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A life-changing cystic fibrosis medication is claimed to be causing anxiety, depression and even suicidal thoughts in some patients.

Wonder-drug Kaftrio was made available to cystic fibrosis (CF) patients in the UK in June 2020 and has been hailed as the closest thing to a ‘cure’ we currently have for people with CF.

It is expected to prolong the lives of people with CF and has seen some patients’ lung functions improve by up to 40%.

Cystic fibrosis is a life-shortening, doxycycline omega 3 chronic illness caused by a defective gene, affecting 10,500 people in the UK.

It causes passageways in the lungs and digestive system to become blocked with sticky mucus, eventually resulting in fatal lung damage and several other health problems. 

After a four-year battle, in November 2019, the UK gained access to Orkambi and sister drugs Symkevi and Kalydeco. It was a huge success for the CF community.

At the time, access to these medications, which carried the unaffordable price tag of £100,000 per patient per year, still didn’t seem very hopeful, and the disheartening battle to get Vertex to lower its price saw many lose hope.

But just eight months later, the NHS signed a commercial agreement with Vertex Pharmaceuticals to make Kaftrio, an even more powerful drug, available to those aged 12 and over with cystic fibrosis. This was extended to those aged six years and above in early 2022.

Unlike my other medications, which treat the symptoms of CF, Kaftrio treats the underlying causes for 90% of people with CF.

It directly targets the cause of CF by restoring the function of the CFTR protein towards normal for those with the most common CF gene abnormality (DF508). 

Nicola Torch, a full-time PhD student living in Scotland, ‘started crying’ when she saw the announcement that Kaftrio was finally available on the NHS.

‘I looked at my mum, and I just started sobbing,’ the 26-year-old tells Metro.co.uk.

‘Throughout my life, I had never dared to think about the future. I’d never thought about a long-term career, getting married, having kids or any of those exciting life goals younger people envision. 

‘Kaftrio allowed me to start picturing those things, and I was excited about my future for the very first time.’

Nicola started taking Kaftrio in October 2020 and felt physical changes almost immediately.

‘It was a momentous occasion.’ she says.

The day after taking Kaftrio, Nicola woke up feeling ‘like a new person’.

‘Breathing was just so easy. It didn’t feel like something heavy was sitting on my chest for once. 

‘My breathlessness also seemed to disappear. I did my lung function after a few days and was shocked to see numbers I hadn’t reached since my teens. 

‘That weekend, I went out walking. I reached a hill that, before Kaftrio, I would always struggle to climb. But this time, I shot up and didn’t feel an ounce of breathlessness at the top.

‘It was overwhelming, and I immediately got teary-eyed. It felt like confirmation that the medication was working as I hoped it would.’

For Nicola, the impact that Kaftrio had on her mental health was not something she was initially aware of. It wasn’t until the start of 2022 that she noticed she was no longer feeling herself and was experiencing crippling anxiety.

During a long weekend away at the start of this year, Nicola realised she had left her Kaftrio tablets home.

‘I was without it for four days, and the difference I felt was too hard to ignore,’ she says.

‘This medication was improving my physical health so much, and it felt wrong to question whether it was also impacting me negatively.’

In early May, Nicola made the difficult decision to come off Kaftrio and almost immediately noticed changes to her mental health.

‘I felt lighter, clearer and more level-headed,’ she says.

‘Coming off Kaftrio was definitely the best decision for my mental health. 

‘I was so miserable that I didn’t care that my lungs were feeling better. This created a lot of guilt and inner conflict.’

‘A month off Kaftrio, and I’m back to my old self. Admittedly my physical health has suffered as a result – my cough and breathlessness are back, and my lung function has dropped to pre-Kaftrio levels.

‘But I’m trying not to see it as a backwards step, just a sideways one.’

Nicola has noticed the backlash experienced by those who have spoken out about the mental health impacts of Kaftrio.

‘The CF community became very divided, and people seemed to get very territorial about the drug,’ she explains.

‘Kaftrio is still an incredible treatment that the CF community is lucky to have, and I am in no way trying to downplay the life-changing potential it has.

‘However, being transparent about the full spectrum of experiences is also important.’

Elaina Mowle, a special projects administrator at a care company, also experienced immense physical benefits – and severe mental health impacts – after starting Kaftrio.

‘I noticed the impact of the drug on my lungs so quickly,’ she says. ‘Within a few hours, I could feel lots of mucus coming up. It was wild.

‘In terms of wheeze, tightness, and lung pain, Kaftrio definitely helps.’

But things soon took a turn for the worse for the 22-year-old from Eastbourne.

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Elaina began feeling exhausted and disconnected. The increased weight gain, a common side effect of the medication, started to impact her mental health, and despite the positive changes to her lungs, ‘the weight gain, poor body image and lack of any sleep made me feel awful’.

