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Black Box Warning Ordered for Aranesp, Epogen, and Procrit
Black Box Warning Ordered for Aranesp, Epogen, and Procrit
http://www.procrit.com/HCP07.pdf
A New Boxed Warning providing the following information:
• Avoid serious cardiovascular and arterial and venous thromboembolic events by using the lowest dose of [Aranesp /EPOGEN/PROCRIT] that will gradually raise the hemoglobin concentration to the lowest level sufficient to avoid the need for blood transfusion
• [Aranesp /EPOGEN/PROCRIT] and other ESAs increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL
• Use of ESAs to achieve a target hemoglobin of 12 g/dL or greater in cancer patients:
• shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy;
http://www.medpagetoday.com/ProductA...ptions/tb/5231
ROCKVILLE, Md., March 9 -- The FDA warned today that aggressive use of erythropoiesis-stimulating agents to raise hemoglobin to a target of 12 g/dL or higher was associated with "serious and life-threatening side-effects and/or death."
I had some of this information posted somewhere else but I don't think it was being seen. I think this is the reason that they are changing the parameters for dosage. Please check out the full information at the links I provided.
Leslie
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In the world of destiny, there are no statistics.
Jan. 26- mammogram and ultrasound- suspicious lump
Mid-February- lumpectomy, infiltrating ductal carcinoma ~4.5 cm and a 1 cm DCIS, did not get clear margins, did not check lymph nodes
ER+/PR+, her2 +++, nuclear grade 3 of 3
February 20-PET scan showed something on liver. No biopsy.
March- Started carboplatin, herceptin, taxol on a four week cycle
May 3- Pet scan, with intent to do a biopsy, found nothing, liver or breast- no biopsy because there is nothing to biopsy
June 21- new onc, very concerned that there had been no biopsy,
June 18th-CAT scan, bone scan-negative
August 7th - Brain MRI-negative
August 9th- mastectomy, all pathology negative
January 2008 still NED! New oncologist -herceptin for full year after chemo- until July, and tamoxifen---negative scans since May '07
July 2008-Finished Herceptin!
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