MHRA issues Drug Safety Update for Kaftrio
The MHRA’s Drug Safety Update notes there is a small increase in the risk of psychological side effects such as anxiety, low mood, sleep disturbance, poor concentration, and forgetfulness. It also notes that in some children, these side effects may show in changes to behaviour, such as being more disruptive.
The update highlights that changes usually occur within the first three months of starting Kaftrio, and that it can be difficult for people to know if their symptoms relate to Kaftrio or to something else. For some people, these changes can be associated with adjusting to the improvements that Kaftrio has on their physical health and their quality of life. For many, the symptoms may not last long, but others will continue to experience them whilst they take Kaftrio.
Kaftrio has helped transform the lives of many people with cystic fibrosis by treating the underlying cause of the condition. Although most people’s experiences have been positive, this has not been the case for everyone. The risk of side effects remains small, but if you have any concerns, you should speak to your CF team.
Dr Keith Brownlee, Medical Director at Cystic Fibrosis Trust
You can also report side effects via the Yellow Card Scheme, but always discuss with your team before changing or stopping any treatment or medications.
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 Kaftrio, or 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.