Difelikefalin

Is Difelikefalin safe?

Pooled trials: dizziness, diarrhoea, falls

The pooled trials reported several adverse events more often with difelikefalin than with placebo. The most frequent were diarrhea (9.0% versus 5.7% on placebo), dizziness (6.8% versus 3.8%), nausea (6.6% versus 4.5%) and gait disturbance including falls (6.6% versus 5.4%). Hyperkalemia, headache, somnolence and mental status change were also more common than on placebo. Somnolence was more common in patients 65 and older. The label warns about dizziness, sleepiness, mental status changes and gait problems. It also warns about added effects with other sedating drugs. Dizziness was the most common reason for stopping. ²

Less is known about long-term safety beyond the one-year open-label extensions. Less is known about safety in people with normal kidney function. The trial group was entirely on dialysis. ¹²

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