CIOMS FORM
DE-BFARM-16113389
SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH DA
MO
2a. AGE
3. SEX
YR
4-6 REACTION ONSET DA
MO
YR
Male
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
(cont.)
flacher werdende Atmung, beim Ausatmen musste die Luft ausgeblasen werden [ MedDRA 18.1 LLT (10038683): Respiratory disorder ] unerklärbares Herzunwohlsein, leichte Stiche, Heiß- oder Kaltgefühl, Herzbereich immer spürbar, unangenehmes Gefühl [ MedDRA 18.1 LLT (10054211): Cardiac discomfort ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: Bericht des Meldenden: Nach der Einnahme von Eliquis 5mg wegen erstmaligem Vorhofflimmern habe ich bisher nicht protokollierte Nebenwirkungen festgestellt: 1. Unerklärbares "Herzunwohlsein" - leichte Stiche, Heiß- oder Kaltgefühl, Herzbereich immer irgendwie spürbar, unangemehmes Gefühl aber zunächst keine körperliche Beeinträchtigung (später siehe 2). Keine Veränderung bei (leichterer) körperlicher Tätigkeit - Gedanken an Infarkt bzw. Nebenwirkung "Blutung im Herzbeutel" - keine Angstzustände 2. Irgendwann während der Einnahmezeit (nach 8-10 Tagen ?) flacher werdende Atmung (sah ich nicht im Zusammenhang mit Eliquis), beim Ausatmen habe ich häufiger die Luft ausblasen müssen, was mehr oder weniger "automatisch" geschah. So, als ob die "vegetative Atmungssteuerung" nicht
8-12 CHECK ALL APPROPRIATE TO ADVERSE REACTION
¨ 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 (cont.) 20. DID REACTION ABATE
14. SUSPECT DRUG(S) (include generic name)
AFTER STOPPING DRUG?
eliquis 5mg 15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
5 Mg milligram(s)
Oral
17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA 21. DID REACTION REAPPEAR AFTER REINTRODUCTION?
¨ YES ¨ NO ¨ NA
Atrial fibrillation 18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 18-JAN-2016 to 29-JAN-2016
12 Day III. CONCOMITANT DRUG(S) AND HISTORY
22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.)
(cont.)
[ MedDRA 18.1 (10074862): Mitral valve insufficiency ] Continuing: Unknown [ MedDRA 18.1 (10035664): Pneumonia ] from 1945 Continuing: Unknown [ MedDRA 18.1 (10019277): Heart disorder ] from 1952 Continuing: Unknown IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE 24b. MFR CONTROL NO.
DE-BFARM-16113389 24c. DATE RECEIVED BY MANUFACTURER
01-APR-2016 DATE OF THIS REPORT
07-APR-2016
24d. REPORT SOURCE
¨ STUDY ¨ LITERATURE ¨ HEALTH PROFESSIONAL 25a. REPORT TYPE
þ INITIAL ¨FOLLOW UP ¨ FINAL (Cont.) = Continuation on attached sheet(s)
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE
Continuation sheet for CIOMS report DE-BFARM-16113389
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
Report Date:
07-APR-2016
Report Page:
2 of 5
(... continuation ...)
funktionierte. Einnahmezeitraum: 18.01. bis 29.01.16 5 mg, ab 30.01.16: 2,5 mg wegen blutender Hautausschläge auf beiden Handrücken, Nebenwirkungen von Digimerck und Belok Zok. Ab 13/14.02.16 Zustand nach 1. Ab 18.02.16 abends Eliquis (2.5 mg) abgesetzt, nach da 12 h abklingende Beschwerden gem. 1. Zustand nach 2. blieb noch ca. 6-8 Tage - abflauend. Herzzustand: altersbezogen gut bis sehr gut, starke Herzmuskel (Leistungssport in Schulzeit und Jugend, Radtouren 150-200km/Tag). Aber: "leichte Mitralklappeninsuffizienz" (mit Prolaps des PZ). Ursache: Wohl starke Unterkühlung mit doppelseitiger Lungenentzündung Januar/Februar 1945. "Herzpkappern" im Schulkindalter (ca 1952/53) festgestellt - keine Diagnose möglich. Reaction text as reported MedDRA coding
Outcome* Term highlighted
Duration
Time interval 1** Time interval 2*** Start date
End date
unerklärbares Herzunwohlsein, leichte Stiche, Heiß- oder Kaltgefühl, Herzbereich immer spürbar, unangenehmes Gefühl [MedDRA 18.1 PT (10054211): recovering/resolving Cardiac discomfort ] [ MedDRA 18.1 LLT (10054211): Cardiac discomfort ] flacher werdende Atmung, beim Ausatmen musste die Luft ausgeblasen werden [MedDRA 18.1 PT (10038683): recovering/resolving Respiratory disorder ] [ MedDRA 18.1 LLT (10038683): Respiratory 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
14. Suspect Drug(s) (including generic name)
Unit
Normal low range
Normal high range
More inform. available
(... continuation ...)
