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MHRA Issues Safety Updates on Statins and Fluoroquinolones

A risk of psychiatric reactions with fluoroquinolones, recent reports of myasthenic gravis with statins, and a risk of death from entrapment or falls related to medical equipment have been highlighted in the latest monthly safety alert from the Medicines and Healthcare products Regulatory Agency (MHRA).

Statins are an "acceptably safe and effective" group of medicines, reassured the Medicines and Healthcare products Regulatory Agency (MHRA). However, although reports of worsening myasthenia gravis with medicines were "very rare", from 14 June 1995 up to 19 June 2023, the Agency said it had received 10 UK Yellow Card reports citing a statin as a suspect medicine for an adverse drug reaction involving myasthenia gravis.

A recent European review had prompted a recommendation for new warnings on the risk of new onset or aggravation of pre-existing myasthenia gravis with multiple statins. Marketing authorisation holders of atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin and pitavastatin containing products were instructed to amend the product information to say:

"In few cases, statins have been reported to induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia. [Product name] should be discontinued in case of aggravation of symptoms. Recurrences when the same or a different statin was (re-) administered have been reported."

The MHRA said that currently there was "insufficient data to conclude whether different statins, different duration of therapy and different dosing levels alter the risk of experiencing myasthenia gravis", and that it was "also unknown whether the development of new-onset myasthenia gravis following statin therapy is a transient or permanent condition".

Psychiatric Risk Reactions with Fluoroquinolones

As in its August roundup, fluoroquinolones came under the MHRA spotlight as the Agency reminded healthcare professionals to be alert to the associated risk of psychiatric reactions, including depression and psychotic reactions, which could potentially lead to thoughts of suicide or suicide attempts, and to advise patients to be alert to these risks.

A Coroner's report following the death of a patient — with had no previous history of depression or mental health problems — who had died by suicide after being treated with ciprofloxacin, raised concerns about the potential risk of suicidal behaviour in patients taking ciprofloxacin, the potential for increased risk in patients with depression, and the need to highlight this to healthcare professionals.

The MHRA pointed out that warnings on the potential for psychiatric adverse drug reactions — and the risk of suicidal ideation or suicide attempts — to occur with ciprofloxacin and other fluoroquinolones were already included in the product information leaflet, and within the summary of product characteristics, but the Agency said it was mindful of the importance of reminding relevant people of the potential risks.

It was not possible from available data to indicate a frequency, nor period of risk, for these potential adverse reactions, the MHRA explained.

Entrapment, Falls, and Deaths Related to Medical Equipment

Medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles were the subject of a National Patient Safety Alert following continued reports of deaths and serious injuries from entrapment or falls related to these pieces of equipment.

Over a period of 5 years, between January 2018 and December 2022, the MHRA said it had received 18 reports of deaths related to these devices and 54 reports of serious injuries – with the majority of these due to "entrapment or falls". 

Incidents involving falls often involved worn or broken parts, with those involving entrapment often related to inadequate risk assessments, a lack of maintenance and servicing, and children and adults with atypical anatomy using inappropriate equipment. Deaths were found to involve similar factors to those involved in entrapment, the MHRA highlighted.

The alert was issued to "support organisations" in updating their policies and procedures on procurement, provision, prescribing, servicing, and maintenance of these devices, in line with the Agency's updated guidance on the management and safe use of bed rails. 

It reminded organisations that their policies and procedures on procurement, provision, prescribing, servicing, and maintenance of these devices should be updated, and a plan developed for all applicable staff to have training relevant to their role within the next 12 months, with regular updates and all training recorded. 

In addition, other steps that must be taken included the implementation of maintenance and servicing schedules for devices and the prioritisation of devices which had not had regular maintenance and servicing. Also, wherever patients had been provided with bed rails or bed grab handles, a review should ensure there was a documented up-to-date risk assessment. 

The MHRA also stressed the importance of ensuring that the most up-to-date version of user instructions be provided to the bed occupant and/or their family and carers.

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