New Drug Update 2009-2010 - LAFP

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NEW DRUG UPDATE 2009-2010 FDA Safety Alerts 3-17 Quadravalent HPV Vaccine – Gardasil by Merck 18-22 Bivalent HPV Vaccine - Cervarix by GSK 22 Saxagliptin – Onglyza by BMS/Astra Zeneca 23-30 Liraglutide – Victoza by Novo-Nordisk 31-39 ADA/EASD and AACE/ACE Type 2 DM Guidelines 2009 39-40 IV Zoledronic acid – Reclast by Novartis 41-47 Febuxostat – Uloric by TAP 48-51 Dexlansoprazole- Kapidex by TAP NOW Dexilant 52-58 Milnacipran - Savella by Forest/Cypress 59-69 Tapentadol – Nucynta by ProCara, Ortho-McNeil, Jansen 70-77 Asenapine – Saphris by Schering Plough 78-83 Iloperidone – Fanapt by Vanda/Novartis 84-93 Prasugrel – Effient by Sankyo/Lilly 94-99 Dronedarone – Multaq by Sanofi Aventis 100-108 Benzyl alcohol lotion 5% - Ulesfia by Sciele 109-113 Guanfacine extended release – Intuniv by Shire 114-120 Pitavastatin - Livalo by Kowa and Lilly 121-122 Sipuleucel – T - Provenge by Dendreon Corp 123 Estradiol valerate and estradiol valerate/dienogest) 124-126 - Natazia by Bayer Ketorolac tromethamine Nasal Spray- Sprix 127-128 by Roxro Pharma Denosumab – Prolia by Amgen 129-133 Faculty Disclaimer: I am on the speaker’s bureau for Novartis in the area of hypertension and Pfizer in the areas of cardiovascular disease and pain. I am a consultant for Merck in the area of outcomes research. I will disclose any off label or investigational information. 2
FDA MedWatch Information 9/9/2006 Concomitant Use of Ibuprofen and Aspirin: Ibuprofen can interfere with the anti-platelet effect of low dose aspirin. “Patients who use immediate release aspirin (NOT enteric coated) and take a single dose of ibuprofen 400mg should dose the ibuprofen at least 30 minutes or longer after aspirin ingestion, or more than 8 hours before aspirin ingestion to avoid attenuation of aspirin’s effect.” “Other non-selective OTC NSAIDs should be viewed as having the potential to interfere with the anti-platelet effect of low dose aspirin unless proven otherwise.” The PRECISION trial, a large randomized comparison of celecoxib, naproxen, and ibuprofen in patients at moderate cardiovascular risk or with CVD with and without aspirin, started in 2006 but results are not expected until 2013.. 2/16/2007 FDA Alerts consumers to unsafe, misrepresented drugs purchased over the internet: The FDA has become aware that a number of Americans who have ordered prescription medications over the internet (Ambien, Xanax, Lexapro and Ativan) have received a product that based upon preliminary analysis contains haloperidol and antipsychotic that can cause muscle stiffness and spasms, agitation and sedation. The origin of these products is unknown but the packages were postmarked in Greece. The FDA is reissuing a warning to consumers about the possible dangers of buying prescription drugs on-line. Before you buy any prescription drug on-line make sure that it is a licensed and legitimate pharmacy with all of the built in safe guards. The National Association of Boards of Pharmacy (NABP) is a professional association of the state boards of pharmacy. It has a program to help find some of the pharmacies that are licensed to sell medicine online. They have identified 5750 on-line pharmacies and only 4% are ligitamate the remainder havebeen described as rougue by the NABP. Internet websites that display the seal of this program have been checked to make sure they meet state and federal rules. For more on this program and a list of pharmacies that display the Verified Internet Pharmacy Practice Sites Seal, (VIPPS ® Seal), go to www.vipps.info The Ryan Haight Online Pharmacy Consumer Protection Act, legislated and signed into federal law in 2008, is named for a teenager whose death resulted in part from the ease with which he acquired a narcotic drug over the Internet without a valid prescription. Haight was able to sign onto an Internet site posing as a legitimate pharmacy. He purchased a narcotic drug, which was delivered to his house, where he consumed the drug and died. The act implemented in April 2009 amended the Controlled Substances Act (part of 1970's Comprehensive Drug Abuse Prevention and Control Act) to prohibit delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription. The amendments included a definition of "online pharmacy" as well as registration, reporting, and Web site disclosure requirements for online pharmacies. October 3, 2007 FDA Acts to Ensure Thyroid Drugs Don’t Lose Potency Before Expiration Date The U.S. Food and Drug Administration is tightening the potency specifications for levothyroxine sodium, used to treat underactive thyroid glands and other thyroid conditions, to ensure the drug retains its potency over its entire shelf life. This action is being taken in response to concerns that the potency of the drug may deteriorate prior to its expiration date. The change will help improve the quality of the product so that consumers receive the level of medication needed to treat their thyroid disorders. Levothyroxine sodium products are used by over 13 million patients. FDA is mandating that levothyroxine sodium drug products tighten their potency specifications to meet a 95 percent to 105 percent potency specification until their expiration date. The shelf life is the length of time a drug can be stored before it degrades to unacceptable levels. The 95 percent lower potency specification will ensure the drugs do not degrade by more than 5 percent of the labeled claim before their expiration date and the 105 percent upper specification is appropriate to address occasional analytical testing variability. Traditionally these products were allowed a potency range of 90 to 110 percent. 3
