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Procrit News

'BioSimilar' Drug Retacrit (Epoetin Alfa-epbx) Approved to Treat Certain Types of Anemia

Posted 15 May 2018 by

TUESDAY, May 15, 2018 – Retacrit (epoetin alfa-epbx) has been approved by the U.S. Food and Drug Administration as the first "biosimilar" to the anemia drugs Epogen and Procrit. A biosimilar, derived from a living organism, has been proven to be "highly similar" to a product that's already been approved by the FDA. It's also been shown to have no "clinically meaningful differences" in its ...

Nearly a Third of Drugs Hit by Safety Issues After FDA Approval

Posted 10 May 2017 by

WEDNESDAY, May 10, 2017 – Safety problems emerge with nearly one in three prescription drugs after they've been approved by the U.S. Food and Drug Administration, a new study reveals. Researchers examined data on drugs approved by the FDA between 2001 and 2010, with follow-up through 2017. The investigators found that 32 percent of the drugs had safety issues after approval. "That is very rarely ...

Anemia Drugs May Not Boost Kidney Patients' Well-Being: Study

Posted 16 Feb 2016 by

MONDAY, Feb. 15, 2016 – The pricey anemia drugs often given to people with chronic kidney disease may make no difference in how they feel day to day, a new research review confirms. Researchers said the study results back up current guidelines on how to use the drugs, called erythropoietin-stimulating agents (ESAs). These include the injection drugs marketed under the names Procrit, Epogen and ...

Anemia Treatments Don't Boost Recovery From Brain Injury, Study Finds

Posted 1 Jul 2014 by

TUESDAY, July 1, 2014 – People who suffer a severe head injury often develop anemia, but aggressively treating the blood condition may do more harm than good, a new clinical trial suggests. Experts said the findings, reported July 2 in the Journal of the American Medical Association, were disappointing: Treating anemia with blood transfusions – and in some cases, the medication erythropoietin ...

FDA Medwatch Alert: Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations

Posted 27 Jun 2011 by

Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp) ISSUE: FDA notified healthcare professionals that new, modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) have been approved to improve the safe use of these drugs. FDA has made these recommendations because of data ...

FDA Medwatch Alert: Procrit (epoetin alfa) - Mar 19, 2007

Posted 9 Mar 2007 by

[UPDATE 03/09/2007] FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). Four new studies in patients with cancer found a higher chance of serious and life-threatening side effects or death with the use of ESAs. These research studies were evaluating an unapproved ...

FDA Medwatch Alert: Procrit (epoetin alfa) - Dec 1, 2005

Posted 1 Dec 2005 by

[Posted 12/01/2005] Amgen, Ortho Biotech and FDA notified healthcare professionals of revision to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Epogen and Procrit. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with ...

FDA Medwatch Alert: Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)

Posted 12 Mar 2008 by

[Posted 03/12/2008] Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results ...

FDA Medwatch Alert: Erythropoiesis Stimulating Agents:Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)

Posted 8 Nov 2007 by

[Posted 11/08/2007] FDA notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen, and Procrit pose to patients with cancer and patients with chronic kidney failure. For patients with cancer, ...

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Related Condition Support Groups

Anemia Associated with Chronic Renal Failure, Anemia, Anemia - Chemotherapy Induced, Anemia Prior to Surgery, Anemia - Drug Induced

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