New drug helps prevent blood clots after hip, knee surgery. (NH News Notes).A new drug, fondaparinux sodium fondaparinux sodium Arixtra Pharmacologic class: Selective factor Xa inhibitor Therapeutic class: Anticoagulant, antithrombotic Pregnancy risk category B FDA Boxed Warning2.5 mg injection (Arixtra[R]) from Organon or·ga·non or or·ga·numn. pl. or·ga·nons or or·ga·nums or or·ga·na 1. An organ. 2. A set of principles for use in scientific investigation. organon pl. organa [Gr.] organ. , is now available to help prevent blood clots Blood Clots Definition A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut. resulting from deep-vein thrombosis (DVT See deep vein thrombosis. ) in individuals who have undergone hip or knee replacement surgery, or surgery for a hip fracture hip fracture Orthopedic surgery A femoral fracture which affects 1/6 white ♀–US during life Epidemiology 250,000/yr–US Specifics Proximal femur; 90+% femoral neck, intertrochanteric; 5-10% are subtrochanteric Risk factors Tall, thin ♀, . DVT can lead to pulmonary embolism (PE), a life-threatening complication in which a blood clot that forms in the leg breaks off and migrates to the lung artery, where it can cause massive blockage of pulmonary circulation. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval of the drug was based on the results of a large clinical trial involving more than 7,000 patients worldwide. Studies reported that fondaparinux lowered the risk of DVT by 56% for hip fracture surgery and by 55% for knee replacement surgery, compared with enoxaparin. Lead investigator for the clinical trials, Alexander G.G. Turpie, MD, FRCP FRCP Fellow of the Royal College of Physicians. FRCP abbr. Fellow of the Royal College of Physicians , professor of medicine at McMaster University and internist at Hamilton Health Sciences Center in Ontario, Canada, said, "I've never in 40 years of clinical trial experience seen such a big benefit, particularly against an active and very effective drug." He further noted that it "demonstrated the lowest rate of deep-vein thrombosis ever recorded for hip fracture and hip or knee replacement clinical trials." This is the first drug to be approved by the FDA for DVT prevention after hip fracture surgery. Approximately 350,000 hip fractures occur annually in the United States, according to the American Academy of Orthopedic Surgeons. Twenty-four percent of patients 50 years of age and older who experience hip fracture die in the year after their fracture, in part because of complications. Approximately 60,000 people develop PE yearly and die of the complication. The most common side effect of this drug is bleeding. It is not recommended for patients with severely impaired kidney function or those who weigh less than 110 pounds; patients more than 75 years of age might be more likely to experience major bleeding complications. |
|
||||||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion