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1 Vol.1 o.38 ( ) IGIV FDA FDA.4 Ciprofloxacin.4 floxacin.5 rlistat.7 - Health Canada.9 - Health Canada.10 Health Canada.10 MHRA FDA 1. Immune Globulin Intravenous (Human) (IGIV); Required Updates to Product Labeling web FDA IGIV IGIV IGIV CBER IGIV IGIV 1
2 ARDS TRALI IGIV IGIV IGIV TRALI: Transfusion Related Acute Lung Injury IGIV TRALI TRALI 1 6 TRALI IGIV TRALI IGIV / IGIV IGIV / IGIV / 2
3 TRALI / 45 Special Labeling Supplement: Changes Being Effected 21CFR f 2 Special Labeling Supplement 1 Copelan EA, Strohm PL, Kennedy MS, Tutschka PJ. Hemolysis following intravenous immune globulin therapy. Transfusion 1986;26: Thomas MJ, Misbah SA, Chapel HM, Jones M, Elrington G, ewsom-davis J. Hemolysis after high-dose intravenous Ig. Blood 1993;15: Reinhart WH, Berchtold PE. Effect of high dose intravenous immunoglobulin therapy on blood rheology. Lancet 1992;339: Kessary-Shoham H. Levy Y, Shoenfeld Y, Lorber M, Gershon H. In vivo administration of intravenous immunoglobulin IVIg can lead to enhanced erythrocyte sequestration. J Autoimmune 1999;13: Rizk A, Gorson KC, Kenney L, Weinstein R. Transfusion-related acute lung injury after the infusion of IVIG. Transfusion 2001:41: Dalakas MC. High-dose intravenous Immunoglobulin and serum viscosity: risk of precipitating thromboembolic events. eurology, 44: Woodruff RK, Grigg AP, Firkin FC, Smith IL. Fatal thrombotic events during treatment of autoimmune thrombocytopenia with intravenous immunoglobulin in elderly patients. Lancet 1986; 2: Wolberg AS, Kon RH, Monroe DM, Hoffman M. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000; 65, Pierce LR, Jain. Risks associated with the use of intravenous immunoglobulin. Trans Med Rev 2003; 17, Human Immunoglobulins 3
4 2. Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies as of December 17, 2003 Alendronate Fosamax Merck Atovaquone and Proguanil Malarone GlaxoSmithKline Benazepril Lotensin ovartis Budesonide Pulmicort AstraZeneca Ciprofloxacin Ciloxan Alcon Fentanyl Duragesic ALZA Fexofenadine Allegra Aventis Fludarabine Fludara Berlex Fluticasone Flonase GlaxoSmithKline Fluticasone Flovent GlaxoSmithKline Fosinopril Monopril Bristol-Myers Squibb floxacin cuflox Allergan rlistat Xenical Hoffmann-La Roche xybutynin Ditropan Johnson & Johnson Temozolomide Temodar Schering Topotecan Hycamtin GlaxoSmithKline Venlafaxine Effexor Wyeth Ayerst web 1 Executive Summary Ciprofloxacin 1 sda /SE / Risk Management Steps 4 / Risk Management Steps 4
5 Ciprofloxacin Ciprofloxacin [ Ciloxan ] ciprofloxacin hydrochloride 0.3% 1 [ Ciloxan ] 0.3% 2 Ciprofloxacin DA ciloxan 0.3% 1 3 moxifloxacin 0.5%1 3 9 sda /SE [ Ciloxan ] 0.3%[ Ciloxan ] 61% 70% 10%[ Ciloxan ] moxifloxacin 53%9 80%[ Ciloxan ] [ Ciloxan ] 0.3% DA H HCl H 2 F C 2 H Ciprofloxacin Hydrochloride 2 Executive Summary floxacin 5
6 1 sda /SE floxacin ofloxacin 0.3% 1 1 floxacin DA ofloxacin0.3%[ cuflox ] trimethoprim sulfate/polymyxin b sulfate [ Polytrim ] 7 sda /SE [ cuflox ] 0.3% [ cuflox ]60%70% 10% 7 [ cuflox ] 55% [ Polytrim ] 50% [ cuflox ] [ Polytrim ]48% [ cuflox ] ofloxacin 0.3% H 3 C CH 3 H H 2 CH 3 F C 2 H H 2 H 3 C CH 3 floxacin Trimethoprim Phase I 1993/07/01 6
7 R Dbu-Thr-Dbu-Dbu-Dbu-D-Phe-Leu-Dbu-Dbu-Thr x H 2 S 4 B Polymyxin B Sulfate 3 Executive Summary rlistat 4 / Risk Management Steps Roche rlistat[ Xenical ] tetrahydrolipistatin rlistat BMI >30 kg/m 2 > 27 kg/m orlistat BMI>97% 52 2:1 32 1:1 1 65% orlistat BMI kg/m kg/m 2 P= % orlistat 15.7% BMI 5%P =0.005 orlistat 13.3% 4.5% BMI 10% P =0.002 orlistat 0.53 kg 3.1 kgp = % orlistat 31% 5% 27% orlistat 11% 7
8 1 10% orlistat 2.6cm 0.6cm P =0.008 orlistat 1.3cm 0.1cm P = orlistat 77 DEXA orlistat 0.54kg 1.45kg orlistat 2.4kg 0.38kg P = orlistat % orlistat 63% 52 orlistat 94% 22 orlistat 73% 72% orlistat orlistat orlistat 3.00 µg/dl orlistat 0.59 µg/dl P = E µmol/ L orlistat µmol/l P =0.089 orlistat orlistat rlistat QTc H 3 C H H 3 C CH 3 H H H H H CH 3 rlistat PhaseII 2002/11/12 8
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10 a Interferon- -1a genetical recombinant IF- agonist 2003/8/13 b interferon- -1b genetical recombinant IF- agonist 2. Advisory:Important safety information about the risk of liver injury in patients taking beta-interferon therapy Safety Warning Concerning the Use of Blue Food Dye in Enteral Feedings web FD & C Blue o FDA FD & C Blue o. 1 / FD & C Blue o. 1 Brilliant Blue FCF CAS o Health Canada Brilliant Blue Brilliant Blue Health Canada Brilliant Blue FCF 10
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Vol.2 o.10 (2004/05/27) MRA.1 [ Desyrel ] trazodone hydrochloride FDA.2 [ Zelnorm ] tegaserod hydrogen maleate ealth Canada.3 ealth Canada.5 [ Viread ] tenofovir disoproxil fumarate ealth Canada.5 [ rthoclone
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Vol.2 o.8 (2004/04/22) 2004 [ Clozaril ] clozapine DA.1 2004 [ Abilify ] aripiprazole DA.3 ealth Canada.4 Canadian Adverse Reaction ewsletter Vol.14 o.2 April 2004 ealth Canada Sterol sterolin.5 2003.6.7.8
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Vol.1 o.27 (2003. 10. 10) [ Reductil ] sibutramine MRA.1 [ Celance ] pergolide MRA.2 SAIDs MRA.3 MRA.3 [ Prandin ] repaglinide FDA.4 FD&C Blue o.1 FDA.5 [BDDrFVIII] [ ReFacto ] moroctocog- ealth Canada.6
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Vol.3 No.3 2005/02/10 Co-proxamol paracetamol/dextropropoxyphene MHRA.1 2005 1 28 FDA.3 FDA/CDER 2004 11 FDA.3 MCI[ Reminyl ] galantamine Health Canada.5 [ Lariam ] mefloquine Health Canada.5 [ Humira
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