SUSPECT ADVERSE REACTION REPORT

Transcription

1 CIOMS FORM SUSPECT ADVERSE REACTION REPORT DE-BFARM I. REACTION INFORMATION 1. PATIENT INITIALS 1a. COUNTRY 2. DATE OF BIRTH 2a. AGE 3. SEX 4-6 REACTION ONSET privacy ( ): Circulatory instability ] entzugsähnliche Symptomatik ( ): Drug withdrawal syndrome ] ( ): Visual disturbance ] ( ): Light headedness ] ( ): Anxiety state ] Kopfdruck ( ): Head tightness ] ( ): Nervousness ] ( ): Nausea ] ( ): Panic disorder ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: DA MO YR 35 DA MO YR (Year) Female Ich habe am erstmals von dem Hersteller "Glenmark" Quetiapin Retardtabletten (Ch-B: S08692) eingenommen. In den vergangenen 6 Jahren habe ich Quetiapin retard von verschiedenen Herstellern eingenommen und keinerlei Probleme gehabt. Jetzt jedoch war ich vollständig handlungsunfähig aufgrund massivster Kreislaufdysregulation, Übelkeit, extremer II. SUSPECT DRUG(S) INFORMATION 8-1 CHECK ALL APPROPRIATE TO ADVERSE REACTION DESCRIBE REACTION(S) (including relevant tests/lab data) (cont.) PATIENT DIED 14. SUSPECT DRUG(S) (include generic name) quetiapin retard Glenmark (batch: S08692) 15. DAILY DOSE(S) 16. ROUTE(S) OF ADMINISTRATION "50mg" Oral 17. INDICATION(S) FOR USE Depression DE 18. THERAPY DATES (from/to) 19. THERAPY DURATION from 18-FEB- to 3 Day III. CONCOMITANT DRUG(S) AND HISTORY 22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction) (cont.) þ 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 23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.) [ MedDRA 18.1 ( ): Depression ] from DEC-2009 Continuing: [ MedDRA 18.1 ( ): Anxiety disorder ] from DEC-2009 Continuing: (cont.) 24a. NAME AND ADRESS OF SENDER Bonn, DE IV. SENDER INFORMATION 24c. DATE RECEIVED BY MANUFACTURER DATE OF THIS REPORT 24b. MFR CONTROL NO. DE-BFARM d. REPORT SOURCE þ STUDY 25a. REPORT TYPE LITERATURE HEALTH PROFESSIONAL þ INITIAL FOLLOW UP FINAL (Cont.) = Continuation on attached sheet(s)

2 Report Page: 2 of Describe Reaction(s) (including relevant tests/lab data) (... continuation...) Nervosität, Angst- und Panikzuständen, Schwindel, Sehstörungen, Symptome wie ich sie von Reduktionsversuchen der Arzneimitteldosis kenne- Absetzungssymptome. Was das ganze noch verschlimmert in meiner Wahrnehmung ist, dass ich in der 19. Woche schwanger bin und gerade jetzt sehr sensibel auf solche Ereignisse reagiere. Nachdem ich mir kurzfristig wieder Quetiapin von AbZ-Pharma besorgt hatte waren die massiven Symptome innerhalb 1h wieder deutlich besser bzw zu großen Teilen verschwunden. In der Rückschau kommt es mir vor als habe ich das Medikament einfach abgesetzt. Reaction text as reported MedDRA coding Duration Outcome* Term highlighted Time interval 1** Time interval 2*** Start date End date [MedDRA 18.1 PT ( ): Cardiovascular disorder ] ( ): Circulatory instability ] entzugsähnliche Symptomatik [MedDRA 18.1 PT ( ): Drug withdrawal syndrome ] ( ): Drug withdrawal syndrome ] 2 Day [MedDRA 18.1 PT ( ): Visual impairment ] ( ): Visual disturbance ] [MedDRA 18.1 PT ( ): Dizziness ] ( ): Light headedness ] [MedDRA 18.1 PT ( ): Anxiety ] ( ): Anxiety state ] Kopfdruck [MedDRA 18.1 PT ( ): Tension headache ] ( ): Head tightness ] [MedDRA 18.1 PT ( ): Nervousness ] ( ): Nervousness ] [MedDRA 18.1 PT ( ): Nausea ] ( ): Nausea ] [MedDRA 18.1 PT ( ): Panic disorder ]

3 Report Page: 3 of 5 ( ): Panic disorder ] * 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 Normal low range Normal high range More inform. available 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) quetiapin retard Glenmark (batch: S08692) 18-FEB- 20-FEB- 3 Day A: 50mg B: C: D: E: Oral Depression Identification of the country where the drug was obtained Name of holder/applicant Glenmark 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 19 Week 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 Additional information on drug Drug withdrawn Indikation:Depression und Angststörung, Augmentation der 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 Active drug substance name quetiapine Causality assessment Reaction Source Method Result [ MedDRA 18.1 ( ): Circulatory instability ] Certain [ MedDRA 18.1 ( ): Drug withdrawal syndrome ] Certain [ MedDRA 18.1 ( ): Visual disturbance ] [ MedDRA 18.1 ( ):

4 Report Page: 4 of 5 Light headedness ] [ MedDRA 18.1 ( ): Anxiety state ] [ MedDRA 18.1 ( ): Head tightness ] [ MedDRA 18.1 ( ): Nervousness ] [ MedDRA 18.1 ( ): Nausea ] [ MedDRA 18.1 ( ): Panic disorder ] 23. Other relevant history (... continuation...) Reactions, Symptoms and Events Start date End date Continuing Comments [ MedDRA 18.1 ( ): Depression ] DEC [ MedDRA 18.1 ( ): Anxiety disorder ] DEC Patient past drug therapy Name of drug as reported Indication MedDRA code Reactions MedDRA code Start date End date Quetiapin 50mg retard AbZ-Pharma und andere Hersteller [ MedDRA 18.1 ( ): Depression ] [ MedDRA 18.1 ( ): No adverse drug effect ] MAY Seroquel prolong 50mg Astrazeneca [ MedDRA 18.1 ( ): Depression ] [ MedDRA 18.1 (0): unbekannt ] MAY 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 Deutschland 0222 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

5 Report Page: 5 of 5 Was the case medically confirmed, if not initially from health professional? No Primary source(s) of information postcode country Qualification Literature reference(s) Study name Sponsor study number Study type in which the reaction(s)/event(s) were observed 56 Deutschland Physician SENDER INFORMATION (... continuation...) Type Organisation Department Regulatory Authority Street address City Bonn Postcode Country Deutschland Fax Telephone address pharmakovigilanz@bfarm.de PATIENT INFORMATION (... continuation...) Investigation number Gestation period 19 Week Patient age group Adult >18.Lj. bis einschl. 65.Lj. Weight (kg) 72 Height (cm) 175 Last menstrual periode date Text for relevant medical history and concurrent conditions