Open Journal of Safety Science and Technology, 2011, 1, 60 -74
doi:10.4236/ojsst.2011.12006 Published Online September 2011 (http://www.SciRP.org/journal/ojsst)
Adverse Drug Reactions Reported in the German
Democratic Republic: A Retrospective Analysis of
Reports to the WHO-ADR Database
Lise Aagaard1,2,3, Marion Schaefer4, Ulrich Meyer5, Ebba Holme Hansen1,2,3
1Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy,
Faculty of Pharmaceutical Sciences, University of Copenhagen, Copenhagen, Den mark
2FKL-Research Centre for Quality in Medicine Use, Copenhagen, Denmar k
3Danish Phar macovigila nce Research pro j ect (DANPREP), Copenhagen, Denm ark
4Institut für Klinische Pharmakologie, Charitè University Medicine, Berlin, Germany
5Institut für Pharmazie, Ernst Moritz Arndt University, Greifswald, Germany
Received June 11, 2011; revised July 22, 2011; accepted August 2, 2011
Abstract
The German Democratic Republic (GDR) joined the WHO collaboration on drug safety in 1983 in order to
strengthen their national pharmacovigilance system. We aim to characterize adverse drug reaction (ADR)
reports which were forwarded to the WHO-ADR database by the GDR health authorities, as these data is
unknown to the public. ADR reports were analysed with respect to time, type of reporter, age and sex of the
patient, category of ADR (System Organ Class [SOC]), seriousness and suspected medicines. The unit of
analysis was one ADR. A total of 180 individual ADR reports covering 329 ADRs were forwarded from
1985 to 1990. The largest share of ADRs was reported for psychotropic medicines (23% of total ADRs) fol-
lowed by anti-infectives for systemic use (19% of ADRs), and medicines for the cardiovascular system (16%
of ADRs). The largest share of reported ADRs was from the SOC “hepatobiliary disorders” (16% of total
ADRs), followed by the SOCs “skin and subcutaneous disorders” (14% of total ADRs) and “blood and lym-
phatic disorders” (11% of total ADRs). Approximately 10% of ADRs were serious and included fatal cases.
In conclusion, only a limited number of ADR cases occurring in the former GDR, the majority being non-
serious, were located in the WHO database. However from government files we know that a large number of
serious and fatal ADRs were reported, but information about these were never communicated to the public.
Keywords: Pharmacovigilance, Spontaneous Reporting Systems, VigiBase, German Democratic Republic
1. Introduction
During the 1960s, in the wake of the thalidomide catas-
trophe in the late 1950s [1], pharmacovigilance systems
were established in many western European countries,
Canada and Australia [2]. The World Health Organiza-
tion (WHO) established an international reporting system
in 1968 and over the years an ever-increasing number of
countries have joined this collaboration [3]. In the second
half of the 20th century, a separate pharmaceutical policy
system was established in the previous Council for Mu-
tual Economic Assistan ce (Comecon) countries, but little
is known to the public about the principles of this system.
The German Democratic Republic (GDR) was well-
known for its large production of pharmaceuticals, often
copies of medications developed by pharmaceutical
companies in capitalistic countries, produced in large
state-owned companies which supplied the other Come-
con members [4]. New medicines were introduced years
later in the GDR than in western European countries, and
due to safety reasons thalidomide was never marketed in
the GDR. Medicines safety was of great importance to
the East German politicians and to increase medicines
safety in the GDR, a national ADR reporting system was
established in 1964 [4-5]. Limited information about data
reported to this system was communicated to the pre-
scribers and patients, as such type of information was
considered as being a state secret and only available to

L. AAGAARD ET AL. 61
people working with drug regulation. Available product
information and/or patient leaflets were of very limited
quality or non-existing and difficult to get access to, as
these documents were only produced in a limited number
of copies [4].
