CIOMS Report

CIOMS FORM
DE-BFARM-15376632
SUSPECT ADVERSE REACTION REPORT
I. REACTION INFORMATION
1. PATIENT INITIALS
1a. COUNTRY
privacy
DE
2. DATE OF BIRTH
DA
MO
YR
2a. AGE
72
(Year)
3. SEX
4-6 REACTION ONSET
DA
MO
YR
Female
13
11
2015
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
(cont.)
sehr starke Hitzewallungen [ MedDRA 18.1 LLT (10020408): Hot flushes ]
starkes Schwitzen am Kopf [ MedDRA 18.1 LLT (10019362): Heavy sweating ]
[ MedDRA 18.1 LLT (10009197): Circulatory instability ]
Schwarzsehen [ MedDRA 18.1 LLT (10047508): Vision abnormal ]
sehr starke Panikattacke [ MedDRA 18.1 LLT (10033664): Panic attack ]
starke Schweißausbrüche [ MedDRA 18.1 LLT (10042663): Sweating attack ]
Benommenheit [ MedDRA 18.1 LLT (10018263): Giddiness ]
[ MedDRA 18.1 LLT (10013573): Dizziness ]
Case narrative including clinical course, therapeutic measures, outcome and additional relevant
information:
Seit 21.09.2015 nachm ich das Medikament Diclo KD 75 akut sporadisch bei starken Schmerzen.
Zeitgleich hatte ich starke Schweissausbrüche und Benommenheit. Am 10. oder 11.11. riet die Ärztin,
die Tabletten täglich zu nehmen. Am 13.11.2015 nahm ich morgens und gegen 14.00 Uhr je eine Diclo
KD 75 akut und ging sparzieren. Unterwegs bekam ich starke Hitzewallungen, das Wasser lief mir
aus den Haaren, mir wurde schwindelig und ich bekam schwere Ängste, dass ich nicht mehr nach
Hause komme. Wieder zu Hause hatte ich Todesangst und nahm Beruhigungstropfen. Nach ca. 1-2
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
/ BIRTH
¨ ANOMALY
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?
diclo kd 75 akut
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
"bei Bedarf" { 75 Mg milligram(s) }
Oral
17. INDICATION(S) FOR USE
¨YES ¨NO ¨NA
21. DID REACTION
REAPPEAR AFTER
REINTRODUCTION?
¨YES ¨NO ¨NA
Back pain
18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 21-SEP-2015
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 (10057322): Intervertebral disc operation ]
Continuing: No
[ MedDRA 18.1 (10013707): Drug-induced parkinsonism ]
Continuing: Unknown
[ MedDRA 18.1 (10003597): Ataxic gait ]
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-15376632
24c. DATE RECEIVED BY
MANUFACTURER
21-JAN-2016
DATE OF THIS REPORT
28-JAN-2016
24d. REPORT SOURCE
¨ STUDY ¨LITERATURE
þ HEALTH PROFESSIONAL
25a. REPORT TYPE
¨INITIAL þFOLLOW UP ¨FINAL
(Cont.) = Continuation on attached sheet(s)
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date:
Report Page:
DE-BFARM-15376632
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
28-JAN-2016
2 of 5
(... continuation ...)
Stunden, in denen es mir sehr schlecht ging, beruhigte ich mich wieder.
Ich bin jetzt wieder zu Voltaren Resinat gewechselt, weil ich diese sehr gut vertrage.
Bemerken möchte ich noch, dass ich auch schon durch Medikamente ein Parkinsonoid und Rumpf- und Gangataxien hatte.
Reaction text as reported
MedDRA coding
sehr starke Hitzewallungen
[MedDRA 18.1 PT (10060800):
Hot flush ]
Duration
Outcome*
Term highlighted
Time interval 1**
Time interval 2***
Start date
recovered/resolved
13-NOV-2015
recovered/resolved
13-NOV-2015
recovered/resolved
13-NOV-2015
recovered/resolved
13-NOV-2015
recovered/resolved
13-NOV-2015
recovered/resolved
SEP-2015
recovered/resolved
SEP-2015
recovered/resolved
13-NOV-2015
End date
[ MedDRA 18.1 LLT (10020408):
Hot flushes ]
starkes Schwitzen am Kopf
[MedDRA 18.1 PT (10020642):
Hyperhidrosis ]
[ MedDRA 18.1 LLT (10019362):
Heavy sweating ]
[MedDRA 18.1 PT (10007649):
Cardiovascular disorder ]
[ MedDRA 18.1 LLT (10009197):
Circulatory instability ]
Schwarzsehen
[MedDRA 18.1 PT (10047571):
Visual impairment ]
[ MedDRA 18.1 LLT (10047508):
Vision abnormal ]
sehr starke Panikattacke
[MedDRA 18.1 PT (10033664):
Panic attack ]
[ MedDRA 18.1 LLT (10033664):
Panic attack ]
starke Schweißausbrüche
[MedDRA 18.1 PT (10020642):
Hyperhidrosis ]
[ MedDRA 18.1 LLT (10042663):
Sweating attack ]
Benommenheit
[MedDRA 18.1 PT (10013573):
Dizziness ]
[ MedDRA 18.1 LLT (10018263):
Giddiness ]
[MedDRA 18.1 PT (10013573):
Dizziness ]
[ MedDRA 18.1 LLT (10013573):
Dizziness ]
* 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
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date:
Report Page:
DE-BFARM-15376632
14. Suspect Drug(s) (including generic name)
Suspect Drug
and batch no.
