Bayer  HealthCare (Leverkusen, Germany) has withdrawn the current liquid  formulation of Leukine marketed in the US following consultation with the  US Food and Drug Administration (FDA).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

News

Bayer HealthCare (Leverkusen, Germany) has withdrawn the current liquid formulation of Leukine marketed in the US following consultation with the US Food and Drug Administration (FDA).