CIOMS FORM
DE-BFARM-17174538
SUSPECT ADVERSE REACTION REPORT I. REACTION INFORMATION 1. PATIENT INITIALS
1a. COUNTRY
DE
privacy
2. DATE OF BIRTH DA MO YR
2a. AGE
51 (Year)
3. SEX
4-6 REACTION ONSET DA MO YR
Female
02
7. + 13. DESCRIBE REACTION(S) (including relevant tests/lab data)
8-1
2017 (cont.)
[ MedDRA 20.0 LLT (10044055): Toothache ] [ MedDRA 20.0 LLT (10049870): Tongue haemorrhage ] unter 50 mg Topamax Übelkeit morgens [ MedDRA 20.0 LLT (10028813): Nausea ] [ MedDRA 20.0 LLT (10013781): Dry mouth ] [ MedDRA 20.0 LLT (10018290): Gingival recession ] [ MedDRA 20.0 LLT (10013781): Dry mouth ] Case narrative including clinical course, therapeutic measures, outcome and additional relevant information:
CHECK ALL APPROPRIATE TO ADVERSE REACTION
¨ PATIENT DIED ¨
INVOLVED OR PROLONGED INPATIENT HOSPITALISATION
¨
INVOLVED PERSISTENCE OR SIGNIFICANT DISABILITY OR INCAPACITY
¨ LIFE THREATENING
Mundtrockenheit mit Zahnfleischrückgang
CONGENITAL
Genaue Beschreibung der UAW-Syxnptomatik: ANOMALY / BIRTH Bipolarer Pat. mit Schlafstörungen, Müdigkeit, bedrückt, antriebsgestört. Beginn Topamax am DEFECT 3.2.17, am 17.2. Wiedervorstellung: es gehe etwas besser, wirkt schwungvoller, weniger müde. Unter 50mg Topamax-Übelkeit morgens, Zahnfleischprobleme, Zungenbluten, alle Zähne tun wehOTHER MEDICALLY keine Feuchtigkeit im Mund (man muss viel trinken bei dem Medikament). 20.3.2017: IMPORTANT Mundtrockenheit, Zahnschmerzen, Zahnfleisch ging zurück und legte Zahnhälse frei, viele CONDITION Zahnarzt-Besuche, habe Topiramat auf 1 x 25mg reduziert, hatte das Problem 2011 schon unter II. SUSPECT DRUG(S) INFORMATION 14. SUSPECT DRUG(S) (include generic name) (cont.) 20. DID REACTION ABATE AFTER STOPPING DRUG? topamax
¨
þ
15. DAILY DOSE(S)
16. ROUTE(S) OF ADMINISTRATION
25 Mg milligram(s)
Oral
17. INDICATION(S) FOR USE
¨ YES ¨ NO ¨ NA 21. DID REACTION REAPPEAR AFTER REINTRODUCTION?
¨ YES ¨ NO ¨ NA
18. THERAPY DATES (from/to)
19. THERAPY DURATION
from 03-FEB-2017 to 09-FEB-2017
7 Day III. CONCOMITANT DRUG(S) AND HISTORY
22. CONCOMITANT DRUG(S) AND DATES OF ADMINISTRATION (exclude those used to treat reaction)
(cont.)
l-thyroxin seit langem - b.a.w. torem Dosis unklar
23. OTHER RELEVANT HISTORY (e.g. diagnostics, allergics, pregnancy with last month of period, etc.)
[ MedDRA 20.0 (10004908): Bipolar affective disorder ] [ MedDRA 20.0 (10004908): Bipolar affective disorder ] [ MedDRA 20.0 (10021642): Incontinence of urine ]
(cont.)
Continuing: Unknown Continuing: Unknown Continuing: Yes
IV. SENDER INFORMATION 24a. NAME AND ADRESS OF SENDER
AMSP - Institut für Arzneimittelsicherheit in der Psychiatri Carl-Neuberg Str. 1 30625 Hannover, DE 24b. MFR CONTROL NO.
DE-BFARM-17174538 24c. DATE RECEIVED BY MANUFACTURER
22-MAY-2017 DATE OF THIS REPORT
30-MAY-2017
24d. REPORT SOURCE
¨ STUDY ¨ LITERATURE þ HEALTH PROFESSIONAL 25a. REPORT TYPE
¨ INITIAL þFOLLOW UP ¨ FINAL (Cont.) = Continuation on attached sheet(s)
AMSP - Institut für Arzneimittelsicherheit in der Psychiatri Carl-Neuberg Str. 1 30625 Hannover, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17174538
7. + 13. Describe Reaction(s) (including relevant tests/lab data)
30-MAY-2017 2 of 8
(... continuation ...)
