医薬品安全性情報 Vol.9 No.07 2011/03/31

1 2011/03/31 .. I . FDA U. S. Food and Drug Administration ..2. Abacavir ..4. PPI ..6. FDA/CDER 2011 1 ..10. MHRA Medicines and Healthcare products Regulatory Agency . Drug Safety Update Vol. 4 No. 7 2011. Lenalidomide: ..13. Omalizumab ..15. Health Canada . Methylene blue ..17. 1 ' . 2 MedDRA-J . 1. 2011/03/31 . I . 2011 03/31 R01. FDA .. Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns Drug Safety Communication 2011/02/22.. FDA . 3 . EPS.

2 Haldol' Clozaril' Risperdal' Zyprexa' Seroquel' Abilify' . Geodon' Invega' .. EPS .. 3 EPS / .. EPS .. FDA MedWatch A . A. 2. 2011/03/31 .. FDA Adverse Event Reporting System AERS 2008. 10 29 EPS 69.. 1 .. phenobarbital .. EPS .. Abilify aripiprazole Saphris asenapine Clozaril clozapine Seroquel quetiapine FazaClo ODT clozapine Seroquel XR quetiapine Fanapt iloperidone Stelazine trifluoperazine Geodon ziprasidone Thorazine chlorpromazine Haldol haloperidol Zyprexa olanzapine Invega paliperidone Zyprexa Relprevv olanzapine Invega Sustenna paliperidone Zyprexa Zydis olanzapine Loxitane loxapine Symbyax olanzapine and fluoxetine Moban molindone fluphenazine Navane thiothixene perphenazine Orap pimozide perphenazine and amitriptyline Risperdal

3 Risperidone prochlorperazine Risperdal Consta risperidone thioridazine 3. 2011/03/31 . 2011 03/31 R02. FDA . Abacavir . Safety Review update of Abacavir and possible increased risk of heart attack Drug Safety Communication 2011/03/01.. FDA abacavir . Abacavir HIV-1 . abacavir Ziagen' Trizivir' Epzicom' .. Abacavir Abacavir . 1 RCT . RCT .. FDA abacavir 26 . abacavir abacavir . abacavir . FDA .. Abacavir . Abacavir . FDA 26 . abacavir .. Abacavir FDA MedWatch A .. FDA abacavir 4 . International Pharmaceutical Abstracts IPA Intelos Embase Scopus.

4 Abacavir FDA . A. 4. 2011/03/31 . 50 . RCT . Mantel-Haenszel 95 . 3 . abacavir abacavir . 1996 2010 26 RCT 16 5 AIDS. ACTG B 5 FDA . Abacavir abacavir abacavir . abacavir 9,868 . 46 abacavir 5,028 24 abacavir 4,840 22 abacavir . Mantel-Haenszel 95%CI *1 .. FDA abacavir Ziagen ' abacavir .. 1 FDA URL . Abacavir Abacavir Sulfate JAN . NRTI HIV . B. AIDS Clinical Trials Group 5. 2011/03/31 . 2011 03/31 R03. FDA . PPI . Low magnesium levels can be associated with long-term use of Proton Pump Inhibitor drugs PPIs . Drug Safety Communication 2011/03/02.

5 FDA PPI 1 .. *1 4 1 . PPI . PPI GERD . 2009 2,100 . PPI PPI 180 6 .. PPI esomeprazole magnesium Nexium' dexlansoprazole Dexilant' . omeprazole Prilosec ' omeprazole/ Zegerid ' lansoprazole Prevacid' pantoprazole sodium Protonix' rabeprazole sodium AcipHex' . Vimovo' PPI esomeprazole magnesium/naproxen PPI. OTC omeprazole Prilosec OTC' omeprazole/ Zegerid OTC' lansoprazole Prevacid 24HR' . PPI PPI OTC 1 14 . 3 FDA PPI OTC .. PPI . PPI . PPI PPI digoxin . PPI . digoxin .. 6. 2011/03/31 .. PPI PPI . A .. PPI .. digoxin.

