1. Aschenbrenner, Diane S. MS, APRN, BC

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The U.S. Food and Drug Administration (FDA) has requested that changes be made to warnings on the labels of drugs in two classes.


First, as the result of case reports submitted to the FDA's MedWatch program, the packaging of all sedative-hypnotic drugs now must warn about the possibility of anaphylaxis and angioedema occurring as early as with the first dose. The labeling must also warn that patients may engage in activities while asleep, such as driving, preparing and eating food, and making telephone calls, and then not recall the activity upon awakening. The FDA has also directed the manufacturers to develop a patient medication guide that will be dispensed with each prescription to advise consumers of the drugs' possible adverse effects. The drugs involved include Ambien and Ambien CR (zolpidem), Butisol (butabarbital), Carbrital (pentobarbital and carbromal), Dalmane (flurazepam), Doral (quazepam), Halcion (triazolam), Lunesta (eszopiclone), Placidyl (ethchlorvynol), ProSom (estazolam), Restoril (temazepam), Rozerem (ramelteon), Seconal (secobarbital), and Sonata (zaleplon). The FDA does not state whether case reports involving each of the drugs were received.


The labeling of the erythropoietic agents epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp), which stimulate the production of red blood cells, must be updated with stronger warnings and modified dosing instructions advising against administering doses higher than recommended. This class of drugs has recently been associated with serious, life-threatening, and possibly fatal cardiovascular, arterial, and venous thromboembolic events.


Labels will now advise that, to lower the risk of death and serious cardiovascular events, the lowest dose that prevents the need for blood transfusion but does not raise the hemoglobin level above 12 g/dL should be used. Labels will also state that, when erythropoiesis-stimulating agents were used to achieve a target hemoglobin level of higher than 12 g/dL, patients with advanced head and neck cancer being treated with radiation therapy had shorter times to tumor progression, patients with metastatic breast cancer being treated with chemotherapy had disease progression with shorter overall survival and increased risk of death, and cancer patients with active malignant disease not being treated with chemotherapy or radiation therapy had an increased risk of death; this last population should not be given these drugs at all. Another black box warning will note that there was a greater incidence of deep venous thrombosis in patients treated with epoetin alfa at the approved dose before surgery to minimize the need for transfusion of red blood cells.


Nurses should be aware that close monitoring of the hemoglobin level is necessary in patients receiving epoetin alfa or darbepoetin alfa. Hemoglobin should be measured twice weekly after treatment begins and after any dosage change until it has stabilized. If the hemoglobin level rises above 12 g/dL or increases by 1g/dL or more in any two-week period, the next dose of the erythropoiesis-stimulating agent should be withheld and the physician consulted.


U.S. Food and Drug Administration. FDA news: FDA requests label change for all sleep disorder drug products. 2007 Mar 14.;


U.S. Food and Drug Administration. FDA information for healthcare professions: erythropoiesis stimulating agents (ESA). 2007 Mar 9.;


U.S. Food and Drug Administration. FDA news: FDA strengthens safety information for erythropoiesis-stimulating agents (ESAs). 2007 Mar 9.