Drug Topics - February 25, 2008 - (Page 8)

8 DRUG TOPICS FEBRUARY 25, 2008 www.drugtopics.com > > > NEWS Roundup Rx Care Green light given to generic Fosamax The FDA has approved the first generic forms of alendronate sodium, formally only available as brand-name Fosamax (Merck), for the treatment of osteoporosis. Teva Pharmaceuticals USA will commence manufacture of alendronate sodium tablets in 5-mg, 10-mg, and 40mg dosages for once-daily administration, and 35-mg and 70-mg strengths for once-weekly use. In addition, Barr Laboratories was granted permission to market the 70-mg once-weekly alendronate tablet. ENDORSE study shows prevention lacking for VTE Results of the Epidemiologic International Day for the Evaluation of Patients at Risk for Venous Thromboembolism in the Acute Hospital Care Setting (ENDORSE) study show that 64% of hospitalized surgical and 42% of hospitalized medical patients were at risk for venous thromboembolism (VTE). Of those at risk, ENDORSE revealed that only 59% of surgical patients and 40% of the medical patients were treated prophylactically for VTE. According to investigators, the problem will require both local and national education programs, guideline development, increased reimbursement for prophylaxis, and the addition of VTE prevention to the healthcare agenda in every country in order to improve prevention levels. ENDORSE looked at more than 60,000 patients from 358 different hospitals in 32 countries. The researchers followed consensus guidelines from the American College of Chest Physicians (ACCP) during the study, which was funded by an unrestricted grant from sanofi-aventis. Asmanex OKed for younger asthmatics The Asmanex Twisthaler, from Schering-Plough, is now approved for the maintenance treatment of asthma as a preventative therapy in patients ages four to 11 years old. Containing mometasone furoate inhalation powder, the new inhaler was previously approved as a preventative therapy for asthma in patients 12 years of age and older, but in 220 mcg per actuation strength. The newly approved strength is 110 mcg per actuation, which is typically administered once daily in the evening. SynchroMed EL Implantable Infusion Pump models recalled FDA has issued a Class I recall of Medtronic Inc., SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient’s symptoms, and/or symptoms of drug underinfusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer. Read the complete 2008 MedWatch Safety Summary including a link to the FDA Call I Recall Notice at www.fda.gov/medwatch/safety/2008/safety08.htm# SynchroMed. FDA pulls unapproved colchicine from shelves In the seventh enforcement action taken by the FDA so far against unapproved drugs since it published its Compliance Policy Guide in 2006, the agency has now taken aim at injectable colchicine. The FDA said there have been 50 adverse event reports related to use of the drug, including 23 deaths. Typically used to treat gout, the drug has a narrow therapeutic margin, with potential fatal effects, including low blood cell counts, cardiac events, and organ failure. Manufacturers will have 30 days to cease production and 180 days to stop shipping the drug. According to the FDA, there are currently no colchicine products on the market that have undergone agency review and approval, including oral versions of the drug. The latest action will not affect colchicine oral tablets however, due to their wider margin of safety, but could be subject to FDA enforcement at any time, the agency said. The crackdown on unapproved drugs began in June 2006 when the FDA published a Compliance Policy Guide in an effort to ensure that all products marketed in the United States have undergone the approval process and met various safety, efficacy, and manufacturing standards. More information can be accessed at www.fda.gov/cder/ drug/unapproved_drugs/colchicine_qa.htm. FDA lights fire under smokingcessation drug Chantix After sending out an Early Communication in November 2007 regarding reports of suicidality in patients taking varenicline (Chantix, Pfizer), the Food & Drug Administration now says there is reason to Photo: Jim Shive http://www.drugtopics.com http://www.fda.gov/medwatch/safety/2008/safety08.htm#SynchroMed http://www.fda.gov/medwatch/safety/2008/safety08.htm#SynchroMed http://www.fda.gov/cder/drug/unapproved_drugs/colchicine_qa.htm http://www.fda.gov/cder/drug/unapproved_drugs/colchicine_qa.htm

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Contents Top 200 OTCs/HBCs in 2007 Clinical Pharmacists Advance into All Areas of Medical Treatment New Products Latest News Roundup

Drug Topics - February 25, 2008

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