Page 1: New Drug Update 2009-2010 C. Wayne
Page 5 and 6: 2002, to March 31, 2004. They ident
Page 7 and 8: The AGREE (Acute Gout Flare Receivi
Page 9 and 10: DM Only Group Total patients (n) Ca
Page 11 and 12: • Change the name of Maalox Total
Page 13 and 14: trivalent influenza vaccine (Fluzon
Page 15 and 16: about PCV2, a contaminant in RotaTe
Page 17 and 18: June 13, 2010 Modest lung-cancer si
Page 19 and 20: The primary analysis of efficacy wa
Page 21 and 22: Vaccine-related Injection-site and
Page 23 and 24: SAXAGLIPTIN - Onglyza (Bristol-Myer
Page 25 and 26: change from baseline (95% CI) (−1
Page 27 and 28: NNT—A 1c < 7% (compared with glyb
Page 29 and 30: exposure, but no change in exposure
Page 31 and 32: Liraglutide - Victoza by Novo-Nordi
Page 33 and 34: Difference from glimepiride + metfo
Page 35 and 36: Add-on to Metformin and Thiazolidin
Page 37 and 38: Headache 9.1 9.3 Influenza 7.4 3.6
Page 39 and 40: patient loses at least 3 percent of
Page 41 and 42: ZOLEDRONIC ACID INJECTION in Paget
Page 43 and 44: direct health care costs, found zol
Page 45 and 46: than a month after drug infusion. A
Page 47 and 48: Zoledronic acid and risedronate in
Page 49 and 50: Patients received either febuxostat
Page 51 and 52: NICE technology appraisal guidance
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lansoprazole. 1 In other pharmacody
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information recommends discontinuin
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GERD, the recommended dosage is 30
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MILNACIPRAN - Savella by Forest/Cyp
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Observed cases 2.12 (95% CI, 1.33 t
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pain score. On patient global asses
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eduction is recommended. Hyponatrem
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Palpitations 2% 8% 7% 7% Upper resp
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Agent Table 10. Dosage Forms for th
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19% unchanged in urine 3% unchanged
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Percentage rating study drug “goo
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Acute intoxication Warnings and Pre
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DOSING: Tapentadol may be taken ora
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In elderly patients with psychosis
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Investigations Weight increased
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3 mg tablets of repspiridone are $2
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Table 2. Pharmacokinetics of the Be
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haloperidol (P = 0.006). No differe
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Priapism X X X X Cognitive and moto
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Flatulence 1.9% 1.3% 1.6% 5.1% 2.3%
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adjustment in hepatic impairment re
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dosing, inhibition of platelet aggr
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thrombocytopenic purpura has been r
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“Despite the thumbs-up, the panel
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dronedarone and its N-debutyl metab
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ANDROMEDA Study (Increased Mortalit
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In clinical trials, patients treate
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Dronedarone was developed to lack a
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BENZYL ALCOHOL 5% LOTION - Ulesfia
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Table 2. Contraindications, Warning
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pediculocides, to improve outcomes.
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adolescents (ages 13-17), respectiv
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with TS+ADHD, aged 8 to 16 years. T
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HOW SUPPLIED/COST/STORAGE AND HANDL
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Pitavastatin - Livalo by Kowa and L
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Sipuleucel - T - Provenge by Dendre
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Women who are not pregnant and use
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Ketorolac tromethamine Nasal Spray-
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DENOSUMAB - Prolia by Amgen INDICAT
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71% for the pooled denosumab groups
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The most frequently observed advers
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New Drug Update 2009-2010 - LAFP

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