CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM-16158593 I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy DE DA MO YR 25 DA MO YR (Year) Male 02 05 2016 (10004161): Basedow's disease ] (10005750): Blood pressure increased ] Klinik einer Hyperthyreose, "Jod-Basedow-Effekt" bei topischer Anwendung von Povidon-Iod an frischen Piercings (10020850): Hyperthyroidism ] (10029216): Nervousness ] (10066996): Heart racing ] (10040984): Sleep disorder ] leichte Tachykardie (10043071): Tachycardia ] (10044565): Tremor ] (10047543): Visual disturbance ] Druckgefühl hinter den Augen (10058811): Sensation of pressure in eye ] Wärmeintoleranz (10057040): Temperature intolerance ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Am 27.04.2016 unter aseptischen Bedingungen 3 Piercings (Helixknorpel, Septum nasi, Unterlippe) gestochen. Ab 28.04.2016 Wundantiseptik mit Betaisodona Lösung (Povidon-Iod 11%). An den 8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION 7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED INVOLVED OR PROLONGED INPATIENT HOSPITALISATION INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY LIFE THREATENING CONGENITAL ANOMALY / BIRTH DEFECT OTHER MEDICALLY IMPORTANT CONDITION II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) betaisodona loesung (batch: 10091975) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "An den ersten beiden Tagen 1/1/1 dann 1/0/1" Topical 17. INDICATION(S) FOR USE Skin disinfection 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 28-APR-2016 to 01-MAY-2016 III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) 20. 21. DID REACTION ABATE AFTER STOPPING DRUG? YES NO NA DID REACTION REAPPEAR AFTER REINTRODUCTION? þ YES NO NA 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 19.0 (10036697): Primary hypothyroidism ] Continuing: [ MedDRA 19.0 (10050866): Cosmetic body piercing ] Continuing: [ MedDRA 19.0 (10048880): Smoker ] Continuing: Yes (cont.) 24a. NAME AND ADRESS OF SENDER 53175 Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER 20-MAY-2016 DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM-16158593 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 5 7. + 13. Describe Reaction(s) (including relevant tests/lab data) (... continuation...) ersten beiden Tagen dreimal täglich, dann zweimal täglich In der Nacht zum 02.05.2016 unruhiger Schlaf mit häufigem Hochschrecken und Herzrasen. Am 02.05.2016 Nervosität, Tremor, Wärmeintoleranz, subjektive Sehstörungen mit Druckgefühl hinter den Augen, leichte Tachykardie, RR 150/90. Betaisodona abgesetzt, auf iodfreies Präparat ausgewichen. Klinik einer Hyperthyreose, "Jod-Basedow-Effekt" bei topischer Anwendung von Povidon-Iod an frischen Piercings. Ergänzung: Wiederaufflammen nach experimenteller Reexposition. Spontanremission nach Präparatewechsel ->Antiseptik mit Octenidin fortgeführt. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date Klinik einer Hyperthyreose, "Jod-Basedow-Effekt" bei topischer Anwendung von Povidon-Iod an frischen Piercings [MedDRA 19.0 PT (10020850): Hyperthyroidism ] (10020850): Hyperthyroidism ] End date [MedDRA 19.0 PT (10004161): Basedow's disease ] (10004161): Basedow's disease ] [MedDRA 19.0 PT (10040984): Sleep disorder ] (10040984): Sleep disorder ] [MedDRA 19.0 PT (10033557): Palpitations ] (10066996): Heart racing ] [MedDRA 19.0 PT (10029216): Nervousness ] (10029216): Nervousness ] [MedDRA 19.0 PT (10044565): Tremor ] (10044565): Tremor ] Wärmeintoleranz [MedDRA 19.0 PT (10057040): Temperature intolerance ] (10057040): Temperature intolerance ] Druckgefühl hinter den Augen [MedDRA 19.0 PT (10052143): Ocular discomfort ] (10058811): Sensation of pressure in eye ] leichte Tachykardie [MedDRA 19.0 PT (10043071): Tachycardia ] (10043071): Tachycardia ]
Report Page: 3 of 5 [MedDRA 19.0 PT (10005750): Blood pressure increased ] (10005750): Blood pressure increased ] [MedDRA 19.0 PT (10047571): Visual impairment ] (10047543): Visual disturbance ] * Outcome of reaction/event at the time of last observation ** Time interval between beginning of suspect drug administration and start of reaction/event *** Time interval between last dose and start of reaction/event Results of tests Date Test Result Unit rmal low range rmal high range More inform. available Blood pressure 150/90 mmhg 14. Suspect Drug(s) (including generic name) (... continuation...) Suspect Drug and batch no. Start date End date Duration Dose * Route(s) of Administration Indication(s) betaisodona loesung (batch: 10091975) 28-APR- 2016 Identification of the country where the drug was obtained 01-MAY- 2016 A: An den ersten beiden Tagen 1/1/1 dann 1/0/1 B: C: D: E: Topical Skin disinfection Name of holder/applicant Mundipharma GmbH Authorization/Application Number Country of authorization/application Pharmaceutical form (Dosage form) Parent route of administration (in case of a parent child/fetus report) Gestation period at time of exposure Time interval between beginning of drug administration and start of reaction/event Time interval between last dose of drug and start of reaction/event Action(s) taken with drug Drug withdrawn Additional information on drug Did reaction reappear after reintroduction? * A: Dosage Text B: Cumulative dose number (to first reaction) C: Structure dosages number D: Number of separate dosages E: Number of units in the interval Yes Active drug substance name povidone-iodine
Report Page: 4 of 5 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 19.0 (10036697): Primary hypothyroidism ] ohne vorbekannte Thyreoiditiden [ MedDRA 19.0 (10050866): Cosmetic body piercing ] [ MedDRA 19.0 (10048880): Smoker ] Yes [ MedDRA 19.0 (10070526): Grass allergy ] Yes Gräserpollenallergie Report duplicates Duplicate source Paul-Ehrlich-Institut Duplicate number DE-PEI-WEBHUMAN_CONSUMER_2016035462 Parent Parent identification Date of birth Age LMP date Weight(kg) Height(cm) Sex Text for relevant medical history and concurrent conditions 0 ADMINISTRATIVE AND IDENTIFICATION INFORMATION Safetyreportversion 1 Identification of the country where the reaction/event occur Serious Date Format of receipt of the most recent information for this report Additional documents 20160520 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-2016012432 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 22 Consumer or other non health professional Consumer or other non health professional
Report Page: 5 of 5 SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode 53175 Country Fax Telephone E-mail address pharmakovigilanz@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 80 Height (cm) 174 Last menstrual periode date Text for relevant medical history and concurrent conditions