Public Statement on Ziagen (Abacavir) - Abacavir hypersensitivity cases following an interruption of therapy

News 14/08/2000

The following public statement contains essential information for anyone prescribing or taking Ziagen (abacavir)1.

The European Agency's for the Evaluation of Medicinal Products (EMEA) scientific committee, the Committee for Proprietary Medicinal Products (CPMP), has recently been made aware of new information related to serious hypersensitivity reactions associated with Ziagen (abacavir).

Hypersensitivity reactions (HSR) are a known concern with this product. These potentially serious reactions are usually characterised by the appearance of symptoms indicating multi-organ system involvement. Nearly all the patients with HSR experience fever or rash but symptoms may mimic other common gastrointestinal or respiratory diseases. These reactions usually occur within the first 6 weeks of treatment, but can occur at any time, and were the subject of an urgent safety restriction in January of this year (please see EMEA public statement EMEA/1952/00 dated 24th January 2000 for further information).

Hypersensitivity reactions with rapid onset may occur when treatment with Ziagen is restarted in patients who were not previously diagnosed as having a hypersensitivity reaction. These patients typically had only one of the key symptoms of hypersensitivity (skin rash, fever, gastrointestinal, respiratory or constitutional symptoms such as lethargy and malaise) prior to stopping Ziagen. On very rare occasions hypersensitivity reactions have been reported in patients who have restarted therapy and who had no preceding symptoms of a hypersensitivity reaction.

The EMEA wishes to draw attention to the following updated information on the management of hypersensitivity reactions to Ziagen:

  • MANAGING HYPERSENSITIVITY REACTIONS -

- To avoid a delay in diagnosis and minimise the risk of a life threatening hypersensitivity reaction, Ziagen must be discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (respiratory diseases, flu-like illness, gastroenteritis or reactions to other medicines.) If re-introduction is judged necessary it must be done in a hospital setting.

- If a decision is made to re-start Ziagen in patients who had stopped for any other reasons (such as occurrence of only one of the key symptoms of hypersensitivity or no preceding symptoms of hypersensitivity prior to stopping Ziagen), this must be done in a setting where medical assistance is readily available.

  • INFORMING PATIENTS

- Patients must be made aware of the possibility of a hypersensitivity reaction to Ziagen and the need to contact their doctor immediately for advice should they develop signs or symptoms possibly linked to a hypersensitivity reaction.

- Patients who have stopped Ziagen due to symptoms which indicated or which were possibly due to a hypersensitivity reaction, should not restart Ziagen (or any other abacavir containing medicinal product) since restarting results in a return of symptoms within hours. The reoccurrence is usually more severe and may be lifethreatening or fatal.

- Patients who have stopped Ziagen for any reason, and particularly if due to possible adverse reactions or illness must be advised to contact their doctor before restarting.

- Patients should be reminded to read the package leaflet and to keep the alert card included in the pack with them at all times.

As an urgent measure, the prescribing and patient information and the labelling have 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.

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