NIHS 医薬品安全性情報 Vol.16 No.012018/0111/

1 NIHS . NIHS 2018/01/11 .. FDA U. S. Food and Drug Administration . FAERS / 2017 4 6 .. 2. 2017 4 1 6 30 .. 7. 2017 7 1 9 30 .. 11. NIHS .. ' MedDRA-J .. 1. NIHS 2018/01/11 .. 2018 01/11 R01. FDA . FAERS / 2017 4 6 . Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April - June 2017. Surveillance 2017/10/06. FDA FAERS A 2017 4 6 . / . FDA . potential safety issue .. FDA . REMS B .. FDA FDA .. FDA .. A FDA Adverse Event Reporting System FAERS . 2196. 2017 9 28 FAERS FAERS Public Dashboard'.. NIHS 2017/12/27 . B Risk Evaluation and Mitigation Strategy 2. NIHS 2018/01/11 . FAERS / . /. 2017 9 30 .. Adrenalin epinephrine injection Adrenaline epinephrine FDA DHCP. letter C . Adrenalin' .. Adrenalin' DHCP .. Adrenalin DHCP letter Adrenalin' / .. Adrenalin' .. Adrenalin package insert labeling Aldara imiquimod 5% FDA .. Zyclara imiquimod .. Zyclara imiquimod .. Ameluz aminolevulinic acid Ameluz'.

2 Hydrochloride 10% . D .. Ameluz' . Ameluz labeling Campath alemtuzumab FDA .. Lemtrada alemtuzumab .. C Dear Healthcare Provider Letter D Patient Counseling Information 3. NIHS 2018/01/11 . carafate sucralfate carafate ' . carafate suspension' . carafate oral suspension' .. carafate ' . carafate oral suspension' .. carafate ' . carafate labeling Coartem artemether/lumefantrine FDA .. Epipen epinephrine injection FDA Meridian Medical Technologies USP Auto-injector mg . GMP E . Epipen Jr epinephrine injection . USP Auto-injector mg . Epipen' . Epipen Warning Letter E good manufacturing practice 4. NIHS 2018/01/11 . DPP-4 F linagliptin FDA . sitagliptin alogliptin saxagliptin .. Glyxambi empagliflozin/ linagliptin .. Janumet sitagliptin/ metformin hydrochloride . Janumet XR sitagliptin/ . metformin hydrochloride .. Januvia sitagliptin . Jentadueto linagliptin/ metformin hydrochloride . Jentadueto XR linagliptin/ . metformin hydrochloride .. Kazano alogliptin/ metformin hydrochloride.

3 Kombiglyze XR saxagliptin/ . metformin hydrochloride .. Nesina alogliptin . Onglyza saxagliptin . Oseni alogliptin/ pioglitazone .. Qtern dapagliflozin/ saxagliptin .. Tradjenta linagliptin . Gilenya fingolimod Fingolimod FDA .. Gleevec imatinib mesylate Gleevec' .. Gleevec' . Gleevec labeling GlucaGen glucagon [rDNA origin] FDA . for injection .. Glucagon .. F dipeptidyl peptidase-4. 5. NIHS 2018/01/11 . Keytruda pembrolizumab FDA .. Opdivo nivolumab .. Keytruda pembrolizumab Keytruda' .. Keytruda' . Keytruda labeling Pomalyst pomalidomide FDA .. FDA . Aciphex rabeprazole sodium .. Esomeprazole strontium .. Nexium esomeprazole magnesium .. Nexium esomeprazole magnesium .. Nexium esomeprazole sodium .. Prevacid lansoprazole .. Prevacid Solutab lansoprazole .. Prilosec omeprazole . Prilosec omeprazole .. Protonix pantoprazole sodium .. Protonix pantoprazole sodium .. Protonix IV pantoprazole sodium .. / FDA .. Repatha evolocumab FDA .. Taxotere docetaxel FDA.

