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Recent News and Articles on the Keywords: anemia + drugs + 4,990  Related to the article below (Last Update: 8/5/2008)

Treatment With Anti-anemia Drugs May Not Be Safe For Multiple ...
Science Daily (press release) -
... that Erythropoiesis-stimulating agents (ESAs), a widely used drug to treat anemia, may have a negative impact on the survival of myeloma patients. ...

Ontario Now
Amgen anemia drug label change has little impact
Forbes, NY - Jul 31, 2008
AP 07.31.08, 10:44 AM ET Wall Street brushed off concerns over new labeling for Amgen's troubled anemia drugs Thursday, with many analysts saying the ...
FDA: More Label Warnings for Anemia Drugs TheStreet.com
US FDA orders Amgen to add new anemia drug warning guardian.co.uk
FDA Orders Changes In Labeling of Anemia Drug Wall Street Journal
New York Times - Ontario Now
all 222 news articles »  AMGN - JNJ
International Sales Stabilize Amgen
Forbes, NY - Jul 28, 2008
Fortunately, Amgen didn't have any new problems with anemia drugs Epogen and Aranesp during the quarter. Earlier in the year, the US Food and Drug ...AMGN
Stocks dive in response to housing rescue plan
Los Angeles Times, CA - Jul 29, 2008
With sales of its lucrative anti-anemia drugs Aranesp and Epogen waning because of health risks associated with the treatments, Amgen has been in need of a ...

Los Angeles Times
Wall St. is back in love with Amgen on bone-drug hopes
Los Angeles Times, CA - Jul 28, 2008
With sales of its lucrative anti-anemia drugs Aranesp and Epogen tumbling because of health risks now associated with the treatments, Amgen has needed a new ...AMGN
Amgen shares, propped by bone drug, may move higher
guardian.co.uk, UK - Aug 1, 2008
The uptick reverses a slide that began early last year after studies emerged showing that anemia drugs, Amgen's biggest sellers, raised the risk of death ...AMGN
Amgen 2nd-qtr profit falls but tops Wall Street
guardian.co.uk, UK - Jul 28, 2008
By Bill Berkrot NEW YORK, July 28 (Reuters) - Amgen Inc reported a better-than-expected quarterly profit on a surprising rebound in sales of its anemia drug ...AMGN
Bone Drug Boosts Amgen Growth Prospects
TheStreet.com - Jul 28, 2008
The success of the denosumab study is welcome news for Amgen after 18 months of woes tied to falling sales of its anemia drugs. Denosumab has the potential ...AMGN
Amgen Climbs on Profit Beat (Update)
TheStreet.com - Jul 28, 2008
The earnings beat, supported by better-than-expected sales of the biotech company's beleaguered anemia drugs, came on the tail of positive late-stage trial ...AMGN
UPDATE: Amgen 2Q Profit Beats Street On Anemia Drug Sales
CNNMoney.com - Jul 28, 2008
Earlier this month, Johnson & Johnson reported second-quarter sales of its anemia drugs Procrit and Eprex fell 14% to $652 million . ...AMGN
Source: Google News

… and Chloroquine Completely Cures Blood-Stage Malaria, Prevents Severe Anemia, and Induces Immunity … -
K Mohan, H Sam, MM Stevenson - Infection and Immunity, 1999 - pubmedcentral.nih.gov
... [PubMed]. 4. Doherty TM, Sher A. IL-12 promotes drug-induced clearance ... 1997;159:4990?
4998. ... K, Stevenson M M. Interleukin 12 corrects severe anemia during blood ...

Treatment of severe refractory autoimmune hemolytic anemia in B-cell chronic lymphocytic leukemia … -
C Karlsson, L Hansson, F Celsing, J Lundin - Leukemia, 2007 - nature.com
... corticosteroids, followed by cytotoxic drugs, intravenous (iv ... chronic lymphocytic
leukemia patients with autoimmune hemolytic anemia. ... Blood 1996; 87: 4990?4997 ...

Hemolytic uremic syndrome in small-bowel transplant recipients: the first two case reports -
A Humar, J Jessurun, HL Sharp, RWG Gruessner - Transplant International, 1999 - Springer
... rise in the serum LDH level to 4990 U/l ... such as rapamycin may allow such drugs as
CSA ... by healing of intestinal ulcers, resolution of anemia and thrombocytopenia ...

… and safety of low-dose alemtuzumab as treatment of autoimmune hemolytic anemia in pretreated B-cell … -
L Laurenti, M Tarnani, DG Efremov, P Chiusolo, L … - Leukemia, 2007 - nature.com
... Blood 1996; 87: 4990?4997. ... Autoimmune hemolytic anemia in chronic lymphocytic
leukemia: clinical, therapeutic, and prognostic features. ...

