Epo/Procrit/Aranesp Warning

[Guest guest]

Hi all,

Just an FYI. Please note that these new warnings apply mainly to people

with chronic renal failure. But I thought this might be of interest to

you anyway.

~ G.

The FDA Safety Information and Adverse Event Reporting Program

Amgen, Ortho Biotech and FDA notified healthcare professionals of

revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND

ADMINISTRATION sections of the prescribing information for these three

products. The revised labeling provides updated safety information on

reports of pure red cell aplasia and severe anemia, with or without

other cytopenias, associated with neutralizing antibodies to

erythropoietin in patients treated with these products. This has been

reported predominantly in patients with CRF receiving these products by

subcutaneous administration. Recommendations for evaluation and

treatment are provided in the new prescribing information.

Read the complete MedWatch 2005 Safety summary, including links to the

Dear Healthcare Professional letters and revised prescribing information

at:

<http://www.fda.gov/medwatch/safety/2005/safety05.htm>

http://www.fda.gov/medwatch/safety/2005/safety05.htm#aranesp2

and

<http://www.fda.gov/medwatch/safety/2005/safety05.htm>

http://www.fda.gov/medwatch/safety/2005/safety05.htm#epoetin