Pharmacy & Therapeutics - March 2009 - (Page 125) NEW DRUGS patients with gout already are at a higher risk of heart disease, the FDA issued an approvable letter. Takeda resolved the safety question by performing a large new phase 3 clinical trial that enrolled more gout patients than the two previous phase 3 trials combined. The new study found no more deaths and no more heart problems in patients taking febuxostat than in patients taking allopurinol (e.g., Zyloprim, Alloprim). Based on those results, an FDA advisory committee recommended the approval of febuxostat in November 2008. Adverse events in clinical trials consisted of liver function abnormalities, nausea, joint pain, and rash. Sources: Takeda, February 14, 2009; WebMd, February 16, 2009 DRUG NEWS The vaccine is composed of three different strains to protect against the most common types of influenza viruses in a given year. The vaccines typically contain two A influenza strains (including an H1N1 subtype and an H3N2 subtype) and one B strain. For the 2009–2010 flu season, the FDA panel recommends that the A strains in the current influenza vaccine remain the same but that the B strain be changed because the number of flu cases attributed to that strain has increased in the U.S. The recommendation follows a similar statement made in Februar y by the World Health Organization for the Northern Hemisphere. Each year, the FDA must sign off on any strain changes and must approve influenza vaccines made by various companies for the upcoming influenza season. Source: The Wall Street Journal, February 18, 2009 • at least 44–65 pounds: darunavir 375 mg/ritonavir 50 mg twice daily • at least 66–87 pounds: darunavir 450 mg/ritonavir 60 mg twice daily • 88 pounds or more: dar unavir 600 mg/ritonavir 100 mg twice daily Sources: Medical News Today, February 12, 2009; www.prezista.com DRUG NEWS Safety Review for Xigris The FDA is working with Eli Lilly, the maker of drotrecogin alfa activated (Xigris), to learn more about the incidence of serious bleeding events and death in patients who received this drug. Xigris is used to treat severe sepsis. In a recent retrospective review of the medical records of 73 patients, serious bleeding events occurred in 35% of those patients who had a risk factor for bleeding and in 3.8% of patients without risk factors for bleeding. More patients with risk factors at baseline died (65%) compared with patients without any risk factors (24.5%). Xigris may increase the risk of bleeding, described in the prescribing information as the most common serious adverse effect. Xigris is not indicated if bleeding might lead to significant adverse reactions or death. The FDA is not recommending that practitioners stop prescribing Xigris. Consumers and health care professionals should notify the FDA of any complaints or problems associated with this product. Sources: Crit Care Med 2009;37(1): 19–25; FDA, February 4, 2009, www. fda. gov/cder/drug/early_comm/drotrecog in_alfa.html NEW FORMULATION Darunavir (Prezista) For Pediatric HIV Infection Tibotec Therapeutics/Centocor Ortho has announced the availability of a lowerdose (75-mg) formulation of darunavir (Prezista) for pediatric patients with HIV infection. These patients must range from 6 to 18 years of age and must weigh at least 44 pounds (20 kg). In 2006, approximately 56,500 young people between the ages of 13 and 24 years were living with HIV. In December 2008, the FDA approved darunavir, administered with ritonavir (Norvir, Abbott) and with other antiretroviral agents, for treating HIV infection in pediatric patients six years of age and older. In October 2008, darunavir was approved for treatment-naive and treatment-experienced adults as part of combination therapy. The tablets are taken with food. The dosage, based on body weight, should not exceed the recommended treatmentexperienced adult dose. Pediatric dosing is as follows: Adding Cetuximab (Erbitux) Might Not Improve Colon Cancer In a study from The Netherlands, researchers noted that mixing cocktails of drugs to fight cancer did not always succeed. Adding cetuximab (Erbitux, ImClone/Bristol-Myers Squibb/Eli Lilly) to an already-potent drug combination offered no extra benefit against advanced colon cancer. In fact, patients fared worse when cetuximab was added to three anticancer drugs: capecitabine (Xeloda, Roche), oxaliplatin (Eloxatin, SanofiAventis), and bevacizumab (Avastin, Genentech/Roche). For volunteers who did not take cetuximab, their tumors remained stable for more than a month longer than the patients who did receive this agent. The non-cetuximab participants also reported a higher quality of life. The findings might have resulted from a negative interaction between cetux- Change in Flu Vaccine Urged The FDA is proposing that one strain in next season’s influenza vaccine be changed so that the vaccine will be an appropriate match against the virus. Vol. 34 No. 3 • March 2009 • P&T® 125 http://www.prezista.com http://www.fda.gov/cder/drug/early_comm/drotrecogin_alfa.html http://www.fda.gov/cder/drug/early_comm/drotrecogin_alfa.html http://www.fda.gov/cder/drug/early_comm/drotrecogin_alfa.html
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