Suspect Drug and batch no.
Start date
End date
eliquis 5mg
18-JAN- 29-JAN- 12 Day 2016 2016
Identification of the country where the drug was obtained
Duration
Dose *
A: Oral B: C: 5Mg milligram(s) D: E:
Deutschland
Name of holder/applicant 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
Route(s) of Administration
Deutschland
Indication(s) Atrial fibrillation
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE
Continuation sheet for CIOMS report DE-BFARM-16113389
Report Date:
07-APR-2016
Report Page:
3 of 5
Time interval between last dose of drug and start of reaction/event Dose reduced
Action(s) taken with drug 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 Active drug substance name apixaban 14. Suspect Drug(s) (including generic name)
(... continuation ...)
Suspect Drug and batch no.
Start date
End date
eliquis 2.5mg
30-JAN- 18-FEB- 20 Day 2016 2016
Identification of the country where the drug was obtained
Duration
Dose *
Route(s) of Administration
A: B: C: 2.5Mg milligram(s) D: E:
Oral
Indication(s)
Deutschland
Name of holder/applicant Authorization/Application Number Country of authorization/application
Deutschland
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 Active drug substance name apixaban 23. Other relevant history
(... continuation ...)
Reactions, Symptoms and Events
Start date End date
[ MedDRA 18.1 (10074862): Mitral valve insufficiency ] [ MedDRA 18.1 (10035664): Pneumonia ]
Continuing Comments Unknown
1945
Unknown
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE
Continuation sheet for CIOMS report DE-BFARM-16113389
[ MedDRA 18.1 (10019277): Heart disorder ]
1952
Unknown
Report Date:
07-APR-2016
Report Page:
4 of 5
im Schulkindalter (ca. 1952/53) festgestelltes "Herzklappern" - keine Diagnose möglich.
Patient past drug therapy Name of drug as reported
Indication MedDRA code
Reactions MedDRA code
digimerck
[ MedDRA 18.1 (0): unbekannt ]
[ MedDRA 18.1 (10058677): Skin bleeding ]
beloc-zok
[ MedDRA 18.1 (0): unbekannt ]
[ MedDRA 18.1 (10058677): Skin bleeding ]
Start date End date
ADMINISTRATIVE AND IDENTIFICATION INFORMATION
Safetyreportversion
1
Identification of the country where the reaction/event occur
Deutschland
Serious
No
Date Format of receipt of the most recent information for this report
20160401
Additional documents
No
List of documents held by sender Does this case fulfill the local criteria for an expedited report?
No
Regulatory authority's case report number Other case identifiers in previous transmissions Was the case medically confirmed, if not initially from health professional?
No
Primary source(s) of information Study name Reporter postcode Reporter country
Qualification
40
Consumer or other non health professional
Deutschland
Literature reference(s)
SENDER INFORMATION (... continuation ...) Type
Regulatory Authority
Organisation
BfArM
Department
Pharmakovigilanz
Street address
Kurt-Georg-Kiesinger-Allee 3
City
Bonn
Postcode
53175
Country
Deutschland
Fax
Sponsor study number
Study type in which the reaction(s)/event(s) were observed
BfArM Pharmakovigilanz Kurt-Georg-Kiesinger-Allee 3 53175 Bonn, DE
Continuation sheet for CIOMS report DE-BFARM-16113389
Telephone E-mail address
[email protected]
PATIENT INFORMATION (... continuation ...) Investigation number Gestation period Patient age group Weight (kg) Height (cm) Last menstrual periode date Text for relevant medical history and concurrent conditions
Report Date:
07-APR-2016
Report Page:
5 of 5