Pharmacy & Therapeutics- July 2008 - (Page 387) NEW DRUGS NEW INDICATIONS Zoledronic Acid (Reclast) To Prevent New Fractures The Food and Drug Administration (FDA) has broadened the U.S. indication for once-yearly zoledronic acid Injection (Reclast, Novartis) to include the prevention of new clinical fractures in patients who have recently had a lowtrauma hip fracture. This fracture results from a fall from standing height or less. The new indication was based on data from the Recurrent Fracture Trial, which included more than 2,100 men and women aged 50 and older with osteoporosis who had experienced a recent low-trauma hip fracture. Reclast increased bone mineral density and reduced the risk of new clinical fractures by 35%, compared with placebo. The risk of new spine fractures was reduced by 46%. Known as Aclasta in Europe, Reclast is given once yearly as a 15-minute intravenous infusion. It is already approved to treat postmenopausal osteoporosis and Paget’s disease of bone. Zoledronic acid is also available as Zometa Injection for cancer treatment. (Sources: N Engl J Med 2008;59:762– 784; Novartis, June 5, 2008, www. reclast. com.) DRUG NEWS Morphine Sulfate Tablets Ethex Corporation has notified health care professionals of a voluntary recall of a single lot of morphine sulfate 60-mg extended-release tablets (Lot No. 91762), because a tablet with twice the appropriate thickness was reported. Oversized tablets may contain as much as two times the labeled level of active drug. The lot was distributed under an Ethex label between April 16 and 27, 2008. Debilitated patients might not be able to tell that a tablet is overweight or oversized. Overdoses of opioids such as morphine can be life-threatening. (Sources: FDA, June 10, 2008; Ethex.) generalized anxiety disorder. (Source: Eli Lilly, June 16, 2008.) Bortezomib (Velcade) for Untreated Multiple Myeloma Millennium Pharmaceuticals, Takeda Oncology, and Takeda Pharmaceutical Company Ltd. have announced the FDA’s approval of bortezomib (Velcade) for patients with previously untreated multiple myeloma (MM). In the U.S., this agent is indicated for patients with MM and for patients with mantle-cell lymphoma who have received at least one previous therapy. This medication is contraindicated for patients with a hypersensitivity to bor tezomib, boron, or mannitol. (Source: Millennium, June 20, 2008.) Boxed Warnings Added Older Antipsychotic Drugs The FDA is requiring manufacturers of conventional (first-generation, or “typical”) antipsychotic drugs to make safetyrelated changes to the labeling to warn about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia. In 2005, the FDA announced similar labeling changes for “atypical” (second-generation) antipsychotic drugs, and boxed warnings were added at that time. The warnings will now apply to both drug classes, and all of the drug labels will carry uniform language. Both classes of drugs block naturally occurring dopamine in the brain. Atypical drugs are associated with fewer neurological side effects such as involuntary movements. However, neither drug class is approved for treating dementia-related symptoms. The agents are approved primarily to treat symptoms associated with schizophrenia. The decision to use these drugs off-label to treat dementia symptoms is left to the discretion of the physician. The conventional agents include prochlorperazine (Compazine); haloperidol DRUG NEWS Recalls Xiadafil VIP Tabs The FDA has requested that SEI Pharmaceuticals recall all Xiadafil VIP Tabs sold in eight-tablet bottles (Lot No. 6K029) or blister cards of two tablets (Lot No. 6K029-SEI) with an expiration date of September 2009. These products contain a potentially harmful, undeclared ingredient that can lower blood pressure to dangerous levels. The tablets are marketed as a dietary supplement for sexual enhancement and for treating erectile dysfunction. The illegal ingredient, hydroxyhomosildenafil, is an analogue of sildenafil, the active ingredient in Pfizer’s Viagra. It may interact with nitrates such as nitroglycerin. The FDA has not approved Xiadafil VIP Tabs for erectile dysfunction or any other use. The product is sold over the Internet, as free samples at trade shows, and in health food stores. The FDA is advising consumers not to buy or use this product. (Source: FDA, May 29, 2008.) Duloxetine for Fibromyalgia Eli Lilly’s duloxetine HCl (Cymbalta) has been approved for the management of fibromyalgia, a chronic pain disorder. This agent is a serotonin–norepinephrine reuptake inhibitor (SNRI). The cause of fibromyalgia remains unknown, but it might be related to a combination of changes in brain and spinal cord chemistr y, genetics, and stress. Fibromyalgia affects about 2% of the U.S. population (five million people), and most patients are women. Duloxetine is also approved for adults with diabetic peripheral neuropathic pain, major depressive disorder, and Vol. 33 No. 7 • July 2008 • P&T® 387
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.