MHRA Alert – Kaftrio: Psychological Side Effects in Cystic Fibrosis Treatment

Safety Update: Kaftrio Psychological Side Effects

The MHRA has issued a safety update regarding psychological side effects reported in patients with cystic fibrosis treated with Kaftrio. While these effects are infrequent, healthcare professionals should be aware of the risk profile and monitor patients accordingly.

Key Points

• Psychological side effects including anxiety, low mood, sleep disturbance, poor concentration, and forgetfulness have been infrequently reported
• These effects occur in patients with cystic fibrosis receiving Kaftrio therapy
• Healthcare professionals should remain alert to these potential adverse effects during treatment and follow-up
• Patient monitoring and discussion of mental health symptoms is recommended as part of routine care

Affected Medication

• Kaftrio (ivacaftor, tezacaftor, elexacaftor)

Recommended Actions

• Review patient monitoring protocols to include assessment of psychological symptoms
• Discuss potential psychological side effects with patients before and during treatment
• Report any suspected adverse effects to the MHRA via the Yellow Card scheme
• Refer to the full MHRA safety update for detailed guidance

For the complete safety alert and further information, visit the MHRA drug safety update page.