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US updates CFTR modulator labels
The drug company Vertex has added a new safety warning to the prescribing information for its CFTR modulators. This update, published in March 2026, tells clinicians to watch for serious mental health symptoms in people taking these treatments. The Food and Drug Administration (FDA) in the United States update covers all CFTR modulators, including Kalydeco, Orkambi, Symkevi, Kaftrio (called Trikafta in the US), and Alyftrek.
In 2025, informed by feedback provided by the Trust, the MHRA, the UK medicines safety regulator a UK drug safety update was issued a safety update for the modulator Kaftrio, to warn about a higher risk of mental health related side effects. These included low mood, brain fog, sleep problems, and behaviour changes in children.
Modulator therapies have been transformational for many people with CF, and although most peoples’ experiences have been positive, this has not been the case for everyone. That’s why we have monitored feedback from the CF community closely and provided updates to the MHRA, the medicines safety regulator in the UK.
Dr Keith Brownlee, Director of Medical Affairs at Cystic Fibrosis Trust
Following these recent label changes in the US, we have contacted the MHRA to ask for a response. We’ll share more information when we have it.
You should always discuss with your CF team before changing or stopping any treatment or medications. You can also report any side affects you might be experiencing via the Yellow Card Scheme.
For more information you can call our Helpline on 0300 373 1000 or 020 3795 2184, Monday–Friday 10am–4pm, or email [email protected]
Contact your CF team if you have any questions about CFTR modulators, or if you, or your child experience any negative changes to mental or physical health while taking the treatment. They are there to help you and support you.
You should always speak to your CF team before you change, start, or stop any part of your treatment regimen.
If you have any issues, symptoms, or side effects with any medication or medical device, you can report it to the Yellow Card scheme. Click here to find out more.