Pharmacy & Therapeutics - May 2008 - (Page 268) NEW DRUGS attack in younger patients with no risk factors for cardiovascular disease may signify cocaine use, and some treatments intended for heart attacks can be fatal for these individuals. Cocaine, like heart attacks, can cause chest pain, shortness of breath, anxiety, palpitations, dizziness, nausea, and sweating. Only about 1% to 6% of patients with cocaine-associated chest pain are actually having a heart attack. Cocaine raises the heart rate and blood pressure. Two typical heart attack treatments can be dangerous to those using cocaine: clot-busting drugs carry a risk of bleeding into the brain in patients with hypertension that is caused by cocaine use, and beta blockers that lower blood pressure without constricting arteries in typical heart attack patients may actually raise blood pressure and squeeze arteries narrowed by cocaine use. (Sources: Circulation 2008;117:1897– 1907; Ann Emerg Med 2008;51:117–125.) DRUG NEWS ically compromised vertebral bodies at the level to be treated, or symptomatic cervical disc disease at more than one level. Benefit: The device stabilizes the spinal level after surgery. Unlike a fusion procedure, the replacement allows motion at the spinal level that has undergone surgery. After the diseased disc is removed, patients should experience pain relief and improved function. Source: www.fda.gov/cdrh/mda/ docs/p070001.html Name: Evicel Fibrin Sealant (Human) Manufacturer: Ethicon, Inc., and Omrix Biopharmaceuticals, Somerville, N.J. Approval Date: January 10, 2008 Use Classification: Evicel is the first fibrin sealant to be indicated as an adjunct to hemostasis for use in patients undergoing surger y when control of bleeding by standard surgical techniques is ineffective or impractical. The FDA originally licensed the predecessor of Evicel (Crosseal) in 2003 for use during liver surgery. Description: This sealant is sold as a frozen liquid. Less than one minute of preparation time is needed after thawing. Purpose: This is the only human plasma-derived fibrin sealant commercially available in the U.S. It does not contain aprotinin, which has been associated with adverse health effects. Contraindications: Evicel is not indicated for patients known to have anaphylactic or severe systemic reactions to human blood products. As with other plasma-derived products, the risk of transmitting infectious agents cannot be completely eliminated. Benefit: The sealant is easy to use and readily available for time-sensitive needs in the operating room. The success of a surgical procedure sometimes depends on the surgeon’s ability to control blood continued on page 303 the shin bone (tibia); and a plastic support (bearing) that sits on the tibial tray and mates with the curved femoral component. The plastic bearing slides in between the tibial tray and femoral component, which allows the artificial knee joint to move. Purpose: Patients may need knee replacement because of osteoarthritis, traumatic arthritis or physical injur y; avascular necrosis of the femoral condyle; or a moderate varus, valgus, or flexion deformity of the knee. Benefit: The painful portion of the knee joint is replaced, and the joint’s alignment and movement are restored. Source: www.fda.gov/cdrh/mda/ docs/p060037.html Name: ProDisc-C Total Disc Replacement Manufacturer: Synthes Spine, Inc., West Chester, Pa. Approval Date: December 17, 2007 Use Classification: The device is used to replace a diseased cervical disc. Description: The replacement consists of two metal (cobalt–chrome alloy) end-plates and an ultra-high-molecularweight polyethylene (plastic) inlay that fits between the two end-plates. Purpose: The plastic inlay and endplates restore the natural distance between the two vertebrae. The top endplate slides over the domed part of the plastic inlay, which allows movement at the level where it is implanted. The device is intended for skeletally mature patients for reconstruction of the disc from C3 to C7 cervical vertebrae after removal of the disc at one level for intractable symptomatic cervical disc disease. Contraindications: The replacement should not be implanted in patients with an active infection, an allergy to any of the device materials, osteoporosis, cervical instability, severe spondylosis, clin- Zotarolimus Coronary Stent The FDA has approved Medtronic’s Endeavor Zotarolimus-Eluting Coronary Stent to treat narrowed coronary arteries. This is the first drug-eluting stent approved since 2004. (Source: FDA, February 4, 2008.) NEW MEDICAL DEVICES Marvin M. Goldenberg, PhD, RPh, MS Name: NexGen LPS-Flex and LPSMobile Bearing Knees Manufacturer: Zimmer, Inc., Warsaw, Ind. Approval Date: December 10, 2007 Use Classification: These artificial mobile bearing knee systems are designed to replace the knee joint. Description: The knee systems have three parts: a metal curve-shaped part (a femoral component), which a doctor cements onto the end of the thigh bone; a flat metal tray cemented onto the top of 268 P&T® • May 2008 • Vol. 33 No. 5 http://www.fda.gov/cdrh/mda/docs/p070001.html http://www.fda.gov/cdrh/mda/docs/p070001.html http://www.fda.gov/cdrh/mda/docs/p060037.html http://www.fda.gov/cdrh/mda/docs/p060037.html
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