products are prescription-only medicines. There is no registered pharmaceutical product containing delafloxacin.
So far, the Department of Health (DH) has received 4 cases of adverse drug reaction related to ofloxacin, all of these cases were related to attempted suicide/completed suicide. The DH has received adverse drug reaction related to ciprofloxacin (one case), levofloxacin (13 cases) and moxifloxacin (one case), but these cases were not related to depression, psychotic reactions, suicidal ideation or suicide. The DH has not received any case of adverse drug reaction related to norfloxacin and prulifloxacin.
The risk of depression, psychotic reactions, suicidal ideation and suicide associated with the use of fluoroquinolones is documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. The DH will remain vigilant on safety update of the drugs issued by other overseas drug regulatory authorities.
Ends/Wednesday, Sep 27, 2023
Issued at HKT 16:00
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