Navigation Links
FDA Issues New Warnings for Anemia Drugs
Date:11/8/2007

ESAs can increase cancer growth, cause stroke and heart attacks, revised label warns

THURSDAY, Nov. 8 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved new "black box" warnings on labels of erythropoiesis-stimulating agents, which are drugs used to treat certain types of anemia.

The warnings cover the drugs Aranesp, Epogen and Procrit, and detail their 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 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 new label says there's no evidence to back that claim.

"Today's labeling changes are being made to make clear recommendations about the safe and effective use of these products and to strengthen the information about the risks that these drugs pose to patients with cancer and to patients with chromic kidney failure," Dr. Richard Pazdur, the FDA's director of the Office of Oncology Drug Products at the Center for Drug Evaluation and Research, said at a Thursday teleconference.

This is the fifth time the FDA has called for label changes for these drugs -- also known as ESAs -- since Procrit was approved in 1989, Pazdur 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," Dr. John Jenkins, director of the FDA's Office of New Drugs. "Doctors should have discussions with their patients about whether to use ESAs at all."

These 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 Inc., of Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J., a subsidiary of Johnson & Johnson.

Dr. Roger M. Perlmutter, Amgen's executive vice president of research and development, said in a prepared statement that his company "has been working closely with the FDA and J&JPRD [Pharmaceutical Research and Development] to ensure that the information contained in the approved labeling for ESAs accurately reflects the current state of knowledge of these important products and to develop a comprehensive and feasible clinical study program to complement our existing pharmacovigilance program.

"In the current label revisions, we have endeavored to include as much information as possible so physicians and their patients can make informed treatment decisions," he added.

For cancer patients, the new warnings emphasize 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 will say there is no evidence to determine if the drugs cause any of these problems, the FDA said.

"We recommend that prescribers talk to their patients about the risks that ESAs might cause cancer to grow or shorten survival before they prescribe these drugs or continue ESA therapy, Pazdur said. "The risks should be weighed against blood transfusions and their associated risks."

The new label will also make 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.

For patients with chronic kidney failure, the new black box warning says that ESAs should be used to keep hemoglobin levels between 10 grams per deciliter to 12 grams per deciliter. Higher hemoglobin levels in these patients can increase the risk for death, stroke, heart attack or heart failure, the FDA said.

The new labeling also gives instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment.

The new label also says there is 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.

"There are no data from controlled trials demonstrating that ESAs improve symptoms of anemia, quality of life, fatigue or patient well-being," Pazdur said.

The FDA is working with Amgen on new clinical trails and is also reviewing a Medication Guide that will explain the use of these drugs to patients, Pazdur said.

Epogen, Procrit and Aranesp are used to treat anemia in patients with chronic kidney failure and anemia caused by chemotherapy in some cancer patients. Epogen and Procrit are also used in some anemic patients who are undergoing surgery to reduce the need for blood transfusions. These drugs are also used to treat anemia in HIV patients taking AZT.

More information

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



SOURCES: 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; Nov. 8, 2007, prepared statement, Roger M. Perlmutter, M.D., Ph.D., executive vice president of research and development, Amgen, Thousand Oaks, Calif.


'/>"/>
Copyright©2007 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. College Mental Health Expert and Sister of Student Who Died By Suicide Available to Discuss College Mental Health Issues
2. PowerBar Issues Open Call for 2008-2009 PowerBar Team Elite(TM) Athlete Sponsorship Program
3. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Tapestry Pharmaceuticals, Inc.
4. American Red Cross Issues Blood Supply Alert
5. OSHA Issues Draft Ergonomics Guidelines on Preventing Musculoskeletal Injuries in Shipyards
6. New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
7. National Quality Forum Issues First Consensus Standards for the Treatment of Substance Use Conditions
8. Audio: New Survey Finds Strong Public Interest in Prescription Drug Safety Issues
9. Dallas-Area Transplant Meeting Puts Spotlight on Key Issues
10. Elder Care Author Doctor Marion Launches Second National Tour to Raise Awareness About Aging & Elder Care Issues in America
11. California State PTA Issues Statement Regarding Presidents Veto of SCHIP Legislation
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Issues New Warnings for Anemia Drugs
(Date:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media ... Pro X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice ... X users can now reveal the media of their split screens with growing ...
(Date:6/27/2016)... Overland Park, KS (PRWEB) , ... June 27, 2016 , ... ... leader in retailers of Eyeglasses . , Millions of individuals in the United ... life, eyeglasses have become a way to both correct vision and make a fashion ...
(Date:6/26/2016)... ... ... PawPaws brand pet supplements owned by Whole Health Supply is ... of felines. The formula is all-natural and is made from Chinese herbs that have ... Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root Extract ...
(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, ... -based mobile pulmonary function testing company, is now able to perform ... developed by ndd Medical Technologies , Inc. ... in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL ... can get any needed testing done in the comfort of her ...
(Date:6/24/2016)... KNOXVILLE, Tenn. , June 24, 2016 /PRNewswire/ ... market providing less invasive and more durable cerebrospinal ... million in funding.  The Series-A funding is led ... the Lighthouse Fund, and other private investors.  Arkis, ... less-invasive neurosurgical instrumentation and the market release of ...
(Date:6/23/2016)... , June 23, 2016  In a startling report released today, ... their residents by lacking a comprehensive, proven plan to eliminate prescription ... definitive ranking of how states are tackling the worst drug crisis ... four states – Kentucky , New ... Vermont . Of the 28 failing states, three – ...
Breaking Medicine Technology: