Charles Rendell
11 Jan 2017 · Coroner Peter Bedford · Berkshire
The coroner's concerns
1. suicidal ideation from ciprofloxacin
“During the course of the Inquest, I referred to a letter I had received from , Acting Head of Pharmacovigilance at your company dated 28 November 2016. I was also referred to a variety of published literature relating to Ciprofloxacin and Quinolone Antibiotics and a potential link to suicide behaviour in patients.”
2. inadequate warning about suicidal risk
“Ciprofloxacin carries warnings/precautions that, in rare cases, depression or psychosis can progress to suicidal ideations/thoughts culminating in attempted suicide or completed suicide. However, it is unclear how clearly this is made known to Ciprofloxacin users.”
3. lack of clinician awareness of early onset risk
“The literature suggests that this type of side effect can occur even soon after commencing Ciprofloxacin at a comparatively low dose. As it is an antibiotic, there is no compelling reason why patients should expect to have this effect unless this fact, and potential symptoms, are brought clearly to their attention by prescribing clinicians.”
4. clinicians not alerting patients to risk
“One of Mr [name redacted] family members is a general practitioner in New Zealand. At the Inquest, she advised that she had no knowledge of the potential effect of Ciprofloxacin and, in conversation with her colleagues, nor did they. I am therefore concerned that this potential risk has not been given sufficient emphasis and that consideration should be given to prescribing clinicians highlighting the symptoms and suggesting to patients that they are alert of the possibility and react appropriately.”