Navigation Links
FDA Reports New Risks Posed by Anemia Drugs
Date:1/3/2008

ous communications," Dr. Janet Woodcock, the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research, said in the statement.

"FDA is reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients."

According to the FDA statement:

  • On Nov. 30, Amgen Inc., manufacturer of the three ESAs -- Aranesp, Epogen, and Procrit -- provided the FDA with information from the 733-patient PREPARE study of women who received chemotherapy before undergoing surgery for breast cancer. After three years, 14 percent of the patients who received Aranesp to treat their anemia had died, compared to 9.8 percent who did not get the drug. Tumor growth was also faster in patients receiving Aranesp.
  • On Dec. 4, Amgen informed the FDA of the results of a study by the National Cancer Institute's Gynecologic Oncology Group of patients receiving chemotherapy and radiation for advanced cervical cancer. The patients were given either Procrit to maintain hemoglobin levels above 12 grams per deciliter of blood or blood transfusions as needed. After three years, 66 percent of the patients who did not take Procrit were alive and free of cancer growth, compared to 58 percent who had received the drug.

In announcing the label revision in November, Dr. John Jenkins, director of the FDA's Office of New Drugs, said, "We are emphasizing that ESAs should be used at the lowest dose necessary to avoid blood transfusions, since that is the only identifiable benefit for ESAs. Doctors should have discussions with their patients about whether to use ESAs at all."

The three drugs are synthetic versions of a protein made in the kidney that tells bone marrow to produce red blood c
'/>"/>

