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Recent epidemiological evidence suggests a possible small increased risk of congenital cardiac defects in association with fluoxetine in early pregnancy, similar to that seen with paroxetine. There are insufficient data to draw conclusions on whether there is a similar risk...
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after treatment has stopped. Healthcare professionals are...
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...
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals...
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
Systemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate. This follows a review by the MHRA which looked at the effectiveness of current measures to reduce the identified risk of disabling and potentially long-lasting or...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the medicine piflufolastat (18F) (Pylclari) as a diagnostic tool for people with suspected or known prostate cancer.
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