Pharmacy & Therapeutics - November 2008 - (Page 628)

NEW DRUGS 800 mg (two 400-mg tablets) with ritonavir 100 mg once daily. For treatmentexperienced adults, the dose remains 600 mg taken with ritonavir 100 mg twice daily. Darunavir must be taken with food and with other antiretroviral agents. Tibotec will stop making the 300-mg tablet as a result of decreasing demand following the introduction of the 600-mg tablet earlier this year. (Source: Johnson & Johnson, October 21, 2008.) DRUG NEWS warning letters, alerts, recalls, regulations, safe use and disposal of medications, how to report problems through MedWatch, consumer articles on drug safety, and the FDA’s response to the Institute of Medicine’s 2006 report on the future of drug safety. Establishing a Web page of this type was one of the requirements of the Food and Drug Administration Amendments Act of 2007. (Source: FDA, October 15, 2008.) May. Shipments to wholesalers began on September 30, 2008. (Source: Enhanced Online News, October 9, 2008, http://eon.businesswire. com.) Updated Labeling for Psoriasis Agent Efalizumab (Raptiva) The FDA has announced new labeling and a boxed warning to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Genentech’s efalizumab (Raptiva). The FDA is also requiring the the company to submit a Risk Evaluation and Mitigation Strategy, which will include a patient medication guide. The FDA has received reports of serious infections leading to hospitalizations and deaths in patients using efalizumab. This once-weekly injection is indicated for adults with moderate-to-severe plaque psoriasis who are candidates for wholebody therapy or phototherapy. The boxed warning highlights the risk of bacterial sepsis, viral meningitis, invasive fungal disease, PML, and other opportunistic infections. The updated label also includes data from juvenile animal studies in mice. Efalizumab suppresses the immune system to reduce psoriasis flare-ups; however, by suppressing the body’s natural defenses, it can also increase the risk of infections and malignancies. This agent is not approved for children younger than 18 years of age. (Source: FDA, October 17, 2008.) NEW FORMULATION Premixed Conivaptan (Vaprisol) for Hyponatremia Astellas Pharma US has announced the FDA’s approval of a new premixed formulation of conivaptan HCl injection (Vaprisol) Premixed in 5% Dextrose. This arginine vasopressin receptor antagonist is indicated for treating both euvolemic and hyper volemic hyponatremia in hospitalized patients. Hyponatremia occurs when the body’s blood sodium level falls significantly below normal and may result from elevated levels of the hormone arginine vasopressin (AVP), which regulates water and salt balance in the body. Conavaptan blocks the activity of AVP, resulting in increased urine output without loss of electrolytes such as sodium and potassium. It was originally approved as an ampule. With the new 100-mL, single-use premixed formulation, no measuring or mixing is required. The expiration date is 24 months, six months longer than that of the ampule form. (Sources: Astellas Pharma US, October 22, 2008, www.vaprisol.com.) Too Much Heparin After Heart Attacks Approximately 50% of patients with STsegment elevation myocardial infarction (STEMI) who are treated with heparin and fibrinolytic agents have received an excess dose of unfractionated heparin (UFH), according to researchers from Duke University and the University of Cincinnati. Of 964 patients treated with fibrinolytic agents, 758 (79%) received adjunctive UFH therapy. Guidelines recommend a maximum bolus dose of 4,000 units and a maximum infusion dose of 1,000 units/ hour, but 336 patients (44%) received excess bolus doses and 129 patients (17%) received excess infusion doses. Among patients receiving excess dosing, more than one-third (137) received bolus or infusion doses far above recommended levels. An excess dose was defined as more than a 60-unit/kg bolus or more than a 12-unit/kg-per-hour infusion; major excess was defined as a bolus dose above 70 units/kg or an infusion of above 15 units/kg per hour. Women, older patients, and thinner patients were more likely to receive excess dosing. Proper dosing of fibrinolytic and antithrombotic drugs is crucial for patients with STEMI, because these patients are already at a higher risk of bleeding. It was not clear whether the “one-dosefits-all” method was related to the underrecognition of dosing guidelines or was DRUG NEWS Venlafaxine ER Tablets Now Available Venlafaxine Extended-Release Tablets (Osmotica Pharmaceuticals), at doses of 37.5 mg, 75 mg, 150 mg, and 225 mg, are now available. The drug was approved in FDA Drug Safety Web Page Consumers and health care professionals can now go to a single page on the FDA’s Web site (www.fda.gov/cder/ drugSafety.htm). The site provides links to topics such as drug labeling, postmarketing studies, benefits and risks of agents, clinical trials, quarterly reports, 628 P&T® • November 2008 • Vol. 33 No. 11 http://eon.businesswire.com http://eon.businesswire.com http://www.vaprisol.com http://www.fda.gov/cder/drugSafety.htm http://www.fda.gov/cder/drugSafety.htm

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - November 2008

Pharmacy & Therapeutics - November 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Heparin-Induced Thrombocytopenia Medication Utilization Patterns and Hypertension-Related Expenditures among Patients Who Were Switched From Fixed-Dose to Free-Combination Antihypertensive Therapy European Society for Medical Oncology and Association for the Study of Bone and Mineral Research Pharmaceutical Approval Update

Pharmacy & Therapeutics - November 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.