Bayer Withdraws Leukine Formulation that Contains EDTA

February 12, 2008
BioPharm International Editors

Bayer HealthCare (Leverkusen, Germany) has withdrawn the current liquid formulation of Leukine marketed in the US following consultation with the US Food and Drug Administration (FDA).

Bayer HealthCare (Leverkusen, Germany) has withdrawn the current liquid formulation of Leukine marketed in the US following consultation with the US Food and Drug Administration (FDA). This decision was made in light of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with the liquid Leukine 500 mcg vial, which contains EDTA (edetate disodium).

The upward trend in adverse event reporting rates is only associated with the Leukine liquid 500 mcg vial containing EDTA. Bayer has not observed an upward trend in reporting rates of these adverse events in the marketed Leukine 250 mcg lyophilized vial which does not contain EDTA. These adverse reactions are listed in the Leukine prescribing information.

While Bayer works to increase supplies of lyophilized Leukine and reformulate the liquid Leukine (to eliminate EDTA), Bayer will establish a special access program for the currently marketed lyophilized Leukine 250 mcg vial, which does not contain EDTA.

The timing of increased reporting of these adverse events coincides with a change in the formulation of liquid Leukine to include EDTA. Leukine has been used to treat nearly 350,000 patients in the US since 1991 and remains an important therapeutic option for many patients.

Bayer press release

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