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

ESAs can spur faster cancer growth and earlier death, agency says

THURSDAY, Jan. 3 (HealthDay News) -- Two new studies offer further evidence of the health risks posed by the anemia drugs known as erythropoiesis-stimulating agents (ESAs), U.S. officials announced Thursday.

The studies showed that patients with breast or advanced cervical cancer who took the drugs as treatment for chemotherapy-induced anemia died sooner or had more rapid tumor growth than patients not on the drugs, U.S. Food and Drug Administration officials said in a prepared statement.

On Nov. 8, the FDA approved new "black box" warnings on labels of the three ESAs -- Aranesp, Epogen and Procrit. The warnings detailed the dangers to patients with cancer and patients with chronic kidney failure. Those dangers include heart attack, stroke, heart failure and cancer tumor growth and shortened survival, the FDA said.

The drugs had been touted as a treatment to lessen fatigue and improve quality of life among cancer, HIV and other patients with anemia, but the revised label said there was no evidence to back that claim. The label change was the fifth such change since Procrit was approved in 1989, FDA officials said.

Results of the two studies released Thursday were not among the six studies that led to the Nov. 8 label revision. Taken together, all eight studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared to patients who didn't get this therapy, the FDA said.

The FDA said it plans to discuss the new findings and re-examine the risks and benefits of ESAs for patients with chemotherapy-induced anemia at a public advisory committee meeting in the next few months.

"This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous 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 cells. 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  

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:12/9/2016)... (PRWEB) , ... December 09, 2016 , ... ... Ball at The Pierre Hotel in New York, NY, on December 3rd, to ... dignitaries and physicians attended the annual event, which raised over $1 million - ...
(Date:12/8/2016)... WV (PRWEB) , ... December 08, 2016 , ... ... it will become Quality Insights beginning January 1, 2017. The name change ... its commitment to measuring and improving health care quality. , “We are very ...
(Date:12/8/2016)... ... 08, 2016 , ... ZyDoc , a New York-based ... Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study” ... comparative usability study demonstrate that a dictation-based method (“NLP Entry”) using ZyDoc’s MediSapien™ ...
(Date:12/8/2016)... ... 2016 , ... With the increasing demand for dental implants, the National Association ... to inform dentists and patients about the safety issues related to dental restorations. According ... the U.S. is projected to reach $6.4 billion in 2018 with more than 30 ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... continuity to its innovative Unified Instance Manager architecture, meeting the needs of ... new version optimizes the unattended auto-dialing system without agents, Presence Robodialer, provides ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... VIEW, Calif. , Dec. 8, 2016 IRIDEX ... intends to offer newly issued shares of common stock, $0.01 ... pursuant to an underwritten public offering.  The final terms of ... the time of pricing, and there can be no assurance ... IRIDEX expects to use the net proceeds it ...
(Date:12/8/2016)... Australia Glaucoma Surgery Devices Market Outlook ... "Australia Glaucoma Surgery Devices Market Outlook to 2022", ... Surgery Devices market. The report provides value, in ... average prices (USD) within market segement - Glaucoma ... shares and distribution shares data for each of ...
(Date:12/8/2016)... -- The global biosurgery market is expected to grow at ... 2016 to 2021. The market is poised to reach ... in 2016. The market is primarily driven by rising ... and spinal problems, increasing clearance of biosurgery products by ... management. In this report, the biosurgery market ...
Breaking Medicine Technology: