Pharmacy & Therapeutics - January 2009 - (Page 15) NEW DRUGS NEW DRUGS Generic Wellbutrin XL (Bupropion) for Depression The FDA has granted final approval of Impax Laboratories’ Abbreviated New Drug Application for a generic version of GlaxoSmithKline’s Wellbutrin XL 150 mg (bupropion extended-release tablets). An antidepressant, bupropion slows the absorption of dopamine and norepinephrine in the synapses between nerve cells. Source: Impax, November 28, 2008 DRUG NEWS bevacizumab had an increased risk of both all-grade and high-grade VTE. VTE is a major complication of cancer and an emerging problem with many angiogenesis inhibitors. Identifying the associated risks is a challenge because many randomized, controlled trials are not large enough to reveal the relationship. In this case, 15 studies were analyzed. Source: JAMA 2008;300:2277–2285 has now been approved for adults 19 to 64 years of age. The product protects against tetanus, diphtheria, and pertussis (whooping cough). Boostrix was previously approved as a booster vaccine for preteens and teenagers. The approval for adults was based on two clinical trials involving nearly 3,000 participants. Sources: FDA and GlaxoSmithKline, December 8, 2008 Tapentadol for Pain Relief Tapentadol HCl, a centrally acting synthetic analgesic, has been approved to alleviate moderate-to-severe acute pain. This immediate-release oral tablet is available in strengths of 50 mg, 75 mg, and 100 mg. Tapentadol acts as an opioid (narcotic) and as a non-opioid. The label warns about the risk of respiratory depression; addictive depressive effects on the central nervous system (CNS) when taken with alcohol and other opioids; and the potential for abuse. Sources: FDA and Janssen-Or tho/ PriCara, November 24, 2008 DRUG NEWS Boxed Warning For Colonoscopy Prep Products Acute phosphate nephropathy, a type of acute kidney injury, has been associated with the use of oral sodium phosphate products for bowel cleansing preceding colonoscopies. The products include Visicol and OsmoPrep tablets (Salix) as well as over-the-counter laxatives (e.g., Fleet Phospho-soda). It is possible that some patients were dehydrated before they used the product or did not drink sufficient fluids as directed. The kidney injury is associated with deposits of calcium-phosphate crystals in the renal tubules that can cause permanent renal impairment. The FDA is requiring Salix to add a boxed warning to the label, to implement a risk evaluation and mitigation strategy, and to provide a medication guide. Source: FDA, December 15, 2008 Warnings: Suicide and Epilepsy Drugs The FDA has ordered new warnings to be added to the prescribing information for drugs used to treat epilepsy, migraine, and some psychiatric disorders because of a potentially increased risk of suicidal thoughts and behaviors. A review of clinical studies revealed one additional case of suicidal thoughts or behaviors for ever y 500 patients who used an antiepileptic agent instead of a placebo. The war nings are required to be added to these products: carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR), clonazepam (Klonopin), clorazepate (Tranxene), divalproex (Depakote, Depakote ER, Depakene), ethosuximide (Zarontin), ethotoin (Peganone), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), lacosamide (Vimpat), levetiracetam (Keppra), mephenytoin (Mesantoin), methsuximide (Celontin), oxcarbazepine (Trileptal), phenytoin (Dilantin Suspension), pregabalin (Lyrica), primidone (Mysoline), tiagabine (Gabitril), topiramate (Topamax), trimethadione (Tridione), and zonisamide (Zonegran). Drug manufacturers have also been instructed to include a medication guide for patients. The new warning also applies to older epilepsy medications that weren’t included in the agency’s review. This will not be a black-box warning. The American Epilepsy Society said Extended-Cycle Oral Contraceptive (LoSeasonique) The FDA has approved Duramed’s New Drug Application for LoSeasonique (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg), the first lower-dose, extended-cycle oral contraceptive. Women take the tablets for 84 consecutive days, then take 0.01 mg of ethinyl estradiol tablets for seven days. The number of withdrawal bleeding periods is reduced from 13 to four per year. Source: Drugs.com, October 27, 2008 Thrombosis Risk With Bevacizumab (Avastin) Cancer patients who receive bevacizumab (Avastin, Genentech), an angiogenesis inhibitor, sometimes have a higher risk of venous thromboembolism (VTE). Anti-angiogenesis medications are widely used in cancer treatment. Reviewing data from 7,956 patients with advanced solid tumors, researchers at the State University of New York at Stony Brook, found that those receiving NEW INDICATIONS Boostrix Vaccine for Adults GlaxoSmithKline’s Boostrix vaccine Vol. 34 No. 1 • January 2009 • P&T® 15 http://www.Drugs.com
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