Public Statement on Ziagen (Abacavir) - Important safety Information on Hypersensitivity Reactions and Respiratory Symptoms
News
The European Commission granted marketing authorisations for the European Union to Glaxo Group Ltd on 8 July 1999 for the medicinal product Ziagen®, which contains the active substance abacavir sulfate. Ziagen® is marketed in Austria, Denmark, Finland, France, Germany, Ireland, Italy, Portugal, Spain, Sweden and United Kingdom.
Ziagen® is an inhibitor of the reverse trancriptase of the HIV virus and indicated for antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults. The European Medicines Evaluation Agency's (EMEA) scientific committee, the Committee for Proprietary Medicinal Products (CPMP), has been evaluating new safety information as it emerges.
Hypersensitivity reactions (HSR) are the major points of concern with this product. These potentially serious reactions are characterised by the appearance of symptoms indicating multi-organ system involvement. Nearly all patients with HSR experience fever or rash. These reactions usually occur within the first 6 weeks of treatment.
Respiratory symptoms have been recognised as part of the hypersensitivity reaction in approximately 20% of HSR-patients, and may include dyspnoea, pharyngitis or cough in the initial presentation.
Deaths have occurred among patients initially thought to have acute respiratory diseases (pneumonia, bronchitis, or flu-like illness) who were only later recognised to have had a hypersensitivity reaction to abacavir that included respiratory symptoms. In cases where there was a fatal outcome respiratory symptoms were present in approximately 80% of the patients. A delay in diagnosis of hypersensitivity can result in Ziagen being continued or re-introduced, leading to more severe hypersensitivity reactions or to death.
Following a review of the above information, the EMEA wishes to draw attention to the following:
- Prescribers must ensure that patients are fully informed regarding hypersensitivity reactions. Each patient should be reminded to read the package leaflet and the alert card included in the pack.
- Some patients with hypersensitivity reactions were initially thought to have respiratory disease (pneumonia, bronchitis, pharyngitis) or a flu-like illness. Therefore, the diagnosis of hypersensitivity reaction should be carefully considered for patients presenting with symptoms of these diseases.
- Ziagen MUST NEVER be restarted in patients who have stopped therapy due to hypersensitivity reaction. · Restarting Ziagen must be avoided in patients in whom a hypersensitivity reaction cannot be excluded. · Patients experiencing TWO OR MORE symptoms of the following:
1) fever
2) shortness of breath, sore throat or cough
3) skin rash (redness and/or itching)
4) nausea or vomiting or diarrhoea or abdominal pain
5) severe tiredness or achiness or generally ill feeling
SHOULD CALL THEIR DOCTOR IMMEDIATELY for advice on whether they should stop taking Ziagen.
As an urgent measure, the prescribing and patient information has been modified through a rapid procedure at the request of the marketing authorisation holder. The EMEA thought it necessary to provide this new information to the public.
Relevant changes to the product information are indicated below. For the complete scientific evaluation of Ziagen® and the complete revised product information see the European Public Assessment Report, also available on the EMEA website.