CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17200253 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 49 DA MO YR (Year) Female 08 04 2011 innere Unruhe (10038743): Restlessness ] Angespanntheit (10043267): Tenseness ] Schlafstörungen (10040984): Sleep disorder ] Magen- und Darmprobleme (10054209): Gastrointestinal discomfort ] Allergien (10001740): Allergy multiple ] Kopfschmerzen (10019211): Headache ] Rückenschmerzen (10003988): Back pain ] Angststörungen (10057666): Anxiety disorder ] Herzrasen (10066996): Heart racing ] Erschöpfungszustände (10015667): Exhaustion ] Depressionen (10012378): Depression ] Grundlose Traurigkeit (10016364): Feeling sad ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Meldung aus der Bevölkerung Im Laufe der 15 Jahre hatte ich diverse Nebenwirkungen, die ich anfänglich nicht mit der Mirena in Zusammenhang gebracht habe. Im April 2011 bekam ich Depressionen und Angststörunven. Im II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) Mirena 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION Intra-uterine 17. INDICATION(S) FOR USE Contraception DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 05-AUG-2001 to JUL-2016 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) Opipramol Sertralin from JUN-2012 to 2015 (cont.) 20. 21. INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? þ YES NO NA (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 06-JUN-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17200253 24d. REPORT SOURCE STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 7 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Juli 2011 stand ein Wechsel der Spirale an. Ich fragte meinen Frauenarzt, ob es einen Zusammenhang von Spirale und Depressionen sowie Angststörungen gibt. Das hat er vehement bestritten. Also bekam ich die dritte Spirale. Anfänglich wurde mir Opipramol verschrieben. Nach dem Absetzen gingen die Depressionen und Angststörungen wieder los. Ab Juni 2012 bekam ich 50 mg Sertralin. Das habe ich auf Anraten meines Neurologen im Juni 2015 ausgeschlichen. Sechs Wochen später, alles noch unter der Mirena, hatte ich wieder Depressionen. Ich nahm wieder Sertralin. Im Juli 2016 wurde mir die Spirale gezogen. Zeitgleich bin ich auf Escitalopram umgestiegen, das ich jetzt seit Mai 2017 ausgeschlichen habe. Nach dem Ziehen der Spirale waren meine Depressionen und Angststörungen weg. Ich hatte zwar zwischendurch nochmal kleine Tiefs, die aber wohl mit dem Abbau der Hormone zu tun hatten. Ich kann nur sagen, dass es seit dem Ziehen der Spirale stetig bergauf gegangen ist. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Grundlose Traurigkeit [MedDRA 20.0 PT (10012374): Depressed mood ] (10016364): Feeling sad ] innere Unruhe [MedDRA 20.0 PT (10038743): Restlessness ] (10038743): Restlessness ] Angespanntheit [MedDRA 20.0 PT (10043268): Tension ] (10043267): Tenseness ] Schlafstörungen [MedDRA 20.0 PT (10040984): Sleep disorder ] (10040984): Sleep disorder ] Magen- und Darmprobleme [MedDRA 20.0 PT (10000059): Abdominal discomfort ] (10054209): Gastrointestinal discomfort ] Allergien [MedDRA 20.0 PT (10028164): Multiple allergies ] (10001740): Allergy multiple ] Kopfschmerzen [MedDRA 20.0 PT (10019211): Headache ] (10019211): Headache ] Rückenschmerzen [MedDRA 20.0 PT (10003988): Back pain ]
Report Page: 3 of 7 (10003988): Back pain ] Angststörungen [MedDRA 20.0 PT (10057666): Anxiety disorder ] (10057666): Anxiety disorder ] Herzrasen [MedDRA 20.0 PT (10033557): Palpitations ] (10066996): Heart racing ] Erschöpfungszustände [MedDRA 20.0 PT (10016256): Fatigue ] (10015667): Exhaustion ] Depressionen [MedDRA 20.0 PT (10012378): Depression ] (10012378): Depression ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug *** and start of reaction/event Results of tests Date Test Result Unit rmal low range rmal high range More inform. available 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of Mirena 05-AUG- JUL- 2001 2016 A: C: Intra-uterine Contraception
Report Page: 4 of 7 Drug withdrawn Cumulative dose number (to first reaction) C: Structure dosages number Number of separate dosages Number of units in the interval NA levonorgestrel 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of Opipramol A: C: Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages Number of units in the interval opipramol 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of Sertralin JUN- 2012 2015 A:
Report Page: 5 of 7 C: 50Mg milligram(s) Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages Number of units in the interval sertraline 22. Concomitant Drug(s) and Dates of (exclude those used to treat reaction) (... continuation...) Concomitant Drug Duration Dose * Route(s) of Escitalopram A: C:
Report Page: 6 of 7 Cululative dose number (to first reaction) C: Structure of separate dosages Number of separate dosages Number of units in the interval escitalopram Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2017016946 Parent Parent identification Date of birth Age LMP Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 20170606 List of documents held by sender Does this case fulfill the local criteria for an expedited report? Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional? DE-CADRBFARM-2017016946 Yes Primary source(s) of information Reporter postcode Reporter country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 46 Consumer or other non health professional SENDER INFORMATION (... continuation...) Type Regulatory Authority
Report Page: 7 of 7 Organisation Department Street address City Bonn Postcode 53175 Country Fax Telephone E-mail address uaw@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 63 Height (cm) 170 Last menstrual periode Text for relevant medical history and concurrent conditions