MHRA Drug Safety Update
September 2023
Globally, there has been a very small number of reports of new-onset or aggravation of pre-existing myasthenia gravis with atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin and pitavastatin (single-ingredient and fixed-dose combination products). Advise patients taking statins to be alert to new symptoms for myasthenia gravis, or worsening symptoms of pre-existing myasthenia gravis, and to seek medical advice if these occur.
Healthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of psychiatric reactions, including depression and psychotic reactions, which may potentially lead to thoughts of suicide or suicide attempts. Healthcare professionals are also reminded to advise patients to be alert to these risks.
A summary of recent letters and notifications sent to healthcare professionals about medicines, and a recent National Patient Safety Alert highlighting the risk of deaths and serious injuries from entrapment or falls relating to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles.
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Drug Safety Update is a monthly newsletter from the Medicines and Healthcare products Regulatory Agency (MHRA) and its independent advisor the Commission on Human Medicines.
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