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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 ...

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 Urges Reduced Doses for Anemia Drugs

Posted 25 Jun 2011 by

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 ...

Use Anemia Drugs for Cancer Patients With Caution, Experts Say

Posted 26 Oct 2010 by

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 ...

FDA Advisers Back Anemia Drugs for Kidney Patients

Posted 19 Oct 2010 by

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, ...

Anemia Drugs Could Pose Threat to Some Kidney Patients

Posted 15 Sep 2010 by

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 ...

Anemia Drugs Hold Dangers for Kidney Patients

Posted 5 May 2010 by

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 ...

For Some on Dialysis, Anemia Drugs Pose Risks

Posted 2 Mar 2010 by

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 ...

FDA Tightens Controls on Anemia Drugs

Posted 16 Feb 2010 by

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 ...

Anemia Drug May Raise Stroke Risk in Kidney Patients

Posted 1 Dec 2009 by

SATURDAY, Oct. 31 – A drug designed to fight anemia appears to double the risk of stroke in patients with diabetes and kidney disease without substantially improving their quality of life, a new study finds. Darbepoetin alfa, marketed as Aranesp and known as an erythropoiesis-stimulating agent (ESA), is often prescribed for diabetic patients with chronic kidney disease and mild anemia. "The ...

Anemia Drugs May Cause Deadly Blood Clots

Posted 1 Dec 2009 by

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 ...

FDA Medwatch Alert: Aranesp (darbepoetin alfa) - Mar 9, 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: Aranesp (darbepoetin alfa) - Jan 27, 2007

Posted 27 Jan 2007 by

[Posted 01/27/2007] Amgen notified the oncology medical community of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy. The study also showed higher mortality in patients receiving Aranesp. Aranesp is ...

FDA Medwatch Alert: Aranesp (darbepoetin alfa) - Jan 14, 2005

Posted 14 Jan 2005 by

FDA and Amgen notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Aranesp, indicated for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. This safety information alerts physicians to the adverse effects observed with other products in this class in association with off-label dosing ...

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Anemia Associated with Chronic Renal Failure, Anemia - Chemotherapy Induced

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