The Medicines and Healthcare products Regulatory Agency (MHRA) will review its regulatory and risk-minimisation measures around fluoroquinolone antibiotics following a patient’s death.
A prevention of future deaths report, published October 30, determined that “on the balance of probability”, ofloxacin prescribed to Alexander Mulroney “did not cause death but induced a determination to end his life”.
The coroner behind the report said Mulroney died on December 18, 2025, and the cause of death was suicide.
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Mulroney was prescribed ofloxacin, a fluoroquinolone antibiotic, after a first-line treatment failed to clear a recurrence of a previous condition that caused urinary and genital symptoms, and began taking the medicine as prescribed from December 16, 2025.
The coroner said Mulroney was “an intelligent and successful lawyer with a wife and children he loved” and “had no history of emotional or mental ill-health” prior to his death.
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The report noted that patient information leaflets (PILs) for fluoroquinolones include warnings which reference “the risk of psychiatric harm, including suicidal thoughts, self-harming behaviour and suicide” even after the first dose.
And it said such warnings also feature in on-screen alerts to healthcare professionals when prescribing the drug.
“Missed, misleading or ineffective”
But the coroner said he heard evidence that only after “many other warnings comprising some 41 lines of dense and small print text, all relating to non-fatal outcomes”, comes the MHRA’s warning that fluoroquinolones can cause psychiatric side effects that can lead to suicide attempts.
He said 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”.
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“The current approach to publishing warnings of possible harm provides insufficient safeguards and fails properly and adequately to inform both prescribers and patients of danger,” he added.
The coroner stressed that ofloxacin “is a dangerous product” and that the “current approach to publishing warnings of possible harm provides insufficient safeguards, and fails properly and adequately to inform both prescribers and patients of danger”.
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The MHRA responded on September 21 that both the current ofloxacin PIL and summary of product characteristics contain warnings that patients may experience psychiatric reactions which, in rare cases, can lead to suicide attempts, even when taking it for the first time.
But it noted the concerns raised regarding “both the risk of serious psychiatric adverse reactions” relating to these medicines and the “effectiveness of current risk communications”, and said it will “consider this matter further” through a safety review.
The regulator said the review will assess “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”.
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And it added that it will update the coroner of the review’s findings accordingly.
It comes after the MHRA updated patient safety information for antidepressants last month to “improve the prominence and clarity” of warnings about suicidal thoughts and behaviour and sexual dysfunction.
And it follows a GP surgery implementing two new policies on prescribing in September following the death of a patient with a “documented history of prescription medication misuse and overdose”.