6 Furosemide bumetanide torsemide ethacrynic acid . chlorothiazide hydrochlorothiazide indapamide metolazone .. PPI .. 1 PPI .. PPI OTC .. PPI OTC .. FDA PPI AERS . PSUR . AERS 38 23 AERS 8 . 1-8 AERS . a . A. PPI OTC . 7. 2011/03/31 . b PPI . FDA PPI .. PPI .. PPI 3 . 1 4 1 PPI. positive dechallenge PPI . positive rechallenge PPI . PPI 1 . PPI 2 . PPI . Positive dechallenge 63 67 . PPI 6 11 .. PPI .. QT .. PPI PPI . 5 .. 1 Broeren MA, Geerdink EA, Vader HL, van den Wall Bake AW. Hypomagnesium induced by several proton-pump inhibitors.

7 Ann Intern Med 2009 . 151 10 ; 755-756. 2 Cundy T, Dissanayake A. Severe hypomagnesemia in long-term users of proton-pump inhibitors. Clinical Endocrinology 2008 . 69; 338-341. 3 Epstein M, McGrath S, Law F. Proton-pump inhibitors and hypomagnesemic hypoparathyroidism. NEJM. October 26, 2006. 355;17:1,834-1,836. 4 Hoorn EJ, MD, van der Hoek J, de Man RA, Kuipers EJ, et al. A case series of proton pump inhibitor induced hypomagnesemia. Am J Kidney Dis. February 25 2010. epub . 5 Kuipers MT, Thang HD, Arntzenius AB. Hypomagnesaemia due to use of proton pump inhibitors a review.

8 Neth J Med 2009 . 67 5 ;169-172. 6 Metz DC, Sostek MB, Ruszniewski P, Forsmark CE, et al. Effects of esomeprazole on acid output in 8. 2011/03/31 . patients with Zollinger-Ellison syndrome or idiopathic gastric acid hypersecretion. Am J. Gastroenterol. 2007 . 102 12 ; 2648-2654. 7 Shabajee N, Lamb E, Sturgess I, Sumathipala R. Omeprazole and refractory hypomagnesemia. BMJ. 2008 : 337; 173-175. 8 Mackay JD and Bladon PT. Hypomagnesaemia due to proton-pump inhibitor therapy: a clinical case series. QJ Med 2010; 103:387-395.

9 1 Safety Information .. Lareb 2010/07/22 , NZ MEDSAFE 2010/07/22 . Esomeprazole PPI 2011/01/07 .. Dexlansoprazole PPI Phase 2011 3.. Omeprazole PPI . Lansoprazole PPI . Pantoprazole PPI . Rabeprazole Sodium Rabeprazole JAN . PPI . 3 .. 9. 2011/03/31 . 2011 03/31 R04. FDA . FDA/CDER 2011 1 . 2011 Summary view: safety labeling changes approved by FDA Center for Drug Evaluation and Research CDER January FDA MedWatch 2011/02/17.. A.. BW boxed warning C contraindications W warnings . P precautions AR adverse reactions . PPI/MG Patient Package Insert/Medication Guide REMS Risk Evaluation and Mitigation Strategy PCI Patient Counseling Information.

10 BW C W P AR PPI/MG. Carbatrol carbamazepine Extended-Release Capsules MG. EES erythromycin ethylsuccinate Granules for Oral Suspension . Ery-Ped erythromycin ethylsuccinate Liquids PCE erythromycin particles in tablets . Dispertab Tablet . Gelnique oxybutynin chloride 10% gel . Uloric febuxostat tablets .. Zithromax azithromycin tablet, single-dose packet, IV for injection, and oral suspension . Actonel risedronate sodium tablets MG. * Bisphosphonates Class Label Change Actonel with Calcium risedronate sodium with calcium carbonate tablets, USP.