The MHRA will consider whether further action is needed after a coroner warned doctors were unaware of a rare risk of suicide linked to the commonly used antibiotic ciprofloxacin.
A prevention of future deaths report said that a respected and experienced consultant cardiologist, who had recently retired, died by suicide 11 days after being prescribed a course of ciprofloxacin to relieve his symptoms of prostatitis ahead of investigations for prostate cancer.
The inquest into his death heard that Dr Robert Stevenson, who had worked at Huddersfield Royal Infirmary, had no previous history of depression or mental health problems.
On the day he died, he had left the house for his usual walk and his family had no indications that suggested they should be concerned, coroner Martin Fleming said. The 63-year-old messaged his wife to say that he had left a note under his pillow and was later found dead in a nearby wood.
In a report sent to medicines regulators, Mr Fleming said the urologist who had prescribed the antibiotic had referred him to published literature linking ciprofloxacin and quinoline antibiotics with a potential rare link to suicidal behaviour.
While it was unclear if he was suffering from this side effect, it remained possible, he said.
‘I heard evidence to suggest that the prescribing doctor did not reference this side effect at the time of issuing the prescription to Mr Stevenson, since it was not in accord with current advice,’ Mr Fleming wrote.
‘I also heard evidence to suggest that prescribing doctors may not be fully aware of this rare side effect, and that patient’s suffering from depression may be more vulnerable to it.’
In the report sent to the Medicines and Healthcare products Regulatory Agency (MHRA) he continued: ‘I am therefore concerned that this potential risk has not been given sufficient emphasis and I would ask you to consider the appropriateness of reviewing the current guidelines as to the dispensation of the drug to patients by clinicians and increasing the awareness of the side effect in order to monitor and mitigate the risks.’
Psychiatric side effects, including suicidal behaviours, have been reported following ciprofloxacin and the patient information leaflet warns of these risks, the MHRA said.
In response to the coroner’s report, Dr Janine Jolly, MHRA deputy director of benefit/risk Evaluation, said: ‘We are very sorry to hear of Dr Stevenson’s death and would like to express our sympathies to his family.
‘As with any serious suspected side effects, reports of fatalities are evaluated by us including an assessment of post-mortem details if available. We will be reviewing the coroner’s verdict.
‘We will carefully consider the points raised by the coroner in the Regulation 28 Report to consider whether further regulatory action is required to minimise risks to patients and will provide a response upon completion of our investigation.’