Pharmacy & Therapeutics - September 2008 - (Page 514)

NEW DRUGS related complications. The FDA changed all three strains for this year’s influenza vaccine. Two of the three strains recommended for the U.S. this year are now in use for the southern hemisphere’s 2008 influenza season. (Source: FDA, August 7, 2008.) DRUG NEWS Conference did not endorse it. However, findings from the Knee Arthroscopy Nadroparin Thromboprophylaxis Study Group suggest that prophylactic lowmolecular-weight heparin (LMWH) might be better than graduated compression stockings at reducing the incidence of thromboembolic events. The study, conducted in Italy, involved 1,761 patients who were randomly assigned to wear full-length graduated stockings for seven days or to receive a once-daily subcutaneous injection of LMWH for seven or 14 days. The threemonth cumulative incidence of asymptomatic proximal deep venous thrombosis, symptomatic venous thromboembolism, and all-cause mortality was 3.2% in the stockings group (21 of 660 patients) and 0.9% in both the seven-day LMWH group (6 of 657) and the 14-day group (4 of 444). The 14-day group stopped therapy prematurely because of concerns about a longer LMWH regimen. Although this is reportedly the largest randomized trial of venous thromboprophylaxis after knee arthroscopy, the researchers cite some caveats. They excluded patients who were undergoing prolonged procedures or who had risk factors for thromboembolism. Thus, the sample was low risk; nonetheless, they say that the 2.3-percentage point higher absolute incidence was statistically significant and was clinically important. They add that the graduated compression stockings were stronger than those commonly used; as a result, the benefit found for LMWH could be even greater. No patients withdrew from the study because of adverse events, and none of those in the LMWH groups experienced heparin-induced thrombocytopenia (HIT). The slightly higher incidence of clinically relevant non-major bleeding events observed in the seven-day LMWH group, compared with the graduated appropriate treatment and careful monitoring must be initiated until the patient recovers. Exenatide therapy should not be restarted. The FDA is collaborating with Amylin to add more prominent warnings in the product label. (Source: FDA, August 18, 2008.) Warning: Adverse Events with Simvastatin and Amiodarone The FDA has notified health care professionals of the risk of rhabdomyolysis (muscle injury), which can lead to kidney failure or death, when simvastatin (Zocor, Merck) is prescribed with amiodarone (Cordarone, Wyeth). This risk is dose-related and increases when more than 20 mg/day of simvastatin is given with amiodarone. The FDA has continued to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin even though a revision of the simvastatin label in 2002 described an increased risk of rhabdomyolysis in this circumstance. Health care providers should avoid prescribing doses of simvastatin above 20 mg/day in patients taking amiodarone. (Source: FDA, August 11, 2008.) Ezetimibe and Simvastatin (Vytorin): Linked to Cancer? The FDA is investigating a report of a possible association between the use of Vytorin (Merck/Schering-Plough) and a potentially increased incidence of cancer, as observed in the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) clinical trial. Vytorin is used to decrease the production of cholesterol by the liver and to inhibit the absorption of cholesterol in the intestine to reduce the risk of cardiovascular events. The trial tested whether lowering lowdensity lipoprotein (LDL) cholesterol with Vytorin would reduce the risk of cardiovascular events in individuals with aortic stenosis. Although a lower overall cardiovascular risk was not found with this drug, a larger percentage of subjects treated with Vytorin died from all types of cancer combined, when compared with patients receiving placebo during the five-year study. The FDA anticipates receiving a final SEAS study repor t in approximately three months, and its review of the clinical trial data and other relevant information should take six months. Physicians and caregivers should continue to monitor patients taking Vytorin and should report any side effects from the use of this drug to the FDA. (Source: FDA, August 25, 2008.) FDA Considers Stronger Labels For Exenatide (Byetta) Since issuing a letter to health care professionals in October 2007, the FDA has received repor ts of six cases of hemorrhagic or necrotizing pancreatitis in patients using exenatide (Byetta, Amylin/Lilly), which treats adults with type-2 diabetes. All six patients needed to be hospitalized; two patients died, and four patients were recovering. The drug was discontinued in all six cases. There are no signs or symptoms that distinguish acute hemorrhagic or necrotizing pancreatitis associated with exenatide from the less severe form of pancreatitis. If pancreatitis is confirmed, Heparins after Knee Surgery Most hospitals don’t routinely use thromboprophylaxis after knee arthroscopy, partly because the latest American College of Chest Physicians Consensus 514 P&T® • September 2008 • Vol. 33 No. 9

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

Pharmacy & Therapeutics - September 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Effect of Prescription Copays on Adherence and Treatment Failure with Oral Antidiabetic Medications Vaccine Declinations Present New Challenges for Public Health Universal Health Care in America Digestive Disease Week and American Diabetes Association Pharmaceutical Approval Update

Pharmacy & Therapeutics - September 2008

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