Internal documents from the GDR health authorities
revealed that from 1981 to 1983 spontaneous reports
covering information about more than 120 deaths from
use of anti-rheumatic medications containing indome-
tacin (Metindol/Amuno), diclofenac (Rewodina), phenyl-
butazone (Butaz olidin ), aminophenazone + phenylbuta-
zone (Wofapyrin) and the antidiarrheal Mexaform plus
(phanquinon + dichlorhydroxychinolin) and dichlorhy-
droxychinolin (Endiaron) existed, but no restrictions for
the use of these products were made [4]. For the X-ray
contrast agent iomeglamic acid (Falignost) several seri-
ous cases of allergies and anaphylactic shocks were re-
ported which led to changes in the production, as radio-
graphic examination were frequently used as a diagnostic
method in the GDR [4].
Of political reasons the GDR were not able to join the
international WHO collaboration on medicines safety
until 1983, despite that other Comecon countries such as
Bulgaria, the Czech Republic, Poland and Romania had
already joined this collaboration in the 1970s. From 1985
until the German reunification in 1990, ADR reports
were forwarded to the WHO ADR database, VigiBase by
the GDR health authorities [4,6-7].
We aim to characterize these ADRs reports, as these
data has never been published before, and therefore
would be of interest to the public.
2. Methods
2.1. Design
We retrospectively analysed all ADR reports occurring
in the GDR which were reported to VigiBase from July
1985 to May 1990. ADR data were placed at the disposal
of this study in anonymous form with encrypted identi-
fication of the medicine user. ADR reports were pro-
vided by the Uppsala Monitoring Centre (UMC) as
CIOMS reports, and data from these reports were manu-
ally entered into Microsoft Excel. The unit of analysis
was one ADR.
We analysed the reports with regard to type of reporter,
age and gender of the patient, type (system organ class
[SOC]) and seriousness of reported ADRs with respect to
medications involved.
2.2. Seriousness and Causality Criteria
The severity of ADRs was rated as certain, probable or
possible according to the CIOMS scale [1]. Causality
was rated as established, probable, possible, improbable
and not to be ascertained. Reports were later classified as
being serious or non-serious according to international
criteria.
2.3. Classification of reported ADRs
Any ADRs reported were classified according to the in-
ternational classification system Medicinal Dictionary
for Regulatory Activities (MedDRA) by preferred term
(PT) and (SOC) [8].
2.4. Setting
A national ADR reporting system was established in
1964 by law by the GDR’s Ministry of Health [5]. The
system was managed by the “Institut für Arzneimittel-
wesen der DDR” (IfAr), and physicians and pharmacists
were required to report ADRs [4-5].
An official reporting form (“Meldung von Schädlichen
Arzneimittelwirkungen”) had to be completed, and the
following information was required: age and gender of
the patient; severity and characteristics of the ADR(s),
suspected and concomitant medicines, indication for use,
dosage, treatment period, date of onset of ADR, causality
assessment and other relevant information such as labo-
ratory data if available (internal documents).
2.5. Medicine Use in the GDR
Medicines licensed for use in the GDR were listed in the
“Arzneimittel Verzeichnis”, published periodically by
the IfAr and containing information about the active
ingredients of available medicines, dosage, warnings,
ADRs and contra-indications [6]. From 1945 to 1990
approximately 1770 different types of medicines (pres-
cription medicine, over-the-counter medicine, comple-
mentary medicine, herbals, homeopathic medicine, aller-
gen extracts, blood products and radioactive medications)
were licensed for use in the GDR [7]. The number and
assortment varied over time. In the same period, up to
57,000 different pharmaceutical products were licensed
for use in West Germany [7]. In the beginning of the
1960s, the number of medicines imported into the GDR
constituted 5% of all licensed medicines in the GDR, but
this share increased up to approximately 30% of all
licensed medicine in 1989/1990 [6]. The imported me-
dicines were produced by pharmaceutical companies
located in COMECON member states (estimated 20%)
or in Western European countries (estimated 10%), and
imported in the GDR by the special office/pharmacy:
“Beratungsbüro für Arzneimittel”, which worked for the

L. AAGAARD ET AL. 62
GDR Ministry of Health. Medicines imported from
Western countries had to be paid with Western curren-
cies, therefore the import was limited, and the aim was in
most cases to substitute in the future with GDR or
COMECON production [6]. Prescription medicines were
free in the GDR, and over-the-counter medicines were
inexpensive. Medicine prices were fixed by the state, and
rarely changed from 1945 to 1990 [6].
