Medicines Healthcare Products Regulatory Agency
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
- report suspected adverse drug reactions (ADRs) to the Yellow Card Scheme
Advice for healthcare professionals to give to patients and caregivers:
- fluoroquinolone antibiotics are a group of antibiotics that include ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin sometimes these medicines may also have a brand name so patients should check the details of all antibiotics prescribed to them
- if you are prescribed one of the antibiotics listed above and you suffer from depression or psychosis, tell your healthcare professional this is important as your symptoms may become worse under treatment
- psychiatric reactions include confusion, disorientation, anxiety, depression and suicidal thoughts or suicide attempts
- you may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking these medicines, and that they have rare psychiatric side effects associated with them others may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about
- if you develop thoughts of suicide or have attempted suicide, do not take any further doses of your fluoroquinolone, and talk to your doctor or another healthcare professional immediately
Reports of suicidal ideation and behaviour
The MHRA has received a Coroners 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 (SmPC) 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 (PIL) 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.
Report any suspected adverse drug reactions
Please continue to report any suspected adverse drug reactions to fluoroquinolones via the Yellow Card scheme. Your report will help us safeguard public health.
Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using:
- the Yellow Card website
- the Yellow Card app; download from the Apple App Store or Google Play Store
- some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)
When reporting, please provide as much information as possible, including information about batch numbers, medical history, any concomitant medication, onset timing, treatment dates, and product brand name.
Article citation: Drug Safety Update volume 17, issue 2: September 2023: 2.