CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-17150181 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DA MO YR 66 DA MO YR (Year) Female 13 04 2017 Blutzcker > 300mg/dl [ MedDRA 20.0 LLT (10005809): Blood sugar increased ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht der betroffenen Person: "Auf Grund meiner Erkrankungen Diabetes Typ II, Bluthochdruck und durch Operation entfernte Schilddrüse bekomme ich seit Juni folgende Medikamente: Toujeo Insulin glargin Hersteller: Sanofi-Aventis GmbH Humalog Insulin lispro Hersteller: Eli Lilly Italia S.p.A. L-Thyrox Hexal 200 µg Tabletten, Dosierung: 1 Tablette täglich Indapamid Heumann 1,5 mg Hersteller: Heumann Pharma, Dosierung: 1 Tablette täglich Atorvastatin STADA 20mg Filmtabletten, Dosierung: 1 Tablette täglich Valsacor 160 mg Filmtabletten, Dosierung: 1/2 Tablette täglich, Hersteller: KRKA, d.d. Amlodipin (besilat) Dexcel 5 mg Tabletten, Dosierung: 1 Tablette täglich Anfang April 2017 benötigte ich neue Medikamente. Mein Hausarzt stellte mir die Rezepte wie gewohnt aus. Auf Grund der Rabattverträge der Krankenkasse bekam ich jedoch in der Apotheke statt des Amlodipin von der Firma Dexcel, Amlodipin der Firma Fair-Med Healthcare AG. Daraufhin 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) Amlodipin Fair-Med Healthcare 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "daily dose: 1 Df dosage form every Day" { 1 Df dosage form, Oral 1 in 1 Day } 17. INDICATION(S) FOR USE Hypertension DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 13-APR-2017 3 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) Toujeo from humalog lispro from (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? YES NO NA (cont.) 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 20.0 (10045242): Type II diabetes mellitus ] from 2003 Continuing: Yes [ MedDRA 20.0 (10062127): Thyroidectomy ] Continuing: No [ MedDRA 20.0 (10048880): Smoker ] Continuing: Unknown (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 22-MAY-2017 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-17150181 24d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)
Report Page: 2 of 8 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) stieg mein Blutzuckerwert auf über 200 und bewegte sich innerhalb der nächsten 3 Tage zwischen 200 und 300 mg/dl, trotz Verdopplung der Insulineinheiten. Nach Absetzung des Medikamentes Amlodipin normalisierte sich unter Anwendung der ursprünglichen Insulineinheiten mein Blutzuckerwert wieder. Zusätzlich zu meiner gesundheitlichen Beeinträchtigung darf ich auch noch die Kosten für diese Experimente der Krankenkasse tragen. Weder die Apotheke, noch die Krankenkasse ist bereit, mir die Kosten für die Rezeptgebühr zu erstatten." Bericht des Arztes: Blutzucker-Entgleisungen >300 mg/dl ca. 2-3 Wochen nach Absetzen wieder normal (anamnestisch) Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Blutzcker > 300mg/dl [MedDRA 20.0 PT (10005557): Blood glucose increased ] 5 Day recovered/resolved 1 Day 13-APR-2017 17-APR-2017 [ MedDRA 20.0 LLT (10005809): Blood sugar increased ] * 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 Normal low range Normal high range More inform. available APR-2017 Blood glucose > 200 mg/dl 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug Duration Dose * Route(s) of Amlodipin Fair-Med Healthcare 13-APR- 2017 3 Day A: daily dose: 1 Df dosage form every Day C: 1Df dosage form Oral Hypertension Fair-Med Healthcare GmbH 245 (Tablet) Drug withdrawn 0-0-1
Report Page: 3 of 8 Cumulative dose number (to first reaction) C: Structure dosages number amlodipine besilate Causality assessment Reaction Source Method Result [ MedDRA 20.0 (10005809): Blood sugar increased ] Attending Physician Global Introspection (WHO GI) 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) unassessible/unclassi ficable Toujeo A: C: D: E: Sanofi-Aventis GmbH Cululative dose number (to first reaction) insulin glargine 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) humalog lispro A: C: D:
Report Page: 4 of 8 E: Cululative dose number (to first reaction) insulin lispro 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) l-thyrox hexal 200 µg A: daily dose: 200 µg microgram(s) every Day C: 200µg microgram(s)
Report Page: 5 of 8 Cululative dose number (to first reaction) levothyroxine sodium 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) valsacor 160 mg A: daily dose: 80 Mg milligram(s) every Day C: 80Mg milligram(s) Cululative dose number (to first reaction) valsartan 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) Indapamid Heumann 1,5 mg A: daily dose: 1.5 Mg milligram(s) every Day C: 1.5Mg milligram(s)
Report Page: 6 of 8 Heumann Pharma GmbH & Co. Generica KG Cululative dose number (to first reaction) indapamide 22. (s) and Dates of (exclude those used to treat reaction) (... continuation...) Atorvastatin STADA 20 mg A: daily dose: 20 Mg milligram(s) every Day C: 20Mg milligram(s) Stadapharm GmbH
Report Page: 7 of 8 Cululative dose number (to first reaction) atorvastatin calcium 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Continuing Comments [ MedDRA 20.0 (10045242): Type II diabetes mellitus ] 2003 Yes [ MedDRA 20.0 (10062127): Thyroidectomy ] No [ MedDRA 20.0 (10048880): Smoker ] Unknown ca. 30 Zigaretten/Tag [ MedDRA 20.0 (10014625): Encephalopathy ] Unknown Verdacht auf Encephalopathie [ MedDRA 20.0 (10015496): Essential tremor ] Unknown Verdacht auf essent. Tremor [ MedDRA 20.0 (10009122): Chronic renal impairment ] Unknown chronische Niereninsuffizienz Stad.III [ MedDRA 20.0 (10052242): Nephroangiosclerosis ] Unknown diabetisch/hypertensiv [ MedDRA 20.0 (10062060): Hyperlipidaemia ] Unknown [ MedDRA 20.0 (10050054): Strumectomy ] Unknown Z.n. Strumektomie Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-CADRBFARM-2017016525 Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code Amlodipin (maleat) Dexcel 5 mg [ MedDRA 20.0 (10020772): Hypertension ] [ MedDRA 20.0 (10067481): No adverse drug reaction ] 2017 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 No 20170522
Report Page: 8 of 8 Date Format of receipt of the most recent information for this report Additional documents No 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? No DE-CADRBFARM-2017016525 Yes 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 66 Consumer or other non health professional 66 Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority 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 Elderly >65.Lj. Weight (kg) 100 Height (cm) 168 Last menstrual periode Text for relevant medical history and concurrent conditions