3. Results
In total 180 individual ADR reports covering 329 ADRs
were reported from 1985 to 1990. The ADR reports were
of high quality and very detailed with information about
causality assessment and reaction outcome. Approxi-
mately 10% of reported ADRs were serious and 13 fatal
cases were located (Table 1), however these ADRs were
all known ADRs. Two-thirds of the total ADRs were
reported by hospital physicians, 23% of ADRs by gen-
eral practitioners and 12% of ADRs were reported by
specialist physicians. Serious ADRs were only reported
by hospital physicians. No ADRs were reported by
pharmacists.
3.1. ADRs by Age and Sex
The majority of reported ADRs (88% of total) occurred
in adults, followed by 6% of ADRs reported in children
from ages 3 to 10. Less than six percent of ADRs was
reported in children up to two years of age and in ado-
lescents (ages 11 - 17). Forty percent of ADRs was re-
ported for males and sixty percent of ADRs for females.
3.2. ADRs by Type and Seriousness
The largest share of reported ADRs was from the SOC
“hepatobiliary disorders” (16% of total ADRs), followed
by the SOCs “skin and subcutaneous disorders” (14% of
total ADRs) and “blood and lymphatic disorders” (11%
of total ADRs).
3.3. ADRs by Medication
Less than 10% of ADRs were reported for medications
imported from non-socialistic countries. The largest
share of ADRs was reported for psychotropic medicines
(23% of total ADRs) followed by anti-infectives for sys-
temic use (19% of ADRs), and medicines for the cardio-
vascular system (16% of ADRs).
4. Discussion
This is the first study to retrospectively analyse sponta-
neous ADR reports from the former German Democratic
Republic submitted to the WHO-ADR database. From
1985 to 1990 only a selected number of ADR reports
Table 1. Characteristics of serious adverse drug reactions le ading to death reported to Vigibase, Ger man Democratic Repub-
lic, 1985-1990.
Case no. Year ATC group Medicine Active substanceAdverse drug reaction (ADR)Indication GenderAge (year)
1 1985 M01AB05 Rewodina Diclofenac Pancytopenia Spondolysis Female64
2 1988 P01BD01 Tindurin Pyrimethamine Agranulocytosis Perinatal condition Male 1
3 1988 N02BB02 Analgin Metamizole/lidocainAgranulocytosis Nasopharyngitis Male 49
4 1988 J01ED07 Mebacid Sulfamerazine Epidermal necrolysis Chronic bronchitis Female61
5 1988 J01BA01 Berlicetin Chloramphenicol Marrow depression Chronic bronchitis Female49
7 1989 J01CA01 Ampicillin Ampicillin Anaphylactic shock Chronic bronchitis Female52
8 1989 M01AA06 Ketazone Kebuzone Purpura
Thrombocytopenia Effusion of joint Female74
9 1988
N02BB04
M01AA06
Eufibron
Ketazone
Propyphenazone
Kebuzone
Disseminated intravascular
coagulation
Marrow depression
Cardiomyopathy
NA Male 17
10 1989 P01AB01 Clont Metronidazole Anaphylactic shock NA Female51
11 1990 V08AA01 Visotrast Amidotrizoic acidAnaphylactic shock Hydronephrosis Male 68
12 1990 M03CA01 Pavulon Pancuronium Bradycardia
Cardiac arrest NA Male 5 mo.
