Alexander Mulroney

Ofloxacin is an antibiotic medicine within the class described as fluoroquinolones. It is known to be associated with or give rise to a variety of harms or risk of harms to the  patient, which are recognised by MHRA, which are catalogued as such in professional publications such as the British National Formulary and software applications in  widespread use by healthcare professionals providing on-screen alerts when  prescribing the drug, and which are stated within Patient Information Leaflets provided by manufacturers within the product packaging. The warnings refer to a wide range of possible harms, mainly of possible physical harm to tissue, or organs, or joints, or of  convulsions, or other injurious consequences, by and large in patients known to be  suffering from, or who have previously suffered from, defined pre-disposing conditions. They are broadly referred to as side effects. The warnings include reference to the risk of psychiatric harm, including suicidal thoughts, self-harming  behaviour and suicide. The warning includes the statement: “Fluoroquinolones can  cause psychiatric side-effects, including depression and psychosis, even after the first  dose. In rare cases, these can lead to thoughts or attempts of suicide, and have been  associated with the completed suicide of a patient without a history of psychiatric  disorders.” 

I heard evidence that these warnings within software applications are expressed as  either High Severity Warning (of which there is one) or Medium Severity Warnings (of  which there are 12). The high severity warning refers in non-specific terms to “very rare reports of disabling and potentially long-lasting or irreversible side effects” without mentioning suicide. The terms used would not ordinarily prompt consideration of death. The medium severity warnings begin with a reference to MHRA advising the  use of Ofloxacin with caution in psychiatric disorders – can exacerbate existing  symptoms which may lead to thoughts of suicide or suicide attempts. After the recital of many other warnings comprising some 41 lines of dense and small print text, all  relating to non-fatal outcomes, the 12th warning states, “Alert – MHRA advises  quinolones can cause psychiatric side effects including depression and psychosis  which can lead to thoughts or attempts of suicide.” 

I heard evidence that in a typical time constrained doctor/patient consultation, the  placing of an under stated 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 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. Ofloxacin is a dangerous product, notwithstanding its  benefits and widespread use. 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.