Adverse Drug Reactions
Bayer Establishes US Special Access Program for Leukine(R) While Replacing Current Liquid Formulation
Published in FDA Law Weekly, February 7th, 2008
Bayer HealthCare Pharmaceuticals Inc. announced, following consultation with the United States Food and Drug Administration (FDA), that it will withdraw the current liquid formulation of Leukine(R) marketed in the US. 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 currently contains EDTA (edetate disodium).
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...
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Source: FDA Law Weekly (2008-02-07)
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