Pharmacy & Therapeutics - March 2008 - (Page 132) NEW DRUGS NEW FORMULATION Fosaprepitant (Emend) Injection to Prevent Nausea From Chemotherapy Fosaprepitant dimeglumine (Emend for Injection), Merck’s new intravenous (IV) therapy for preventing chemotherapy-induced nausea and vomiting, is now approved. This is the IV prodrug of oral aprepitant (Emend). When the injection is administered, fosaprepitant is rapidly converted in the body to aprepitant. An injected dose of 115 mg may be substituted for 125 mg of the oral capsule on the first day. It is given 30 minutes before chemotherapy begins, over a 15minute period. During the three-day regimen, patients receive the injection (115 mg) or Emend (125 mg orally) on the first day; oral Emend 80 mg on the second and third days; and a corticosteroid and a 5-HT3 (serotonin) antagonist. (Source: Merck, January 29, 2008.) DRUG NEWS Schering-Plough) plus Merck’s simvastatin (Zocor). A study in January suggested that Vytorin did not reduce the buildup of plaque in arteries any better than the less expensive Zocor alone. (Source: Bloomberg News, February 15, 2008.) Alerts and Warnings Antiepileptic Drugs And Suicidal Thoughts The FDA has issued an alert about an increased risk of suicidal thoughts and behaviors in patients taking antiepileptic agents to treat seizures, bipolar disorder, migraine headaches, and other con ditions. Patients taking anti epileptic drugs had about twice the risk of suicidal thoughts and behaviors compared with those receiving placebo. The FDA reviewed data from 199 placebo-controlled studies of 11 drugs: carbamazepine (Carbatrol, Tegretol); felbamate (Felbatol); gaba pentin (Neurontin); lamotrigine (Lamictal); levetiracetam (Keppra); oxcarbazepine (Trileptal); pregabalin (Lyrica); tiagabine (Gabitril); topiramate (Topamax); valproate (Depakote, Depakene, Depacon); and zonisamide (Zonegran). The FDA expects that labeling changes will be applied to the entire drug class. (Source: FDA, February 4, 2008.) NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name Mitroflow Aortic Pericardial Heart Valve Manufacturer: CarboMedics, Inc., Austin, Tex. Approval Date: October 23, 2007 Use Classification: The valve replaces diseased, damaged, or malfunctioning native or prosthetic aortic valves. Description: A single piece of bovine pericardium is preserved with glutaraldehyde and sewn onto a polyestercovered polymer stent. A radiopaque silicone sewing ring is attached to the outer perimeter of the inflow side of the valve. The valve is available in aortic diameter sizes of 19, 21, 23, 25, and 27 mm. Purpose: The device replaces the function of a human heart valve; it opens and closes under the forces that arise during the natural beating of the heart. Benefit: Patients with a diseased aortic heart valve may feel weak or otherwise handicapped. Surgical replacement of the affected valve may improve the patient’s health and quality of life. Sources: www.mitroflow.com; www. fda.gov; carbomedics.com Name: Epicel Cultured Epidermal Autograft Manufacturer: Genzyme Biosurgery, Cambridge, Mass. Approval Date: October 25, 2007 Use Classification: Epicel is indicated to treat deep dermal or full-thickness burns covering a total body surface area of 30% of more. This skin graft (autograft) may be used with split-thickness DRUG NEWS Recall: Fentanyl (Duragesic) Pain Patch Johnson & Johnson’s Duragesic Pain Patch has been recalled because of a potential for a manufacturing flaw to cause accidental overdoses. This patch is indicated for persistent, moderate-tosevere chronic pain in opioid-tolerant patients two years of age or older. Fentanyl is most often used for cancer pain. The recall includes all 25-mcg/hour patches sold in the U.S. by J&J’s PriCara unit with an expiration date of December 2009 or before. This is the fifth recall of some version of the patch since 1994. In Januar y, J&J received returned patches that had cut edges. The defect can result in leaking of the fentanyl gel. Direct exposure to fentanyl can cause breathing problems and potentially fatal overdoses. (Sources: Washington Post and Bloomberg News, February 13 and 14, 2008.) Varenicline (Chantix) And Psychiatric Symptoms A public health advisor y has been issued for varenicline (Chantix, Pfizer), which is used to help patients stop smoking, because of an association with serious neuropsychiatric symptoms. The FDA has asked Pfizer to elevate the prominence of this safety information to the warnings and precautions sections of the prescribing information. The FDA is also working with the company to complete a medication guide for patients. Varenicline was approved in May 2006. (Source: FDA, February 4, 2008.) Depression and Cholesterol Drugs Depression will be added to the list of possible adverse effects in the prescribing information for the cholesterollowering drugs Vytorin and Zetia. Vytorin is a combination of ezetimibe (Zetia, 132 P&T® • March 2008 • Vol. 33 No. 3 http://www.mitroflow.com http://www.fda.gov http://www.fda.gov http://www.carbomedics.com/professional.asp
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