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

Posted 27 Jun 2011 by Drugs.com

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 showing increased risks of cardiovascular events with ESAs in this patient population. The new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke. BACKGROUND: ESAs treat certain types of anemia by stimulating the bone marrow to produce ... Read more

Related support groups: Aranesp, Epogen, Procrit, Darbepoetin Alfa, Epoetin Alfa

FDA Urges Reduced Doses for Anemia Drugs

Posted 25 Jun 2011 by Drugs.com

FRIDAY, June 24 – Doctors should use the anemia drugs Procrit, Epogen and Aranesp more cautiously in patients with chronic kidney disease, U.S. health officials said Friday. The new warning comes in response to data showing that patients on these drugs face a higher risk of cardiovascular problems such as heart attack, heart failure, stroke, blood clots and death, the U.S. Food and Drug Administration said. "FDA is recommending new, more conservative dosing recommendations for erythropoiesis-stimulating agents [ESAs] for patients with chronic kidney disease," Dr. Robert C. Kane, acting deputy director for safety in the division of hematology products, said during a news conference Friday. These recommendations are being added to the drug label's black box warning and sections of the package inserts, he said. This is not the first time health risks have been linked to these anemia ... Read more

Related support groups: Chronic Kidney Disease, Aranesp, Epogen, Procrit, Darbepoetin Alfa, Epoetin Alfa

Anemia Drug May Worsen Heart Attacks

Posted 10 May 2011 by Drugs.com

TUESDAY, May 10 – People given a drug known as erythropoietin alfa after a heart attack may experience new heart problems and even greater cardiac damage from the attack, a new study finds. The drug, which stimulates red blood cells, has been used in some heart attack patients because certain studies suggested it might reduce the extent of heart attack damage and improve heart function, the researchers explained. The study was published in the May 11 issue of the Journal of the American Medical Association. "This study shows that erythropoietin should only be used with caution in patients with recent heart attacks," said Dr. Deepak L. Bhatt, chief of cardiology at the VA Boston Healthcare System, who was not involved in the study. In fact, "there are hints in this study that the use of erythropoietin might have adverse cardiac effects," said Bhatt, who is also an associate professor of ... Read more

Related support groups: Epogen, Procrit, Epoetin Alfa

Use Anemia Drugs for Cancer Patients With Caution, Experts Say

Posted 26 Oct 2010 by Drugs.com

TUESDAY, Oct. 26 – Physicians need to use caution when giving a class of drugs called erythropoiesis-stimulating agents (ESAs) to cancer patients who have anemia caused by chemotherapy, according to new medical guidelines. And with rare exceptions, ESAs should not be given to cancer patients who are not receiving chemotherapy, according to joint guidelines issued by the American Society of Hematology and the American Society of Clinical Oncology. ESAs (marketed as Procrit, Epogen and Aranesp) stimulate the bone marrow to produce more red blood cells but are associated with shorter survival and increased risk of blood clots and tumor progression, the guidelines noted. However, ESAs reduce the need for red blood cell transfusions, which carry a risk of serious infection and adverse reactions in the immune system. The guidelines offer specific recommendations on the use of ESAs. Among ... Read more

FDA Advisers Back Anemia Drugs for Kidney Patients

Posted 19 Oct 2010 by Drugs.com

TUESDAY, Oct. 19 – Kidney-failure patients can continue taking a group of widely used anemia drugs, even though a recent study showed they can increase the risk of stroke, U.S. health advisers said Monday. A panel of U.S. Food and Drug Administration advisers voted 15-1, with one abstention, to maintain use of the drugs for patients with chronic kidney disease who aren't yet in need of dialysis, the Associated Press reported. The FDA is not required to follow the advice of its advisory panels, but typically does so. The drugs – Procrit, Aranesp and Epogen, a class of medications known as erythropoiesis-stimulating agents (ESAs) – boost oxygen-carrying red blood cells, reducing the need for painful blood transfusions. But sales have fallen sharply since 2007, when the FDA added the first of several safety warnings to the drugs, based on evidence they can cause tumor growth and hasten ... Read more

Related support groups: Chronic Kidney Disease, Aranesp, Epogen, Procrit

Anemia Drugs Could Pose Threat to Some Kidney Patients

Posted 15 Sep 2010 by Drugs.com

WEDNESDAY, Sept. 15 – When people with chronic kidney disease and type 2 diabetes take certain anemia drugs, the level of hemoglobin cells in their blood should go up. But a new study finds that if those levels don't increase by much, these "poor responders" experience a significantly increased risk of heart problems and death. Reporting in the Sept. 16 issue of the New England Journal of Medicine, a team of international researchers says that those who had the worst response to erythropoiesis-stimulating agents (ESAs) – drugs that include Aranesp, Epogen and Procrit – had a 31 percent rise in the risk of cardiovascular complications and a 41 percent increased risk of death. "For people who have chronic kidney disease, I think this is further evidence that we have to be extremely cautious when we use ESAs. There is a potential for harm. The patients who respond poorly are the ones ... Read more

Related support groups: Aranesp, Epogen, Procrit, Darbepoetin Alfa, Epoetin Alfa

Anemia Drugs Hold Dangers for Kidney Patients

Posted 5 May 2010 by Drugs.com

WEDNESDAY, May 5 – The powerful drugs used to fight anemia caused by kidney failure increase the risk for cardiovascular problems such as heart attack, a major study has found. A meta-analysis of 27 trials, which included more than 10,000 people who were given the drugs, known as erythropoiesis-stimulating agents (ESAs), found that those who took the drugs at the highest dosages had a 51 percent increased risk for stroke and a 33 percent increased risk for thrombosis, or blockage of an artery. The study, by an international group of experts, was published online May 3 in Annals of Internal Medicine. The increased risk for death (9 percent) and serious cardiovascular events such as heart attacks (15 percent) did not reach statistical significance, the analysis found. The U.S. Food and Drug Administration has acted to control the use of ESAs marketed as Epogen, Procrit and Aranesp, which ... Read more

For Some on Dialysis, Anemia Drugs Pose Risks

Posted 2 Mar 2010 by Drugs.com

TUESDAY, March 2 – Powerful drugs that treat the anemia caused by kidney failure yield mixed results, depending on the severity of the anemia, a new study has shown. People on dialysis with severe anemia, according to the study, tend to live longer when given high doses of the drugs – known as erythropoiesis-stimulating agents (ESAs) and marketed as Epogen, Procrit and Aranesp. But it found that the drugs increase the risk for dying prematurely among people with mild anemia. ESAs, which increase the production of red blood cells, are approved by the U.S. Food and Drug Administration to treat the anemia caused by cancer chemotherapy and AIDS drugs as well as kidney failure. But safety concerns have limited their use, especially among cancer patients. Over the next few months, the FDA and the U.S. Centers for Medicare and Medicaid Services plan to review the use of ESAs in the treatment ... Read more

FDA Tightens Controls on Anemia Drugs

Posted 16 Feb 2010 by Drugs.com

TUESDAY, Feb. 16 – 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 ... Read more

Related support groups: Aranesp, Epogen, Procrit

Anemia Drugs May Cause Deadly Blood Clots

Posted 1 Dec 2009 by Drugs.com

TUESDAY, Nov. 10 – New research on cancer patients adds to the controversy surrounding anemia drugs such as Procrit and Aranesp, concluding that they increase the risk of venous thromboembolism, potentially fatal blood clots. These drugs, called erythropoiesis-stimulating agents (ESAs), are commonly prescribed to fight anemia associated with chemotherapy and chronic kidney disease. Recent studies have linked them with increased risk of death, stroke and new cancers. "These drugs hit the market in the mid-1990s, and by 2002, 50 percent of patients on chemotherapy were receiving them," said lead researcher Dr. Dawn Hershman, co-director of the breast program at the Herbert Irving Comprehensive Cancer Center at New York-Presbyterian Hospital/Columbia University Medical Center in New York City. Initial testing of these drugs was done on only 12 weeks of use, she noted. "Right from the ... Read more