13 1990 N05AH02 Alemoxan Clozapine Agranulocytosis NA Male 50
NA: not *vailable; mo: months.

L. AAGAARD ET AL. 63
were forwarded to VigiBase despite that around 400 to
500 ADR reports were reported annually to the GDR
health authorities [4]. The low number of reports sub-
mitted to VigiBase was due to the fact that when the
GDR joined the WHO collaboration the IfAr decided
that only unknown and severe ADRs should be reported
to VigiBase. The ADR reports located in VigiBase were
in line with observations from other western European
countries with respect to type and suspected medication
[9-10]. Few serious cases were reported, however cau-
sality was only established in three cases. Only a small
number of serious ADRs was reported in the GDR,
however, several cases of hepatitis and anaphylactic
shock were classified as non-serious although causality
was rated as being certain or possible. In the cases of
anaphylactic shock the reported medicines were often
administered intravenously (IV) or subcutaneously (SC).
Only one case of pancytopenia reported for diclofenac
was located despite that many other serious ADR cases
were reported in the 1970s and 1980s [4].
As we only have ADR data from the last six years of
the existence of the GDR, it was not possible to conduct
a time trend analysis. The UMC could not guarantee that
the actual number of ADR reports from the GDR au-
thorities had been higher, but reports included in this
study only represent those reported to VigiBase. In gen-
eral, the ADR reports were of high quality and thorough,
but due to their low number, they only represent a lim-
ited number of the ADRs which eventually occurred in
the former GDR. To explore whether a greater number of
ADRs was reported elsewhere in East Germany, one
would need access to the archives from the former East
Germany.
5. Conclusions
Only selected information about ADRs occurring in the
former GDR was located in the WHO database. However
from government files we know that a large number of
serious and fatal ADR cases were reported to national
authorities, but information was never communicated to
the patients or prescribers.
6. References
[1] E. B. Andrews and R. D. Mann, “Pharmacovigilance,”
2nd Edition, John Wiley & Sons, Chichester, 2007.
[2] W. H. Wardell, G. P. Velo and N. M, Jarocha, “Drug
Development, Regulatory Assessment and Post Market-
ing Surveillance,” Plenum, New York, 1981.
[3] S. Olsson, “The Role of the WHO Programme on Interna-
tional Drug Monitoring in Coordination Worldwide Drug
Safety Efforts,” Drug Safety, Vol. 19, No. 1, 1998, pp.
1-10. doi:10.2165/00002018-199819010-00001
[4] Ministerium für Gesundheitswesen. Arbeitsgruppe für
Organisation und Inspektion beim Ministerrat, Kontrolab-
teilung. Bericht über Stand und erforderliche Massnah-
men zur weiteren Erhöhung der Arzneimittelsicherheit in
der DDR. Pharmazie und Technik. Berlin, 1984.
[5] J. Richter and M. Wolski, “40 Jahre Regelung und
Überwa Chung des Arzneitmittelverkehrs in der Deuts-
chen Demokratischen Republik,” Pharmazie, Vol. 44, No.
10, 1989, pp. 666-671.
[6] M. Bőhm, K. Gerccke, L. Kny, H. Probst and J. Richter,
45 Jahre Pharmazie in Deutschland Ost. 7bDirekt Apo-
thekenservice AG, Fürstenfeldbruck, Berlin, 2007.
[7] J. Richter, H. J. Seidelin, M. Böhm, H. G. Keune and E.
Gueinzius, “Arzneimittel-und Apothekenrecht der
Republic,” Akademie-Verlag, Berlin, 1985.
[8] The Medical Dictionary for Regulatory Activities
(MedDRA). http://www.meddramsso.com
[9] L. Aagaard, L. H. Nielsen and E. H. Hansen, “Consumer
Reporting of Adverse Drug Reactions: A Retrospective
Analysis of the Danish Adverse Drug Reaction Database
from 2004 to 2006,” Drug Safety, Vol. 32, No. 11, 2009,
pp. 1067-1074. doi:10.2165/11316680-000000000-00000
[10] J. de Langen, F. van Hunsel, A. Passier, L. de Jong-van
den Berg, K. van Grootheest, “Adverse Drug Reaction
Reporting by Patients in the Netherlands: Three Years of
Experience,” Drug Safety, Vol. 31, No. 6, 2008, 515-524.
doi:10.2165/00002018-200831060-00006

L. AAGAARD ET AL. 64
Supporting Information
Additional supporting information may be found in the online version of this article in Table S1.
Table S1. Characteristics of adverse drug reaction reports from the German Democratic Republic (GDR) to Vigibase, 1985 to
1990.
Case
no. Year ATC Medicine Manufacturer Active substance
Adverse
drug reaction SeriousIndication GenderOutcome Causality Dose Admin.ReporterAge (years)
1 1985 H02AB06 Prednisolut GDR Prednisolon Bradycardia No Bronchitiss MaleRecovered Certain 25 mg IV Hospital59
1985 H02AB06 Prednisolut GDR Prednisolon Apnoea No Bronchitis MaleRecovered Certain 25 mg IV Hospital59
1985 H02AB06 Prednisolut GDR Prednisolon Anaphylactic
shock No Bronchitis MaleRecovered Certain 25 mg IV Hospital59
2 1986 N05CM02 Distraneurin AstraZeneca Clomethiazole Hypotonia No Psychoses MaleRecovered Certain 3 DF OralHospital46
1986 N05CM02 Distraneurin AstraZeneca Clomethiazole Bradycardia No Psychoses MaleRecovered Certain 3 DF OralHospital46
s 1986 N05CM02 Distraneurin AstraZeneca Clomethiazole Circulatory
failure No Psychoses MaleRecovered Certain 3 DF OralHospital46
1986 N05CM02 Distraneurin AstraZeneca Clomethiazole Anaphylactic
shock No Psychoses MaleRecovered Certain 3 DF OralHospital46
3 1986 C05BX01 Calcium
dobesilate GDR Calcium dobesilate Fever No
Retinal
disorders Female NA Probable 750 mg OralSP 71
4 1986 N05AD01 Haloperidol Hungary Haloperidol Palpitation No Psychoses FemaleRecovered Certain 3 mg OralGP 10
1986 N05AD01 Haloperidol Hungary Haloperidol Somnolence No Psychoses FemaleRecovered Certain 3 mg OralGP 10
1986 N05AD01 Haloperidol Hungary Haloperidol Dyskinesia
tardive No Psychoses FemaleRecovered Certain 3 mg OralGP 10
1986 N05AD01 Haloperidol Hungary Haloperidol Anxiety No Psychoses FemaleRecovered Certain 3 mg OralGP 10
5 1986 N03AB02 Phenytoin GDR Phenytoin Nausea No Epilepsy FemaleRecovered Possible 300 mg OralGP 45
1986 C02AB01 Dopegyt Hungary Methyldopa Ataxia No Hypertension FemaleRecovered Possible 300 mg OralGP 45
1986 C02AB01 Dopegyt Hungary Methyldopa Diplopia No Hypertension FemaleRecovered Possible 300 mg OralGP 45
6 1986 N03AF01 Finlepsin GDR Carbamazepine Rash maculo-papularNo Trigeminal
nerve disorder FemaleRecovered Certain 400 mg OralSP 61