Start
date
diclo kd 75 akut
21-SEP2015
28-JAN-2016
3 of 5
(... continuation ...)
End
date
Duration
Dose *
Route(s) of
Administration
A: bei Bedarf
Oral
B:
C: 75Mg milligram(s)
D:
E:
Identification of the country
where the drug was obtained
Deutschland
Name of holder/applicant
Dr. Kade Pharma
Indication(s)
Back pain
Authorization/Application Number
Country of authorization/application
Deutschland
Pharmaceutical form (Dosage form)
245 (Tablet)
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
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
diclofenac sodium
14. Suspect Drug(s) (including generic name)
(... continuation ...)
Suspect Drug
and batch no.
Start
date
End
date
diclo kd 75 akut
13-NOV- 13-NOV2015
2015
Duration
Dose *
A: daily dose: 150
Oral
Mg milligram(s)
every Day
B: 11100Mg
milligram(s)
C: 75Mg milligram(s)
D: 2
E: 1Day
Identification of the country
where the drug was obtained
Deutschland
Name of holder/applicant
Dr. Kade Pharma
Authorization/Application Number
Country of authorization/application
Deutschland
Pharmaceutical form (Dosage form)
245 (Tablet)
Parent route of administration
(in case of a parent child/fetus report)
Route(s) of
Administration
Indication(s)
Back pain
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date:
Report Page:
DE-BFARM-15376632
28-JAN-2016
4 of 5
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
Drug withdrawn
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
diclofenac sodium
23. Other relevant history
(... continuation ...)
Reactions, Symptoms and Events
Start date
End date
Continuing
Comments
[ MedDRA 18.1 (10057322): Intervertebral disc operation ]
No
Zust.n. Bandscheiben-OP
[ MedDRA 18.1 (10013707): Drug-induced parkinsonism ]
Unknown
[ MedDRA 18.1 (10003597): Ataxic gait ]
Unknown
[ MedDRA 18.1 (10003591): Ataxia ]
Unknown
Rumpfataxie
[ MedDRA 18.1 (10041597): Spinal stenosis of lumbar region ]
Unknown
Spinalkanalstenose L3/4 L4/5
Report duplicates
Duplicate source
Duplicate number
Paul-Ehrlich-Institut
DE-CADRBFARM-2015010649
Patient past drug therapy
Name of drug as reported
voltaren resinat
Indication MedDRA code
Reactions MedDRA code
[ MedDRA 18.1 (0): unbekannt ]
[ MedDRA 18.1 (10052808): No
adverse drug effect ]
Parent
Parent identification
Date of birth
Age
LMP date
Weight(kg) Height(cm) Sex
0
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
20160121
Start date End date
Text for relevant medical history
and concurrent conditions
BfArM
Pharmakovigilanz
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn, DE
Continuation sheet for CIOMS report
Report Date:
Report Page:
DE-BFARM-15376632
28-JAN-2016
5 of 5
No
Additional documents
List of documents held by sender
Does this case fulfill the local criteria for an
expedited report?
No
Regulatory authority's case report number
DE-CADRBFARM-2015010649
Other case identifiers in previous transmissions Yes
Was the case medically confirmed, if not
initially from health professional?
Yes
Primary source(s) of information
Study name
Reporter postcode
Reporter country
Qualification
Literature reference(s)
26
Deutschland
Consumer or other
non health
professional
26
Deutschland
Physician
SENDER INFORMATION (... continuation ...)
Type
Regulatory Authority
Organisation
BfArM
Department
Pharmakovigilanz
Street address
Kurt-Georg-Kiesinger-Allee 3
City
Bonn
Postcode
53175
Country
Deutschland
Fax
Telephone
E-mail address
[email protected]
PATIENT INFORMATION (... continuation ...)
Investigation number
Gestation period
Patient age group
Elderly
Weight (kg)
84
Height (cm)
169
Last menstrual periode date
Text for relevant medical history and
concurrent conditions
>65.Lj.
Sponsor study number
Study type in which the
reaction(s)/event(s)
were observed