Cymbalta. Topiramat senkt außerdem Wirkung von Vesicur (das die Wasserbildung einschränke), das Wasser fließe nur so. Begründung des Wahrscheinlichkeitsgrads: Die Zahnfleischproblematik bei der disponierten Pat. kam über die starke Mundtrockenheit unter Topamax zustande und ist in der Fachinfo nicht so beschrieben (nur die Übelkeit). Deutlicher zeitlicher Zusammenhang, abklingen nach Absetzen = > W2, da Mundtrockenheit als häufige UAW bekannt. Vesicur wirkte nicht mehr: lt. mediQ: Klinisch relevante Induktion bei CYP3A: Topiramat macht Plasmaspiegelsenkung von Solifenacin, das wirkt nicht mehr gegen die Inkontinenz. Maßnahmen nach der UkW: Absetzen; Konsil Absetzen von Topamax; Konsil: Zahnarztbehandlung: am 17.02.2017: Zahnarzt pinselte Zahnfleischtaschen. Verlauf:UAW im Abklingen Weiterbehandlung: Einstellung auf Zeldox 2 x 20 mg, darunter noch sehr unruhig, nachts aktiv, hypoman, jetzt auf 2 x 40 mg erhöht. Mögliche Risikofaktoren: ja; UAW-Empfindlichkeit Unter Lithium 20 kg Gewichtszunahme, Stimmung gut, weniger Schmerzen; unter AD UAW oder Gewichtszunahme; Paroxetin - nicht vertragen; Abilify - unruhig, schlechter geschlafen, Rückenschmerzen, unerträglich, nicht einmal Spritzen halfen; unter Valproat 500vmg - Müdigkeit. Duloxetin 2011 - Mundtrockenheit, Zahnfleischbluten
Results of tests and procedures relevant to the investigation of the patient: keine Laborwerte
Reaction text as reported MedDRA coding
Duration
[MedDRA 20.0 PT (10013781): Dry mouth ]
Outcome* Term highlighted
Time interval 1** Time interval 2*** Start date
recovering/resolving
FEB-2017
recovering/resolving
17-FEB-2017
recovering/resolving
FEB-2017
recovering/resolving
FEB-2017
recovered/resolved
FEB-2017
[ MedDRA 20.0 LLT (10013781): Dry mouth ] [MedDRA 20.0 PT (10018290): Gingival recession ] [ MedDRA 20.0 LLT (10018290): Gingival recession ] [MedDRA 20.0 PT (10049870): Tongue haemorrhage ] [ MedDRA 20.0 LLT (10049870): Tongue haemorrhage ] unter 50 mg Topamax Übelkeit morgens [MedDRA 20.0 PT (10028813): Nausea ] [ MedDRA 20.0 LLT (10028813): Nausea ] [MedDRA 20.0 PT (10044055): Toothache ] [ MedDRA 20.0 LLT (10044055): Toothache ]
End date
AMSP - Institut für Arzneimittelsicherheit in der Psychiatri Carl-Neuberg Str. 1 30625 Hannover, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17174538
[MedDRA 20.0 PT (10013781): Dry mouth ]
recovering/resolving
30-MAY-2017 3 of 8
17-FEB-2017
[ MedDRA 20.0 LLT (10013781): Dry mouth ] * 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
Duration
topamax
03-FEB- 09-FEB- 7 Day 2017 2017
Dose *
Route(s) of Administration
A: B: C: 25Mg milligram(s) D: E:
Oral
Identification of the country where the drug was obtained
Deutschland
Name of holder/applicant
Janssen
Indication(s)
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 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 topiramate Causality assessment Reaction
Source
Method
Result
[ MedDRA 20.0 (10013781): Dry mouth ]
AMSP
Global Introspection (WHO GI) probable/likely
AMSP - Institut für Arzneimittelsicherheit in der Psychiatri Carl-Neuberg Str. 1 30625 Hannover, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17174538
[ MedDRA 20.0 (10018290): Gingival recession ]
AMSP
14. Suspect Drug(s) (including generic name)
30-MAY-2017 4 of 8
Global Introspection (WHO GI) probable/likely
(... continuation ...)
Suspect Drug and batch no.
Start date
End date
Duration
topamax
10-FEB- 20-MAR- 39 Day 2017 2017
Dose *
Route(s) of Administration
A: 50 - 25 mg B: C: D: E:
Oral
Indication(s)
Deutschland
Identification of the country where the drug was obtained Name of holder/applicant Authorization/Application Number
Deutschland
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
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 topiramate Causality assessment Reaction
Source
Method
[ MedDRA 20.0 (10013781): Dry mouth ]
AMSP
Global Introspection (WHO GI) certain
[ MedDRA 20.0 (10018290): Gingival recession ]
AMSP
Global Introspection (WHO GI) probable/likely
14. Suspect Drug(s) (including generic name) Suspect Drug and batch no. vesikur
Start date
End date
Result
(... continuation ...) Duration
Dose *
Route(s) of Administration
A: seit langem Oral b.a.w. B: C: 5Mg milligram(s) D: E: 1Day
Indication(s)
AMSP - Institut für Arzneimittelsicherheit in der Psychiatri Carl-Neuberg Str. 1 30625 Hannover, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17174538
30-MAY-2017 5 of 8
Deutschland
Identification of the country where the drug was obtained 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 Urologika
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 solifenacin succinate Causality assessment Reaction
Source
Method
Result
[ MedDRA 20.0 (10018290): Gingival recession ]
AMSP
possible
[ MedDRA 20.0 (10013781): Dry mouth ]
AMSP
possible
22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.