7 1987 J01XE01 Nitrofurantin GDR Nitrofurantoin Alveolitis
allergic No Urinary tract infection FemaleRecovered Certain NA OralGP 70
1987 J01XE01 Nitrofurantin GDR Nitrofurantoin Fever No Urinary tract
infection FemaleRecovered Certain NA OralGP 70
8 1987 C02AB01 Dopegyt Hungary Methyldopa Fever No Hypertension MaleRecovered Certain 500 mg OralHospital59
9 1988 M01AB05 Rewodina GDR Diclofenac Anaphylactic shockNo Cervical
spondylosis FemaleRecovered Possible 2 DF OralHospital 55
1988 M01AB05 Rewodina GDR Diclofenac Bronchospasm No Cervical
spondylosis FemaleRecovered Possible 2 DF OralHospital 55
10 1989 H02AB06 Prednisolut GDR Prednisolon Anaphylactic shockNo Myeloid
leukaemia Female Recovered w. sequaelae Certain 100 mg IV SP 54
1989 H02AB06 Prednisolut GDR Prednisolon Cardiac arrest No Myeloid
leukaemia Female Recovered w. sequaelae Certain 100 mg IV SP 54
1989 H02AB06 Prednisolut GDR Prednisolon Apnoea No Myeloid
leukaemia Female Recovered w. sequaelae Certain 100 mg IV SP 54
11 1989 A07EC01 Sulfasalazine Yugoslavia Sulfasalazine Hepatic necrosis No Ulcerative
colitis Male Recovered w. sequaelae Certain 8 DF OralHospital48
1989 A07EC01 Sulfasalazine Yugoslavia Sulfasalazine Hepatitis No Ulcerative
colitis Male Recovered w. sequaelae Certain 8 DF OralHospital48
12 1989 A02BA01 Altramet GDR Cimetidine Alopecia No Duodenal ulcer MaleRecovered Probable 800 mg OralHospital30
13 1989 J01XE01 Nifurantin GDR Nitrofurantoin Bronchospasm No Pyelonephritis MaleRecovered Certain 200 mg OralHospital35

L. AAGAARD ET AL. 65
1989 J01XE01 Nifurantin GDR Nitrofurantoin Cyanosis No Pyelonephritis MaleRecovered Certain 200 mg OralHospital35
1989 J01XE01 Nifurantin GDR Nitrofurantoin Coughing No Pyelonephritis MaleRecovered Certain 200 mg OralHospital35
1989 J01XE01 Nifurantin GDR Nitrofurantoin Fever No Pyelonephritis MaleRecovered Certain 200 mg OralHospital35
14 1989 D10AX05 Avlosulfon Wyeth-Ayerst Dapsone Anaemia
haemolytic No Erythematous conditions FemaleRecovered Certain 2.5 DF OralHospital33
1989 D10AX05 Avlosulfon Wyeth-Ayerst Dapsone Conjunctivitis No Erythematous
conditions FemaleRecovered Certain 2.5 DF OralHospital33
1989 D10AX05 Avlosulfon Wyeth-Ayerst Dapsone MethaemoglobinaemiaNo Erythematous
conditions FemaleRecovered Certain 2.5 DF OralHospital33
1989 D10AX05 Avlosulfon Wyeth-Ayerst Dapsone Sgpt increased No Erythematous
conditions FemaleRecovered Certain 2.5 DF OralHospital33
1989 D10AX05 Avlosulfon Wyeth-Ayerst Dapsone Sgot increased No Erythematous
conditions FemaleRecovered Certain 2.5 DF OralHospital33
15 1989 N06BX01 Cerutil GDR Meclofenoxate Arrhytmia No Stress MaleRecovered Certain 300 mg OralGP 54
1989 N06BX01 Cerutil GDR Meclofenoxate Headache No Stress MaleRecovered Certain 300 mg OralGP 54
16 1985 M01AB05 Rewodina GDR Diclofenac Pancytopenia YesSpondolysis FemaleDied Possible 50 mg OralHospital64
1985 M01AB05 Rewodina GDR Diclofenac Death YesSpondolysis FemaleDied Possible 50 mg OralHospital64
17 1988 P01BD01 Tindurin Hungary Pyrimethamine Agranulocytosis YesPerinatal
condition MaleDied Certain 450 mg OralHospital1
1988 P01BD01 Tindurin Hungary Pyrimethamine Death YesPerinatal
condition MaleDied Certain 450 mg OralHospital1
18 1988 N02BB02 Analgin GDR Metamizole/
lidocain Agranulocytosis YesNasopharyngitisMaleDied Possible 14 g OralHospital49
1988 N02BB02 Analgin GDR Metamizole/
lidocain Death YesNasopharyngitisMaleDied Possible 14 g OralHospital49
19 1988 J01ED07 Mebacid GDR Sulfamerazine Epidermal
necrolysis YesBronchitis FemaleDied Probable 1 g OralHospital61
1988 J01ED07 Mebacid GDR Sulfamerazine Death YesBronchitis FemaleDied Probable 1 g OralHospital61
20 1988 J01BA01 Berlicetin GDR Chloramphenicol Marrow
depression YesBronchitis FemaleDied Probable 2g OralHospital49
1988 J01BA01 Berlicetin GDR Chloramphenicol Death YesBronchitis FemaleDied Probable 2g OralHospital49
21 1989 J01CA01 Ampicillin Bulgaria Ampicillin Anaphylactic shockYesBronchitis Female Died Probable 4g IV Hospital52
1989 J01CA01 Ampicillin Bulgaria Ampicillin Death YesBronchitis FemaleDied Probable 4g IV Hospital52
22 1989 M01AA06 Ketazon CSSR Kebuzone Purpura YesEffusion of jointFemaleDied Certain 0.5 g OralHospital74
1989 M01AA06 Ketazon CSSR Kebuzone Thrombocytopenia YesEffusion of jointFemaleDied Certain 0.5 g OralHospital74
1989 M01AA06 Ketazon CSSR Kebuzone Death YesEffusion of jointFemaleDied Certain 0.5 g OralHospital74
23 1988 M01AA06 Ketazon CSSR Kebuzone Death YesNA MaleDied Probable NA OralHospital17
1988 N02BB04 Eufibron GDR Propyphenazone Dic YesNA MaleDied Probable NA OralHospital17
1988 N02BB04 Eufibron GDR Propyphenazone Marrow
depression YesNA MaleDied Probable NA OralHospital17
1988 N02BB04 Eufibron GDR Propyphenazone Cardiomyopathy YesNA MaleDied Probable NA OralHospital17
24 1989 P01AB01 Clont Bayer Metronidazole Anaphylactic shockYesNA FemaleDied Probable 500 mg IV Hospital51
1989 P01AB01 Clont Bayer Metronidazole Death YesNA FemaleDied Probable 500 mg IV Hospital51
25 1990 V08AA01 Visotrast GDR Amidotrizoic
acid Anaphylactic shockYesHydronephrosis MaleDied Certain 35 ml IV Hospital68

L. AAGAARD ET AL. 66
1990 V08AA01 Visotrast GDR Amidotrizoic
acid Death YesHydronephrosis MaleDied Certain 35 ml IV Hospital68
26 1990 N05AH02 Alemoxan GDR Clozapine Agranulocytosis YesNA MaleDied Probable 200 mg OralHospital50
27 1985 N05AH02 Clozapine Novartis Clozapine Agranulocytosis No Schizophrenia MaleRecovered Certain 250 mg OralHospital49
1985 N05AH02 Clozapine Novartis Clozapine Fever No Schizophrenia MaleRecovered Certain 250 mg OralHospital49
1985 N05AH02 Clozapine Novartis Clozapine Rash erythematous No Schizophrenia MaleRecovered Certain 250 mg OralHospital49
28 1985 C02DB01 Obsilazin GDR Propranolol/
dihydralazin Hepatitis necrosis No Hypertension FemaleNA Certain 1.5 DF OralHospital52