‘I was so miserable that I didn’t care that my lungs were feeling better,’ Elaina says. ‘This created a lot of guilt & inner conflict.’

In November 2020, Elaina stopped taking Kaftrio altogether, but in April 2022, she decided to have another go.

This, she says, was when things began to get worse.

‘I started to have low moods, depressive episodes and even suicidal thoughts,’ Elaine tells Metro.co.uk.

‘It was terrifying. So on the off chance, it was the Kaftrio causing these feelings, I stopped it. 

‘And less than 24 hours later already started to feel miles better. It put into perspective how much of an impact the Kaftrio had had on me psychologically.’

Now Elaina takes Kaftrio twice a week in an attempt to balance the positive impact on her lungs with what she sees as detrimental mental side effects.

‘I am so happy that Kaftrio is working wonders for so many people,’ she explains. ‘I just want people to be aware that side effects are a massive factor to consider when taking any drug.’

‘One person’s wonder drug may be another’s nightmare.’

It was terrifying

Dr Keith Brownlee, Director of Medical Affairs at the Cystic Fibrosis Trust, tells Metro.co.uk that Kaftrio is not a cure, and it doesn’t work for everyone. 

‘Mental health issues were not reported in the clinical trials that led to the market authorisation of Kaftrio,’ he explains.

‘However, there have been reports of individuals associating new or worsening mental health issues with starting Kaftrio.

‘In addition, the life-changing effects of Kaftrio can themselves have mental health consequences. 

‘These are complex issues which need to be investigated thoroughly. We strongly advise all people with CF who feel they may have mental health symptoms as a side effect of Kaftrio to report their concern using the yellow card system of the MHRA (Medicines and Healthcare products Regulatory Agency) and speak to their CF team.’

The roll-out of Kaftrio took some time and Lucy Taylor didn’t start taking Kaftrio until March 2021. 

The 29-year-old play centre assistant from South Wales was nervous to start taking the drug, feeling apprehensive that it wouldn’t have the life-changing effects she had seen others experience.

‘But thankfully, it started doing its magic pretty much instantly,’ she says.

‘I started feeling the effects and changes of Kaftrio no more than 15 minutes after I swallowed the first dose.

‘My lung function had shot up 7% in a matter of days. It was such an incredible feeling.

‘After a couple of months, my lungs felt so good. I could take a deep breath in without coughing. I didn’t feel so tired all of the time. Exercising felt much easier, and I could keep up with my family and friends.’

Seven months later, in November 2021, Lucy started to notice changes in her mental health.

‘I was really low and started to shut myself off from the rest of the world,’ she tells us.

‘I realised that Kaftrio was making my mental health worse after chatting to others with CF, who were also taking the drug and experiencing the same impacts.’

Lucy kept up the pretence to family and friends but eventually broke down to her mum on Christmas Eve. She thought telling her loved ones about her experience would help, but soon after, things reached a point where Lucy no longer wanted to get up in the morning.

‘I started to shut myself off from the rest of the world

Rather than coming off Kaftrio, Lucy has been speaking to a psychologist.

‘I wanted to continue to stay on Kaftrio,’ she says.

‘I couldn’t let this bad spell on my mental health beat me. Kaftrio has had a hugely beneficial impact on my physical health. 

‘I am still incredibly grateful that I am on Kaftrio. I know that it has negatively impacted my mental health, and that was such a scary time. But every drug has side effects.

‘For me, Kaftrio truly is a wonder drug, and the positives certainly outweigh the benefits.’

Drug manufacturer Vertex told Metro.co.uk: ‘We review all reported adverse events from the use of our medicines. They are evaluated and submitted to the regulatory authorities in accordance with all applicable regulations. 

‘A relationship between the use of our medicines and mental health-related adverse events has not been established in either clinical trial data or post-licensing reports. 

‘The safety and efficacy profile of Kaftrio® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor has been demonstrated in more than 40,000 patient-years of data globally.’

The drug watchdog told Metro.co.uk that ‘there is no confirmed evidence of an association with Kaftrio and mental health-related or psychiatric side effects.’

‘Patient safety is our first priority. Kaftrio is an effective medicine for people suffering from cystic fibrosis,’ Dr Alison Cave, MHRA Chief Safety Officer, told Metro.co.uk.

‘As with all approved medicines, we continually monitor the safety of Kaftrio. There is no confirmed evidence of an association with Kaftrio and mental health-related or psychiatric side effects. The balance of benefits and risks of Kaftrio remains favourable for the treatment of cystic fibrosis.

‘It is important you continue to take your medication. If you have any questions, speak to your Cystic Fibrosis Team or healthcare professional. Please report any suspected side effects to our Yellow Card scheme.’

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