Category: Uncategorised

Published Monday 22th July 2024, updated Friday 26th July 2024

On Sunday 21^st July we were made aware that a large batch of Flolan 1.5mg, currently with patients around the UK, is being recalled and replaced as a precaution due to damage it may have sustained during the packing process.

Flolan (a type of epoprostenol) is taken by approximately 200 adults and children in the UK, as a continuous infusion via a line into the chest.

The drug, manufactured by GlaxoSmithKline (GSK), is supplied in glass vials - and hairline cracks may have been sustained in 60% of the current stock in the UK when it was being packed by a third-party supplier. This damage is not visible to the naked eye, but there is a chance it could affect how sterile the drug is.

Therefore, it is important that all patients taking this drug exercise strict infection control measures as usual and remain vigilant for signs of infection. If you suspect anything is wrong, please contact your specialist team immediately.

IMPORTANT: A medical assessment of the risk / benefit ratio has been carried out and the advice from PH specialists, the drug manufacturers, and the PHA UK is to continue to take the medication you currently have. It is far safer to do this than to pause it until new stock is delivered to you.

Please note, this issue affects only Flolan 1.5mg, and not other brands of epoprostenol.

All patients identified as having received affected stock have been contacted and arrangements made for replacement medication delivery.

It has been confirmed that there is enough stock in the UK to cover all the replacements needed.

Please be reassured that the safest thing to do is to continue to take the medication you have been prescribed.

If you have concerns about your physical wellbeing, as always, please contact your specialist team as soon as possible. If you have been affected by this issue, you will be contacted by your homecare delivery provider imminently with regards to replacing the stock.

On behalf of patients impacted by this situation, we asked GSK to provide an apology, but they declined.