The U.S. Food and Drug Administration (FDA) has issued new warnings for anemia drugs for patients with kidney disease after studies suggested such drugs could increase stroke risks. The new warnings are the latest to hit the widely used medications since 2007, when the FDA first said they could cause fatal side effects.
The drugs in question belong to the class of agents that stimulate erythropoiesis or making of new red blood cells. They are used to treat anemia caused by chronic kidney disease. A study published in 2009 suggested they could double the risk of stroke. It was seen in some other clinical trials that use of the agents increased risk of death, serious adverse cardiovascular reactions and stroke.
Amgen Inc. (AMGN) said two of its treatments will feature the updated warning labels, which tell doctors to reduce or interrupt doses of its Aranesp and Epogen drugs when patients' hemoglobin levels approach certain levels. The new warnings also add specific instructions for patients on dialysis, though the study used patients who weren't on dialysis. Johnson & Johnson (JNJ) unit Janssen Products LP also said it will update warnings on its drug Procrit.
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