WHO: essential medicines list safety restrictions

The World Health Organization published its biannual update to the Model List of Essential Medicines, incorporating safety-driven restrictions on two antibiotics previously listed without qualification. Ciprofloxacin received a new annotation restricting its essential medicine status to infections where no alternative fluoroquinolone-sparing regimen exists, reflecting the accumulated evidence of disabling and potentially permanent musculoskeletal and neurological adverse effects.

What this means for practice: National formulary committees that align with the WHO Model List should review their fluoroquinolone prescribing guidelines. The WHO restriction carries significant influence in low- and middle-income countries where the Model List directly shapes procurement decisions.

FDA: cardiac safety complete response letter

The FDA issued a complete response letter for a novel antiarrhythmic agent in development for atrial fibrillation rate control, citing concerns from the mandatory thorough QT/QTc study. The study demonstrated a mean QTc prolongation of 18ms at the proposed therapeutic dose, exceeding the ICH E14 threshold of concern.

PRAC: pregnancy registry mandate

The PRAC recommended that the marketing authorization holder for a newly approved adalimumab biosimilar establish a mandatory pregnancy exposure registry as a condition of approval. The requirement reflects the committee's position that pregnancy safety data for biosimilars cannot be fully extrapolated from the reference product.