Chronic Lympthocytic Leukemia Treatment of severe refractory autoimmune hemolytic anemia in B-cell …
C Karlsson, L Hansson, F Celsing, J Lundin - Leukemia, 2007 - nature.com
... corticosteroids, followed by cytotoxic drugs, intravenous (iv ... chronic lymphocytic
leukemia patients with autoimmune hemolytic anemia. ... Blood 1996; 87: 4990?4997 ...
-

Identifying DNA Methylation Biomarkers of Cancer Drug Response. -
S Maier, C Dahlstroem, C Haefliger, A Plum, C … - American Journal of PharmacoGenomics, 2005 - pharmacogenomics.adisonline.com
... Disruption of the Fanconi anemia-BRCA pathway in cisplatin ... Science 1991 Jan 11; 251
(4990): 186-9 ... Histone-deacetylase inhibitors: novel drugs for the treatment ...

Cladribine combined with cyclophosphamide is highly effective in the treatment of chronic … -
T Robak, JZ Blonski, M Kasznicki, J Gora-Tybor, J … - The Hematology Journal, 2002 - online.haematologica.org
... Anemia 4 (4.8) 6 (1.8) 2 (2.4) 5 (1.5) 6 (7.3) 11 (3.3) ... Although the daily dose of
this drug (0.12 mg/kg), remained the same as in ... Blood 1996; 87: 4990 ? 4997 ...

Rituximab Followed by Cladribine in the Treatment of Heavily Pretreated Patients with Indolent … -
T Robak, P Smolewski, H Urbanska-Rys, J Gora-Tybor … - Leukemia and Lymphoma, 2004 - informaworld.com
... Anemia 1 (6.7%)-grade I ? II 2 (5.1%) 1 ... to the cytotoxic activity of either drug
alone??, British ... diagnosis and treatment??, Blood, 87, 4990 ? 4997 ...

IS THERE A RELATIONSHIP BETWEEN IN VITRO DRUG RESISTANCE AND LEVEL OF MINIMAL RESIDUAL DISEASE AS … -
H DE, GJL KASPERS, L OOSTEN, D BRESTERS, R PIETERS … - British Journal of Haematology, 2002 - pt.wkhealth.com
... CD20 monoclonal antibody for the treatment of severe, immune- mediated, pure red
cell aplasia and anemia. ... Blood, 87, 4990?4997. ... Drugs and Ageing, 16, 9?27. ...

[PDF] DRUGS-ABOUT. COM -
P Insert - drugs-about.com
... microangiopathic hemolytic anemia with thrombocytopenia. Pregnancy Category D ... lethality
and abortion in rabbits when given at doses that result in plasma drug ...

Source: Google Scholar
 

US FDA staff cautious on anemia drugs' risks

Last Updated: 2007-05-08 16:34:20 -0400 (Reuters Health)

By Susan Heavey

WASHINGTON - U.S. Food and Drug Administration staffers are still cautious over the use of anemia drugs sold by Amgen Inc. and Johnson & Johnson, according to an agency document released on Tuesday.

More data is needed on risks with the injectable drugs, which include Amgen's Aranesp and Epogen and J&J's Procrit, the staff said. Changes to the products' labels to restrict which patients should use them or further limit dosing may also be appropriate, they added.

The agency document was released ahead of an FDA advisory panel meeting on Thursday to discuss the risks of using the medicines in cancer patients amid recent concerns that they are used too aggressively and may harm patients.

Article continues below and (thank you)
 

In March, FDA officials called for a strong new warning on the medicines and urged doctors to use the lowest dose needed to avoid blood transfusions.

All three drugs are man-made forms of the natural protein erythropoietin and are approved to treat anemia in cancer patients receiving chemotherapy.

They are also cleared for patients with chronic kidney failure and treat anemia by boosting production of hemoglobin - an oxygen-carrying protein in red blood cells.

In its review, FDA staff said the uncertainty of the drugs' risks when used as labeled has not been well addressed in the past three years.

"Additional efforts should be made to obtain such information in a timely manner," the staff wrote. They added that the medicines' ability to help patients avoid transfusions "should continue to be weighed against the potential for detrimental effects on survival and tumor growth."

A number of studies showed an increased risk of thrombovascular problems, which can include heart attacks and strokes, they added.

PHARMACOVIGILANCE

Separately, Amgen and J&J said they had conducted a comprehensive review and analysis of the available safety data, which they said supports use of anemia drugs as labeled.

"Ongoing pharmacovigilance studies will further inform the risk/benefit assessment in the near future," they said in another document released on Tuesday.

It is unclear what impact Thursday's meeting may have on the blockbuster drugs, and analysts have been mixed over whether the FDA's outside experts will dwell on the drugs' risks or reaffirm some of their benefits. The agency usually follows the recommendations of its advisers.

The panel's review could also have implications for Roche Holding AG, which is expecting an FDA approval decision for its rival product Mircera later this month.

Copyright © 2007 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

 
 
 
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