Start date
End date
l-thyroxin
Duration
Dose * A: seit langem b.a.w. B: C: 175µg microgram(s) D: E: 1Day
Identification of the country where the drug was obtained
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
Deutschland
(... continuation ...)
Route(s) of Administration Oral
Indication(s) Thyroid disorder
AMSP - Institut für Arzneimittelsicherheit in der Psychiatri Carl-Neuberg Str. 1 30625 Hannover, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17174538
30-MAY-2017 6 of 8
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: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name levothyroxine sodium 22. Concomitant Drug(s) and Dates of Administration (exclude those used to treat reaction) Concomitant Drug and batch no.
Start date
End date
torem
Duration
Dose * A: Dosis unklar B: C: D: E:
Identification of the country where the drug was obtained
(... continuation ...)
Route(s) of Administration Oral
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 Additional information on drug
Anwendung seit langem
Did reaction reappear after reintroduction? * A: Dosage Text B: Cululative dose number (to first reaction) C: Structure of separate dosages D: Number of separate dosages E: Number of units in the interval Active drug substance name torasemide 23. Other relevant history
(... continuation ...)
Reactions, Symptoms and Events
Start date End date Continuing Comments
Indication(s)
AMSP - Institut für Arzneimittelsicherheit in der Psychiatri Carl-Neuberg Str. 1 30625 Hannover, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17174538
30-MAY-2017 7 of 8
[ MedDRA 20.0 (10004908): Bipolar affective disorder ]
Unknown
Bipolare affektive Störung, gegenwärtig gemischte Episode
[ MedDRA 20.0 (10021642): Incontinence of urine ]
Yes
Harninkontinenz seit Kindheit
[ MedDRA 20.0 (10001293): Adiposis ]
Unknown
Adipostas Grad II
[ MedDRA 20.0 (10027599): Migraine ]
Unknown
Migräne, nicht näher bezeichnet
[ MedDRA 20.0 (10055577): Obstructive sleep apnea syndrome ] [ MedDRA 20.0 (10077221): Hypothyreosis ]
Report duplicates Duplicate source
Duplicate number
AMSP - Institut für Arzneimittelsicherheit in der
teu-02-101a
AMSP - Institut für Arzneimittelsicherheit in der
TEU-02-101A
Patient past drug therapy Name of drug as reported
Indication MedDRA code
Reactions MedDRA code
cymbalta
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10013781): Dry mouth ]
cymbalta
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10044055): Toothache ]
cymbalta
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10018290): Gingival recession ]
lithium
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10047896): Weight gain ]
valproat
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10043890): Tiredness ]
abilify
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10038743): Restlessness ]
abilify
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10013268): Disorder sleep ]
abilify
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10003988): Back pain ]
paroxetin
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10061822): Drug intolerance ]
lithium
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10043890): Tiredness ]
duloxetin
[ MedDRA 20.0 (0): unbekannt ]
[ MedDRA 20.0 (10018276): Gingival bleeding ]
ADMINISTRATIVE AND IDENTIFICATION INFORMATION
Safetyreportversion
1
Start date End date
AMSP - Institut für Arzneimittelsicherheit in der Psychiatri Carl-Neuberg Str. 1 30625 Hannover, DE
Continuation sheet for CIOMS report Report Date: Report Page:
DE-BFARM-17174538
Identification of the country where the reaction/event occur
Deutschland
Serious
Yes
Date Format of receipt of the most recent information for this report
20170522
Additional documents
No
30-MAY-2017 8 of 8
List of documents held by sender Does this case fulfill the local criteria for an expedited report?
Yes
Regulatory authority's case report number Other case identifiers in previous transmissions
Yes
Was the case medically confirmed, if not initially from health professional?
No
Primary source(s) of information Study name Reporter postcode Reporter country
Qualification
15
Physician
Deutschland
Literature reference(s)
Sponsor study number
SENDER INFORMATION (... continuation ...) Type
Health professional
Organisation
AMSP - Institut für Arzneimittelsicherheit in der Psychiatri
Department Street address
Carl-Neuberg Str. 1
City
Hannover
Postcode
30625
Country
Deutschland
Fax Telephone E-mail address 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
Adult
>18.Lj. bis einschl. 65.Lj.
Study type in which the reaction(s)/event(s) were observed