4 Uvadex methoxsalen FDA .. 6. NIHS 2018/01/11 . 2018 01/11 R02. FDA . 2017 4 1 6 30 . Postmarket Drug and Biologic Safety Evaluations Completed from April 1, 2017 to June 30, 2017. Surveillance 2017/10/06. m#julsep_postmarket . 2007 9 27 NDA A BLA B. FDA .. 2007 FDA Food and Drug Administration Amendments Act FDAAA IX 915 18 . 1 C .. A New Drug Application B Biologics License Application C FDA 2017 7 21 . 2017 10 6 2017 7 9 . NIHS 2017/08/24 .. 7. NIHS 2018/01/11 . D.. NDA/BLA .. Aptensio XR FDA . methylphenidate ADHD E . hydrochloride .. NDA 205831. April 17, 2015. Aptiom 3 2017 9 13 . eslicarbazepine partial-onset Aptiom' . acetate seizure .. NDA 022416 NME F .. November 8, 2013 SIADH . SIADH G .. Jevtana cabazitaxel FDA .. NDA 201023 NME .. June 17, 2010. D 1 .. E attention deficit hyperactivity disorder F New Molecular Entity . G syndrome of inappropriate antidiuretic hormone secretion 8. NIHS 2018/01/11 . Opdivo nivolumab BRAF V600 3 FDA .. BLA 125527, 125554 BRAF V600.

5 NME .. December 22, 2014 Ipilimumab .. EGFR . ALK .. FDA .. Opdivo .. HSCT H . brentuximab vedotin .. 12 .. H hematopoietic stem cell transplantation 9. NIHS 2018/01/11 . Velphoro 2 2017 8 3 . sucroferric . oxyhydroxide .. NDA 205109 .. November 27, 2013. D.. NDA/BLA .. Corlanor ivabradine . NDA 206143 NME . April 15, 2015. Epiduo Forte adapalene and benzoyl peroxide . NDA 207917. July 15, 2015. Injectafer ferric carboxymaltose . NDA 203565. July 25, 2013. Noxafil posaconazole . NDA 205053. November 25, 2013. Otrexup methotrexate . NDA 204824. October 11, 2013. ProAir RespiClick (albuterol sulfate . NDA 205636. March 31, 2015. Tuzistra XR codeine polistirex/chlorpheniramine polistirex CIII. NDA 207768. April 30, 2015. Zarxio filgrastim-sndz . BLA 125553. March 6, 2015. Zortress everolimus . NDA 021560. April 20, 2010. 10. NIHS 2018/01/11 . 2018 01/11 R03. FDA . 2017 7 1 9 30 . Postmarket Drug and Biologic Safety Evaluations Completed July 1, 2017 to September 30, 2017.)

6 Surveillance 2017/10/06. m#Jul17 Sep17.. 2007 9 27 NDA A BLA B. FDA .. 2007 FDA Food and Drug Administration Amendments Act FDAAA IX 915 18 . 1 C .. A New Drug Application B Biologics License Application C FDA 2017 7 21 . 2017 10 6 2017 7 9 . NIHS 2017/08/24 .. 11. NIHS 2018/01/11 . D.. NDA/BLA .. Triumeq abacavir, HIV-1 E FDA . dolutegravir/ . lamivudine potential safety . issue .. NDA 205551. August 22, 2014. Viberzi eluxadoline FDA .. NDA 206940 NME F .. May 27, 2015 . D.. NDA/BLA .. Finacea azelaic acid 15% . NDA 207071. July 29, 2015. Humalog insulin lispro . NDA 205747. May 26, 2015. Ibrance palbociclib . NDA 207103 NME . February 3, 2015. Prezcobix darunavir/cobicistat . NDA 205395. January 29, 2015. Stiolto Respimat tiotropium bromide/olodaterol . NDA 206756. May 21, 2015. D 1 .. E human immunodeficiency virus F New Molecular Entity . 12. NIHS 2018/01/11 .. 13.