Navigation Links
FDA Tightens Controls on Anemia Drugs
Date:2/16/2010

Procrit, similar medicines have been tied to strokes, tumor progression in cancer patients, agency says

TUESDAY, Feb. 16 (HealthDay News) -- U.S. federal health authorities on Tuesday rolled out a new safety plan for the use of Procrit and similar anemia drugs by people with cancer.

These medicines -- often used by cancer patients to lower the need for blood transfusions and improve quality of life -- have been tied to stroke, heart failure, tumor promotion and death in recent studies.

"The plan requires the drug manufacturer to implement a program to ensure that health-care professionals understand the appropriate use of these drugs and adequately inform patients of the drugs' risks," said Dr. Richard Pazdur, director of the Office of Oncology Drug Products at the Center for Drug Evaluation and Research (CDER), part of the U.S. Food and Drug Administration (FDA), at an afternoon news conference.

Procrit is one of three so-called erythropoiesis-stimulating agents (ESAs) manufactured by Amgen (the other two are Epogen and Aranesp), all of which are covered under the new plan. All three drugs are FDA-approved for people battling cancer, those infected with HIV, people with kidney failure and certain patients undergoing surgery, and all three carry with them an elevated risk of blood clots, stroke, heart failure, tumor promotion and death.

The new rules do not apply to indications other than use by cancer patients.

"Amgen will ensure that only certified health-care professionals may dispense and prescribe ESAs to patients with cancer and that all certified prescribers are trained to understand and communicate to patients the increased risk of tumor growth that these drugs present to patients with cancer," Pazdur said.

"The risks for cancer patients are much different," he added. Nor are the risks equal for all cancer patients, with the agency making a distinction between patients being treated with an aim to a cure and those receiving only palliative care.

Specifically, the plan requires that Amgen develop and disseminate a medication guide informing all cancer patients of the drugs' risks and that doctors not only discuss the risks with patients but also obtain patients' signatures.

Amgen is also obligated to ensure that all health-care providers prescribing and dispensing ESAs be trained and certified, and maintain active enrollment in the APPRISE (Assisting Providers and Cancer Patients with Risk Information for the Safe Use of ESAs) program. Providers not enrolled in the program will not be able to prescribe ESAs to cancer patients and they must re-enroll every three years, Pazdur said.

Amgen will be required to provide progress reports on the program, which will then be reviewed by the FDA, said Dr. Patricia Keegan, director of CDER's Division of Biologic Oncology Products.

"We understand that the requirements of the safe use program will create new responsibilities for busy health-care providers and will require additional time for training, record keeping and other tasks, but we are not doing this to make things more difficult for health-care providers," Pazdur said. "We are doing this to make absolutely certain that patients are fully informed related to the use of these drugs before they begin treatment."

The new rules take effect in March, although providers will have a year to come up to speed.

These heavily promoted medicines have come under fire before. In 2007, the FDA added a black box warning to the drugs, which has been "updated several times as new studies and new information has been made available," Keegan said. The FDA also recommended that the medications be prescribed at the lowest doses possible because trials generally indicated an increased risk when blood levels were raised above 12 grams per deciliter.

More information

View today's safety announcement at the U.S. FDA Web site.



SOURCES: Feb. 16, 2010 teleconference with Richard Pazdur, M.D., director, Office of Oncology Drug Products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), and Patricia Keegan, M.D., director, Division of Biologic Oncology Products, CDER, FDA


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Acupuncturists Relocation Tightens Relationship With Fertility Clinic
2. USCIS Tightens Vaccination Requirements
3. Sterling Life Enhances Marketing Operations Controls to Better Serve Medicare Beneficiaries
4. Scientists uncover how the brain controls what the eyes see
5. Protein that controls hair growth also keeps stem cells slumbering
6. Notch controls bone formation and strength
7. China Nepstar Chain Drugstore to Implement SAP ERP Solution to Optimize Management and Cost Controls and Enhance Operating Efficiencies
8. Protein in Human Embryonic Stem Cells Controls Malignant Tumor Cells
9. Georgetown researchers find stem cell marker controls 2 key cancer pathways
10. Stem Cell Marker Controls Pair of Key Cancer Pathways
11. Monkey Controls Robotic Arm With Brain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... Registered nurses, ... free CEU seminar titled, “Stroke Management: Time to Act, Time to Heal” on Thursday, ... in Whippany, N.J. The presenter is Vishal Chedda, president of ANSA Consultants, who ...
(Date:2/11/2016)... ... February 12, 2016 , ... The Journal of Pain ... 0.416 in 2013. The SJR uses data taken from the Scopus database (Elsevier B.V.) ... number of citations received by the journal over a three year period and also ...
(Date:2/11/2016)... IL (PRWEB) , ... February 11, 2016 , ... ... to the healthcare industry, ranked among the top five firms in the “2015/2016 ... and HIT Implementation Support and Staffing. KLAS is a research and insights firm ...
(Date:2/11/2016)... ... 11, 2016 , ... Thermi™, a world leader in thermistor-regulated ... the promotions of Allison Kelly to executive vice president of the company’s new ... of North American capital sales, and Wendy Oseas to vice president of global ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... ... an unparalleled clinical decision support technology, with highly adaptable algorithms, has been updated ... a patient has signs and symptoms consistent with Zikas and a travel history ...
Breaking Medicine News(10 mins):
(Date:2/11/2016)... Potrero Medical, Inc., the developer of the Accuryn™ critical care ... George M. Rapier, III , MD, to its Board of ... is one of the nation,s largest physician owned practice management ... Texas and Florida . ... medicine practice, he has been instrumental to the company,s growth ...
(Date:2/11/2016)... , Feb. 11, 2016  AfterPill.com is reporting that ... alcohol abstinence for all women who are at risk ... U.S. each year and raises the risks of unprotected ... --> According to the Guttmacher Institute, there ... women of child-bearing age, who have sex without the ...
(Date:2/11/2016)... -- Proliant Biologicals is proud to announce the opening of ... The facility is located on the North Island of ... Boone , Iowa.  The equipment design ... in the U.S. facility, with critical processing systems coming ... --> Boone , Iowa.  The ...
Breaking Medicine Technology: