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

ells. The drugs are manufactured by Amgen, of Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J., a subsidiary of Johnson & Johnson.

For cancer patients, November's revised warnings emphasized that the drugs can cause tumor growth and reduce survival among patients with advanced breast, head and neck, lymphoid and non-small cell lung tumors. This is especially true when the dose is designed to produce a hemoglobin level of 12 grams per deciliter of blood or more.

For hemoglobin levels less than 12 grams per deciliter, the label says there's no evidence to determine if the drugs cause any of these problems, the FDA said.

The revised label also made it clear that ESAs should be used in cancer patients only when their anemia is caused by chemotherapy and not from other causes. Also, ESAs should be stopped when the patient's chemotherapy has ended, the FDA said.

The revised label also said there's no evidence that ESAs improve symptoms of anemia, quality of life, fatigue, or patient well-being in cancer patients or patients with HIV taking the drug AZT.

More information

For more information on ESAs, visit the U.S. Food and Drug Administration.



SOURCES: Jan. 3, 2008, news release, U.S. Food and Drug Administration; Nov. 8, 2007, teleconference with Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; John Jenkins, M.D., director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
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:7/31/2015)... ... ... Down is a reputable source of authentic tickets for the 2015 iHeart Radio Music ... genre of music will have an act they are excited to see at this two-day ... artists will perform: Sam Smith, Coldplay, Kenny Chesney, The Who, Jason Derulo, Demi Lovato, ...
(Date:7/31/2015)... ... ... The Honor Society of Nursing, Sigma Theta Tau International (STTI) convened a ... July 2015 in San Juan, Puerto Rico. Key nurse leaders from Central and Latin ... Nursing and Allied Health Personnel Development, Unit of Human Resources for Health, Department of ...
(Date:7/31/2015)... (PRWEB) , ... July 31, 2015 , ... Ticket Down ... is currently going on in Chicago at Grant Park. The festival will end ... of North America to Chicago for the annual Lollapalooza. This unique and unbelievably ...
(Date:7/31/2015)... ... 2015 , ... Recently touted by Becker’s Healthcare as one ... , Jvion continues to disrupt the predictive analytic and big data market using ... population level illness to drive prevention and better health outcomes. Most recently, Jvion ...
(Date:7/31/2015)... ... , ... The 2nd annual Ride to Fight On will start and end ... The Ride to Fight On is a cycling fundraiser that benefits the West Cancer ... and The University of Tennessee Health Science Center. A health and wellness festival featuring ...
Breaking Medicine News(10 mins):Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 2Health News:Cheap 2015 iHeartRadio Music Festival Tickets in Las Vegas at MGM Grand Garden Arena: Ticket Down Slashes Ticket Prices on the iHeart Radio Music Festival in Vegas 3Health News:Key Latin American Nurse Leaders Identify Regional Issues During Global Advisory Panel on the Future of Nursing Meeting 2Health News:Key Latin American Nurse Leaders Identify Regional Issues During Global Advisory Panel on the Future of Nursing Meeting 3Health News:Key Latin American Nurse Leaders Identify Regional Issues During Global Advisory Panel on the Future of Nursing Meeting 4Health News:Cheap 2015 Lollapalooza Tickets: Ticket Down Slashes Ticket Prices on Lollapalooza Tickets at Grant Park in Chicago for Saturday, August 1st and Sunday, August 2nd 2Health News:Jvion Showcased as Leader in the Predictive Analytic Market 2Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 2Health News:West Cancer Center Announces 2nd Annual Ride to Fight On 3
... Scientists working at the Medical Research Council have identified ... pre-cancerous cells in the esophagus, a condition called Barrett,s ... these cells before they develop into esophageal cancer. These ... have important implications for patients and may help to ...
... News) -- Soccer players need to use the correct ... or redirect the ball -- to prevent possible brain injury, ... link between the sport and brain damage, Dr. Alejandro Spiotta ... are moving at high speeds when they come into contact ...
... -- A study about how wearing contact lenses affects ... Loyola University Chicago Stritch School of Medicine,s annual St. ... study is Marie Brenner, a fourth-year student at Stritch ... effects of contact lens wear on retinal nerve fiber ...
... an accepted way to simplify a complex array of symptoms ... an independent disease in itself. However, the truth is not ... at work explaining the symptoms. This is also one of ... not bring the hoped result," says Kari Tikkinen, MD, PhD, ...
... The University of Kentucky will be the first site ... the entire country participating in the first stages of a ... human adult stem cell product, on patients with acute ischemic ... stroke protocol B01-02, was recently approved by UK,s institutional review ...
... By Alan Mozes HealthDay Reporter , ... smartphone may not actually be that smart, British researchers ... study that finds an association between the increasingly popular ... levels. The reason: a relentless need to immediately ...
Cached Medicine News:Health News:Researchers use sugar to halt esophageal cancer in its tracks 2Health News:Heading Soccer Balls Could Injure Brain 2Health News:The concept of 'overactive bladder' serves better commercial rather than patient interests 2Health News:Your Smartphone May Be Stressing You Out 2Health News:Your Smartphone May Be Stressing You Out 3
(Date:7/30/2015)... OAKS, Calif., July 30, 2015  Amgen (NASDAQ: ... the second quarter of 2015. Key results include: ... the second quarter of 2014 to $5,370 million, ... by Enbrel ® (etanercept), Prolia ® ... (carfilzomib) and XGEVA ® (denosumab). Unfavorable changes ...
(Date:7/30/2015)... Tianyin Pharmaceutical Inc. (NYSE Amex: TPI ... the patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded ... the notice it received on May 21, 2015 from ... Company was below certain of the Exchange,s continued listing ... of the NYSE MKT Company Guide, due to the ...
(Date:7/30/2015)... , July 30, 2015  Growth of the U.S. ... they bring former prescription users to the OTC market. ... forecasts robust Rx-to-OTC switch activity over the next ... along with many new brands entering the market into ... the next five years (even those with low to ...
Breaking Medicine Technology:Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 2Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 3Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 4Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 5Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 6Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 7Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 8Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 9Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 10Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 11Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 12Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 13Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 14Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 15Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 16Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 17Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 18Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 19Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 20Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 21Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 22Amgen's Second Quarter 2015 Revenues Increased 4 Percent To $5.4 Billion And Adjusted Earnings Per Share (EPS) Increased 8 Percent To $2.57 23TPI Provides Update Regarding Non-Compliance with NYSE MKT Continued Listing Requirements 2Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 2Rx-to-OTC Switches -- Game Changers for the U.S. OTC Drugs Market through 2019, Sees Kline 3
... Company (NYSE:  KVa/KVb) announced today that it has entered into ... II, L.L.C. for a $20 million loan secured by assets ... loan for working capital and general operating purposes.   ... L.L.C. and U.S. Healthcare II, L.L.C., has entered into a ...
... leader in centralized expert evaluation of CNS disorders, announced ... has approved the first New Drug Application (NDA) for ... MedAvante centralized raters. Johnson and Johnson Pharmaceutical ... for the drug paliperidone palmitate, now known as Invega ...
Cached Medicine Technology:K-V Pharmaceutical Company Secures $20 Million Loan 2K-V Pharmaceutical Company Secures $20 Million Loan 3K-V Pharmaceutical Company Secures $20 Million Loan 4K-V Pharmaceutical Company Secures $20 Million Loan 5K-V Pharmaceutical Company Secures $20 Million Loan 6K-V Pharmaceutical Company Secures $20 Million Loan 7K-V Pharmaceutical Company Secures $20 Million Loan 8FDA Approves NDA That Includes Psychiatric Data Collected by Centralized Raters 2FDA Approves NDA That Includes Psychiatric Data Collected by Centralized Raters 3
For the quantitative determination of Uric Acid in serum. Linearity: 25 mg/dl....
... for continuous, random access operation, the Elecsys ... to large volume laboratories that want to ... the simplicity, flexibility and Stat capabilities of ... be adapted to the changing needs of ...
The Dimension RxL Max is an integrated chemistry system and is the most powerful and technologically advanced Dimension analyze with new standard for excellence in clinical diagnostics. Simply put, t...
... The SkanWasher 400 ... 96-well microplate washer with ... pumps. The individual pressure ... a very gentle wash ...
Medicine Products: