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

Posted 10 May 2017 by Drugs.com

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 a drug withdrawal, but more commonly a black-box warning or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined," said study leader Dr. Joseph Ross. He is an associate professor of medicine and public health at Yale University. Of 222 drugs approved by the agency during the study period, three were withdrawn, 61 received boxed warnings and 59 prompted safety communications, the findings showed. Drugs most likely to have ... Read more

Related support groups: Seroquel, Abilify, Latuda, Risperidone, Zyprexa, Risperdal, Quetiapine, Geodon, Saphris, Seroquel XR, Olanzapine, Invega, Rexulti, Clozapine, Aripiprazole, Arginine, Clozaril, L-Arginine, Ziprasidone, Vraylar

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

Posted 16 Feb 2016 by Drugs.com

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 Aranesp. Patients may still benefit from the medications because they reduce the need for blood transfusions to treat severe anemia, said Dr. Navdeep Tangri, senior researcher on the study. "But this should close the book on the idea that these drugs help with exhaustion and improve patients' quality of life," said Tangri, an attending doctor at Seven Oaks General Hospital Renal Program in Manitoba, Canada. However, one expert argued that while on average, that is true, some patients do feel ... Read more

Related support groups: Anemia, Renal Failure, Chronic Kidney Disease, Peritoneal dialysis, Aranesp, Procrit, Epogen, Renal Osteodystrophy, Darbepoetin Alfa, Mircera, Epoetin Beta-Methoxy Polyethylene Glycol, Anemia Associated with Chronic Disease, Peginesatide, Hyperphosphatemia of Renal Failure, Epoetin Alfa, Omontys

FDA Medwatch Alert: Omontys (peginesatide) Injection by Affymax and Takeda: Recall of All Lots - Serious Hypersensitivity Reactions

Posted 25 Feb 2013 by Drugs.com

ISSUE: Affymax, Inc. and Takeda Pharmaceutical Company Limited along with the U.S. Food and Drug Administration (FDA) are informing the public of a voluntary recall of all lots of OMONTYS® (peginesatide) Injection to the user level as a result of new postmarketing reports regarding serious hypersensitivity reactions, including anaphylaxis, which can be life-threatening or fatal. To date, fatal reactions have been reported in approximately 0.02% of patients following the first dose of intravenous administration. The reported serious hypersensitivity reactions have occurred within 30 minutes after such administration of Omontys. There have been no reports of such reactions following subsequent dosing, or in patients who have completed their dialysis session. Since launch, more than 25,000 patients have received Omontys in the postmarketing setting.  The rate of overall hypersensitivity re ... Read more

Related support groups: Peginesatide, Omontys

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Anemia Associated with Chronic Renal Failure

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Omontys

Peginesatide Patient Information at Drugs.com