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The Medicines and Healthcare products Regulatory Agency (MHRA) has said it will review whether the risks of psychiatric side effects in fluoroquinolone antibiotics are effectively communicated, following the death of a patient.
In a ‘Prevention of future deaths’ report, published on 30 October 2026, Ian Wade, assistant coroner for Berkshire, described how Alexander Mulroney, who took his own life in a fatal car accident on 17 December 2025, had begun taking prescribed ofloxacin the day before his death, after a previously prescribed first-line antibiotic had been ineffective.
“On the balance of probability, the prescribed ofloxacin did not cause death but induced a determination to end his life,” the coroner wrote.
The coroner noted that fluoroquinolone patient information leaflets warn that the drugs can cause psychiatric side effects, including depression and psychosis, even after the first dose.
He also said that he had heard evidence that software applications used by healthcare professionals may not flag these warnings with high enough visibility.
“I heard evidence that in a typical time constrained doctor/patient consultation, the placing of an understated reference to the possibility of suicidal thoughts at the end of a relatively long and complex list of so-called medium severity alerts is missed, or is misleading, or is ineffective,” the coroner continued.
“The death by suicide of Alexander Mulroney, a patient with no previous history of emotional or mental ill-health, nor a person considered to be at risk of self-harm, soon after commencing a course of a fluoroquinolone is not the first such fatal outcome linked to such medication.”
In response to the coroner’s report, sent on 21 September 2026, the MHRA noted that the current patient information leaflet for ofloxacin advises patients that they may experience psychiatric reactions when taking ofloxacin — including when taking it for the first time — and that, rarely, depression or psychosis can progress to thoughts of suicide or suicide attempts.
The summary of product characteristics for ofloxacin carries a similar warning, it added.
However, the MHRA said: “We note the concerns raised regarding both the risk of serious psychiatric adverse reactions associated with fluoroquinolones, including ofloxacin, and the effectiveness of current risk communications.
“We will therefore consider this matter further through the MHRA’s medicines safety review processes.
“As part of this review, we will consider whether the current regulatory and risk-minimisation measures remain appropriate and whether any further action is required to support the safe use of these medicines.”
The MHRA also highlighted that it would update the coroner with its findings following the safety review.
In its own response to the coroner’s report, sent on 14 September 2026, the BNF said that information to support the safe and effective prescribing of drugs was part of BNF content.
Third-party system developers can use this information to create a hierarchy of warnings, but the hierarchy is not determined by the BNF, it added.
The BNF said that they understand the concerns around whether the current communication approach adequately informs prescribers and patients of danger.
“We work closely with the MHRA on drug safety issues. We will reach out to the MHRA to discuss ways of further highlighting the warnings around the use of ofloxacin and the quinolones drug class to prescribers and patients,” it wrote.
