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Prescribers must be told about link of suicide risk to ciprofloxacin

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Prescribers must be told about link of suicide risk to ciprofloxacin

By Neil Trainis

The Medicines and Healthcare products Regulatory Agency has said it will review a coroner’s recommendation that the risk of suicide as a potential side-effect of taking the antibiotic ciprofloxacin should be made clear to prescribers.

The warning from the senior coroner for West Yorkshire Martin Fleming followed an inquest into the suicide of Dr Robert Stevenson, 63, who took his own life after being prescribed ciprofloxacin, according to the BBC.

Dr Stevenson, a retired doctor who worked at Huddersfield Royal Infirmary, was prescribed ciprofloxacin to relieve his pain having been referred for suspected prostate cancer.

According to the coroner’s report, he had no history of depression or mental health problems but was found dead 11 days later having gone for a walk. The inquest heard Dr Stevenson left a note under his pillow for his wife which consisted of “uncharacteristically confused and illogical” anxieties.

It also heard he had not been warned by his prescriber about a “potential rare link to suicide behaviour” in patients who take a class of antibiotics called quinolone antibiotics. In his report, Fleming said it was not certain that Dr Stevenson had experienced that side-effect as a result of taking the antibiotic but maintained it was possible.

During the inquest, it was established that prescribers are not required to inform patients about that risk. Fleming contacted the MHRA to ask it to review its guidelines for ciprofloxacin having told the regulator he was “concerned that this potential risk has not been given sufficient emphasis.”

“I also heard evidence to suggest that prescribing doctors may not be fully aware of this rare side-effect and that patients suffering from depression may be more vulnerable to it,” he said.

The MHRA's deputy director of benefit/risk evaluation Dr Janine Jolly said it will “consider whether further regulatory action is required to minimise risks to patients and will provide a response upon completion of our investigation.”

Dr Jolly said reports of “psychiatric side-effects, including suicidal behaviours” had been received even though the drug’s patient information leaflet warns of those risks.

“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,” she said.

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