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Recall of GM-CSF

The following was written by Linda Pilkington:

logo_bayer.jpg"German powerhouse Bayer is to pull a formulation of its anti-infective Leukine (sargramostim) from the USA following a spike in the number of adverse events reported, particularly fainting and hypotension.

Bayer says that the rise in AEs corresponds to a formulation change to include edetate disodium, a chelator that is approved separately in the USA as an emergency treatment to combat high levels of calcium in the blood or heart rhythm problems following digitalis poisoning.

The firm says it now plans to reformulate the 500mcg vial - the only one to include EDTA - and will open a special access programme to enable patients with life threatening conditions preferential treatment using the 250mcg vial, which does not contain the substance in question.

Leukine is a growth factor designed to boost the immune system and combat infections in AML and transplantation patients."

Full details can be found at Bayer's  press release.

Posted on Monday, February 4, 2008 at 08:28AM by Registered CommenterDr Lynn Spitler | Comments1 Comment

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Reader Comments (1)

thats for sure, dude

March 20, 2008 | Unregistered CommenterSharonuu

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