Related support groups: Aranesp, Epogen, Procrit, Darbepoetin Alfa, Epoetin Alfa

Anemia Drugs May Raise Death Risk in Cancer Patients

Posted 30 Apr 2009 by Drugs.com

THURSDAY, April 30 – Two new studies provide more evidence that drugs such as Procrit and Aranesp, often used by cancer patients to fight anemia-linked fatigue, may boost the risk of death and serious adverse events such as blood clots. These drugs, called erythropoiesis-stimulating agents (ESAs), have also been associated in prior studies with increased risk of heart attack, stroke and tumor growth. The primary argument for the continued use of these drugs is that they help reduce the number of blood transfusions some cancer patients need, while improving quality of life. However, a co-author of one paper, Dr. Anthony Reiman, from the University of Alberta, Canada, said his team is "supporting other groups that are recommending great caution in using these drugs for cancer patients, and in routine circumstances they may not be indicated. We hope the drugs would still be made available ... Read more

Related support groups: Aranesp, Epogen

FDA Medwatch Alert: Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

Posted 2 Dec 2008 by Drugs.com

[UPDATE 12/02/2008] FDA issued Q&As for recently approved Medication Guides. The Medication Guides were developed to provide patients with important information about the risks of using ESAs. The information in the Medication Guides may affect a patient’s decision to take the drug and it gives patients a starting point for discussion with their healthcare provider about the medical decision to prescribe an ESA.[UPDATE 08/08/2008] Amgen, Ortho Biotech letter added.[Posted 07/31/2008] FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment ... Read more

Related support groups: Aranesp, Epogen

Study Calls for Greater Scrutiny of 'Off-Label' Drug Use

Posted 24 Nov 2008 by Drugs.com

MONDAY, Nov. 24 – It's called "off-label" prescribing, and it's the common practice of doctors prescribing a drug to treat a disease or condition that's different from the one studied by federal regulators that led to the drug's approval in the first place. Despite the scope of the practice, there's often little evidence that using a drug for an unapproved purpose is always beneficial or safe, a new study found. The study by American researchers has identified 14 widely prescribed medications that they think need additional study to see how effective and safe they are for off-label use. Many of the drugs are antidepressants and antipsychotics. "Off-label prescribing is not based on the same level of evidence as on-label prescribing," said study lead researcher Surrey Walton, an assistant professor of pharmacy administration at the University of Illinois at Chicago. Most patients aren't ... Read more

Related support groups: Lexapro, Zoloft, Cymbalta, Wellbutrin, Seroquel, Coumadin, Celebrex, Singulair, Zyprexa, Risperdal, Zestril, Epogen, Procrit, Prinivil, Desyrel

Anemia Drugs Linked to Stroke Study Deaths: FDA

Posted 26 Sep 2008 by Drugs.com

FRIDAY, Sept. 26 – Preliminary results from a German study suggest that stroke patients' use of anti-anemia drugs such as Aranesp, Procrit and Epogen might end up boosting their risk for death, the U.S. Food and Drug Administration (FDA) warned on Friday. The goal of the study was to see if high doses of the anti-anemia drug epoetin alfa could improve the ability of stroke patients to take care of themselves after recovering from a stroke. The hope was that the drug would be neuroprotective, but use of epoetin alfa now appears linked to a near-doubling of mortality. This is not the first time that these drugs have come under scrutiny. In the United States, medications like Procrit were marketed heavily as anemia treatments, particularly for cancer patients and those with kidney failure. However, in July of this year, the FDA called on manufacturers of Aranesp and Procrit to add a ... Read more

Related support groups: Ischemic Stroke, Aranesp, Epogen, Procrit

FDA Medwatch Alert: Epoetin alfa

Posted 26 Sep 2008 by Drugs.com

Posted 09/23/2008] FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke. The clinical trial utilized doses of epoetin alfa that were considerably higher than the doses recommended for the treatment of anemia as described in the FDA-approved labeling for the product. Over a period of ninety days after the start of the trial, there were more deaths in the group of patients who received epoetin alfa compared to patients who received the placebo (16% versus 9%). Roughly half of all deaths in both groups occurred within the first seven days after starting the drug, with death from intracranial hemorrhage (bleeding within the brain) occurring among approximately 4% of patients who received epoetin alfa compared to 1% of patients in the placebo group.FDA anticipates the receipt of ... Read more

Related support groups: Epogen

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