Copyright©2008 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Lincare Holdings Inc. Reports Intention to File Shelf Registration Statement
2. UCI Medical Affiliates, Inc. Reports Fiscal Year End Results for September 30, 2007
3. The Ensign Group, Inc. Reports Third Quarter 2007 Earnings
4. HealthPartners Reports 2007 Most Cost Effective Programs Reduce Expenses by $74 Million
5. Par Pharmaceutical Reports Third-Quarter 2007 Results
6. Briggs & Riley Reports That More Travelers Focus on Health and Sanitation This Holiday Season
7. Recent Reports Underscore the Importance of Testing Supplements for Athletic Banned Substances
8. Intensive care quality of sleep improved by new drug, reports study
9. Biodel Inc. Reports Fourth Quarter and Fiscal Year 2007 Financial Results
10. IBM reports milestone in silicon nanophotonics
11. Telik Reports Positive Results From Phase 1 Dose-Escalation Study of TELINTRA Tablets in Myelodysplastic Syndrome
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Reports New Risks Posed by Anemia Drugs
(Date:9/18/2014)... is good for you. But new research from University ... added benefit for cancer patients undergoing chemotherapy. , Their ... that combining exercise with chemotherapy shrunk tumors more than ... in the School of Nursing and director of the ... senior author on the study, which appears in the ...
(Date:9/18/2014)... September 18, 2014 TayganPoint Consulting ... today that President and co-founder John Cassimatis was ... Award Winners for 2014, recognizing the region’s top ... an emerging executive of the year. , The ... life sciences that continue to shape the medical ...
(Date:9/18/2014)... September 18, 2014 Ben Quirk, CEO ... Ormond, Jr. Leadership Award by the Savannah Science Seminar ... and wellness throughout the nation and especially in Savannah. ... award,” said Ben. “The Savannah Science Seminar is an ... and multiple generations have gone through the program,” he ...
(Date:9/18/2014)... new method to study Ebola virus in wildlife. Video ... (WCS)-led research, published today in the journal PLOS ... samples from wild great apes to identify populations likely ... a new tool for performing large, population-scale field assessments ... studied and improve our understanding of the virus, distribution ...
(Date:9/18/2014)... The National Institutes of Health (NIH) recently awarded the ... grant to the Los Angeles Biomedical Research Institute (LA ... a vaccine to protect patients from the healthcare-related infections, ... (MRSA). , The National Institute of Allergy and ... to LA BioMed infectious disease specialists John E. Edwards, ...
Breaking Medicine News(10 mins):Health News:Exercise boosts tumor-fighting ability of chemotherapy, Penn team finds 2Health News:TayganPoint Executive Receives Prestigious Award from Philadelphia Business Journal 2Health News:Quirk Awarded the Alex Ormond, Jr. Leadership Award by the Savannah Science Seminar 2Health News:Research yields a game changer for improving understanding of Ebola and great apes 2Health News:Research yields a game changer for improving understanding of Ebola and great apes 3Health News:LA BioMed receives NIH grant to study vaccine for hospital-acquired infections 2
... ITASCA, Ill., March 20 Arthur J. ... Healthcare Risk Solutions, LLC,headquartered in Fort Washington, ... Founded in 2002, Healthcare Risk Solutions, ... professional liability insurance,products, associated risk mitigation consulting ...
... PRGO ; TASE) today announced that the ... Jersey has denied Connetics Corporation,s motion,for a preliminary ... generic equivalent to Connetics, Olux(R) Foam and has,lifted ... launching,the product. The Court also denied Perrigo,s motion ...
... emotional well-being, study suggests , , THURSDAY, March 20 (HealthDay ... health of the husband -- as either patient or ... of mind, new research suggests. , The finding suggests ... his wife,s experience of psychological distress more so than ...
... WASHINGTON, March 20 Veterans in seven,additional states ... Department of Veterans Affairs (VA) plan to open 14 ... James B. Peake today,announced that VA will establish new ... "VA is dedicated to providing the best in ...
... was a rainy,Saturday, nothing could dampen the spirits ... Free Families (DCTFF) hosted a special evening at,Saturday,s ... over 100 D.C.,residents who have quit smoking using ... Health Care, Inc., (Photo: http://www.newscom.com/cgi-bin/prnh/20080320/NETH063 ...
... halve by 2015 the number of people without toilet access ... every dollar spent installing toilets in developing countries, there would ... according to a UN report released today. , The UN ... 2015 the number of people worldwide who don,t have access ...
Cached Medicine News:Health News:Perrigo Company Announces Launch of Clobetasol Propionate Foam 2Health News:Perrigo Company Announces Launch of Clobetasol Propionate Foam 3Health News:Cancer Poses Challenges for Husbands' Frame of Mind 2Health News:Cancer Poses Challenges for Husbands' Frame of Mind 3Health News:VA to Open 14 New Clinics in Seven States 2Health News:Quitters Honored at Wizards' DC Tobacco Free Family Night 2Health News:Cleaning Up the World's Sanitation 2
(Date:9/18/2014)... , Sept. 18, 2014   Fruit Street ... secured an initial seed round of funding. ... was led by a series of individual investors, the ... whom participated in the initial round are; Houston ... Medical Center Urologist Stacy Childs, Rapha Family Medicine Practice ...
(Date:9/18/2014)... Pharma IQ, after huge demand ... Countdown calendar to cover the years 2014 - 2018 ... shows the serialisation requirements around the globe and the ... For companies dealing with international markets, serialisation ... they will have to comply with new regulations coming ...
(Date:9/18/2014)... , Sept. 18, 2014   3D Systems   (NYSE: ... Simbionix RobotiX Mentor™ , a new robotic surgery skills ... first time at the ERUS exhibition in Amsterdam, ... #7). Robotic-assisted minimally invasive surgery represents a growing ... the needs for training for robotic surgery has increased, and ...
Breaking Medicine Technology:Fruit Street Health Secures First Round Of Seed Funding Led By Group Of Medical Industry And Technology Leaders 2Fruit Street Health Secures First Round Of Seed Funding Led By Group Of Medical Industry And Technology Leaders 3Pharma IQ Displays Worldwide Serialisation Deadlines in their 2014 - 2018 Countdown Calendar 23D Systems Introduces New Simbionix Robotics Training Platform 23D Systems Introduces New Simbionix Robotics Training Platform 3
... Biomerix Corporation announced today that it has received ... mesh allowing for the marketing of REVIVE in all ... clearance from the U.S. Food and Drug Administration (FDA) ... the Biomerix Biomaterial™, a proprietary, biointegrative synthetic tissue scaffold. ...
... ANNAPOLIS, Md., Jan. 24, 2011 PharmAthene, Inc. (NYSE Amex: ... the Delaware Court of Chancery, which commenced January 3, 2011, ... this past Friday, January 21, 2011. The Company anticipates that ... in front of the court will be complete by the ...
Cached Medicine Technology:Biomerix Granted CE Mark for its REVIVE™ Soft Tissue Repair Mesh 2PharmAthene Provides Update on Litigation With SIGA Technologies 2
Used to negotiate tortuous vessels....
BiodivYsio stent with biocompatible coating (phosphorylcholine)...
... The CYPHER Sirolimus-eluting Coronary Stent ... drug, called "sirolimus", a controlled-release ... delivery platform. Upon placement, sirolimus ... and impedes the process of ...
PT wires combine the enhanced durability of a linear elastic nitinol distal core and a highly resilient polymer tip. This provides excellent access in difficult cases involving severe tortuosity, tig...
Medicine Products: