Erythropoiesis Stimulating Agents' Conditions Clarified
The FDA and Amgen have notified healthcare professionals about modifications to certain portions of the Boxed Warning section of prescription labeling for the erythropoiesis stimulating agents (ESAs) epoetin alfa (Procrit, Epogen), and darbepoetin alfa (Aranesp). These changes clarify the approved conditions for the use of these medications in patients with cancer, and revise the directions for dosing to state the hemoglobin level at which treatment with an ESA should be started.
Revisions will be made to the prescribing information stating that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure, and when to initiate and discontinue ESA dosing.
The FDA continues to encourage healthcare practitioners to discuss with their patients the benefits and risks of treatment with ESAs before starting or continuing therapy. These risks include thrombovascular events, increased risk of tumor progression or recurrence, and shortened survival time.
Alert for Patients Taking Mitoxantrone
The FDA issued an alert to healthcare practitioners about additional recommendations for cardiac monitoring of patients with multiple sclerosis (MS) who are treated with mitoxantrone (Novantrone). Postmarketing studies of the drug showed that there was poor adherence to labeling recommendations, stating that left ventricular ejection fraction (LVEF) should be evaluated before starting the treatment and before administering each dose of mitoxantrone to patients with MS. A recent safety study found that four patients developed heart failure 4 to 17 months after completing the mitoxantrone therapy.
Because of the potential severity of cardiotoxicity and evidence suggesting poor adherence to the recommendations for monitoring cardiac function, the FDA is working with the manufacturers of mitoxantrone to remind healthcare providers of the importance of following the labeling recommendations for patients with MS who are treated with mitoxantrone. The FDA and the manufacturers of mitoxantrone are also advising that all patients with MS who have finished treatment with mitoxantrone receive yearly quantitative LVEF evaluations to detect late-occurring cardiac toxicity.
FDA Approves I.V. Antihypertensive Clevidipine
The FDA has approved the marketing of clevidipine butyrate (Cleviprex) injectable emulsion for the reduction of BP when oral therapy is not feasible or desirable. Clevidipine butyrate is a product of The Medicines Company, and it is the first new I.V. drug for hypertension in 10 years.
Clevidipine butyrate is a calcium channel blocker that has a rapid onset and offset of action and can be titrated for precise BP control. Unlike many current I.V. antihypertensive agents, which are metabolized by the kidney or the liver, clevidipine butyrate is metabolized in the blood and tissues and does not accumulate in the body.
The approval of clevidipine butyrate was based on studies involving over 1,400 medical and surgical patients treated with the medication. All of the studies met their primary endpoints.
Clevidipine butyrate may produce systemic hypotension and reflex tachycardia. The most common adverse reactions seen with clevidipine butyrate are headache, nausea, and vomiting. Consult product labeling for specific prescribing directions and safety information.
Hyperkalemia Treatment Lots Recalled
Roxane Laboratories informed healthcare professionals of the recall of two lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL unit-dose bottles (NDC 0054-0165-51, lot 856396A Exp April 2010, and lot 856693A Exp May 2010). This product is used to treat hyperkalemia.
A sample from one of the affected lots tested positive for a strain of yeast that could potentially affect immunocompromised patients. Symptoms of a yeast infection range from thrush and skin rash to sepsis.