EMEA public statement on Refludan (Lepirudin) - Fatal anaphylactic reactions
News
Refludan contains lepirudin, a recombinant hirudin, which acts as a specific direct inhibitor of free and clot-bound thrombin. It is indicated as an anticoagulant in adult patients suffering from heparinassociated thrombocytopenia (HAT) type II with thromboembolic disease mandating parenteral antithrombotic treatment. It was authorised in the European Union in 1997 and is currently marketed within the EU in Greece, Austria, UK, Ireland, Finland, Spain, Belgium, France and Germany. Altogether, approximately 35,000 patients have been treated with Refludan.
The European Medicines Evaluation Agency (EMEA) and its Scientific Committee CPMP have been made aware of seven recent reports of severe anaphylactic reactions in patients receiving Refludan. In six of these cases, the anaphylactic reaction occurred after re-exposure to Refludan. The patient died in five of these cases. In several of the reported cases, Refludan was prescribed outside the approved therapeutic indication.
The EMEA wishes to highlight the following important safety information:
For physicians considering treating patients with Refludan:
- The approved indication is for the anticoagulation of adult patients with heparin-associated thrombocytopenia (HAT) type II with thromboembolic disease mandating parenteral antithrombotic treatment.
- Refludan may cause allergic reactions including anaphylaxis.
- Anaphylactic reactions resulting in fatality have been reported in patients re-exposed to Refludan in a second or subsequent treatment course. Before taking the decision to re-expose a patient to Refludan, alternative treatment options must be considered.
- As these anaphylactic reactions are immune-mediated, patients with recent exposure to Refludan, other hirudins or hirudin analogues may be at increased risk
- Prescribers should ask their patient if she/he has had any prior exposure to Refludan, other hirudins or hirudin analogues.
- Treatment with Refludan should be undertaken only in a setting where medical assistance is readily available and where there is access to treatment for anaphylactic shock.
- Patients should be informed that they have been treated with Refludan and that they should inform any future prescribers of this fact.
Information for patients
Please tell your doctor if you have ever received Refludan, hirudin or a hirudin analogue.
As an urgent measure, the prescribing and patient information has been modified through a rapid procedure. The revised product information is available in the European Public Assessment Report of Refludan published on the EMEA Website.