1985 C02DB01 Obsilazin GDR Propranolol/
dihydralazin Hepatitis No Hypertension FemaleNA Certain 1.5 DF OralHospital52
29 1986 M01AE01 Ibuprofen Poland Ibuprofen Haematuria No Pain FemaleRecovered Probable 600 mg OralGP 35
30 1986 M01AA06 Ketazon CSSR Kebuzone Hepatitis No
Ankylosing
spondylitis Female NA Probable 1.5 g OralHospital46
31 1986 J01X E01 Nitrofurantin GDR Nitrofurantoin Spasm generalized No Cystitis FemaleNA Certain 100 mg OralGP 34
1986 J01X E01 Nitrofurantin GDR Nitrofurantoin Tachycardia No Cystitis FemaleNA Certain 100 mg OralGP 34
1986 J01X E01 Nitrofurantin GDR Nitrofurantoin Hypotension No Cystitis FemaleNA Certain 100 mg OralGP 34
1986 J01X E01 Nitrofurantin GDR Nitrofurantoin Pruritus No Cystitis FemaleNA Certain 100 mg OralGP 34
1986 J01X E01 Nitrofurantin GDR Nitrofurantoin Vomiting No Cystitis FemaleNA Certain 100 mg OralGP 34
32 1986 B05CB10 Infukoll m40 GDR Sodium chloride/
dextran 40 Hypotonia No
Cerebral
ischaemia MaleRecovered Certain 10 ml IV Hospital84
1986 B05CB10 Infukoll m40 GDR Sodium chloride/
dextran 40 Tachycardia No Cerebral ischaemia MaleRecovered Certain 10 ml IV Hospital84
1986 B05CB10 Infukoll m40 GDR
Sodium schlo-
ride/
dextran 40
Anaphylactic shockNo Cerebral
ischaemia MaleRecovered Certain 10 ml IV Hospital84
33 1986 B05CB10 Infukoll m40 GDR Sodium chloride/
dextran 40 Hypotonia No Atherosclerosis FemaleRecovered Probable 250 ml IV Hospital70
1986 B05CB10 Infukoll m40 GDR Sodium chloride/
dextran 40 Dyspnoea No Atherosclerosis FemaleRecovered Probable 250 ml IV Hospital70
34 1986 A03FA01 Cerucal GDR Metoclopramide Depression No Acute gastritis FemaleNA Possible 30 mg OralGP 60
35 1986 N05BA01 Faustan GDR Diazepam Rash erythematous No Cardiovascular
malfunction FemaleRecovered Possible 15mg OralGP 35
36 1986 J01XE01 Nitrofurantin GDR Nitrofurantoin Urticaria acute No Urinary tract
infection FemaleRecovered Certain 100 mg OralGP 35
37 1986 J01EE07 Berlocombin GDR Sulfamerazine
/trimethoprim Pruritus No
Respiratory
infection Female Recovered Probable 4 DF OralGP 42
1986 J01EE07 Berlocombin GDR Sulfamerazine/
trimethoprim
Rash
erythematous No Respiratory infection Female Recovered Probable 4 DF OralGP 42
1986 B05CA01 Trachiform GDR Benzocaine/
cetylpyridinium Pruritus No
Respiratory
infection Female Recovered Probable 6 DF OralGP 42
1986 B05CA01 Trachiform GDR Benzocaine/
cetylpyridinium
Rash
erythematous No Respiratory infection Female Recovered Probable 6 DF OralGP 42
38 1986 J01EE07 Berlocombin GDR Sulfamerazine/
trimethoprim
Rash
erythematous No Respiratory infection Female Recovered Probable 4 DF OralGP 76
39 1986 J01EE07 Berlocombin GDR Sulfamerazine/
trimethoprim
Erythema
exudativum No Respiratory infection MaleRecovered Certain 6DF OralHospital57
40 1986 B05CB10 Infukoll m40 GDR Sodium chloride/
dextran 40 Bronchospasm No Cerebral ischaemia FemaleRecovered Certain 10 ml IV Hospital70
1986 B05CB10 Infukoll m40 GDR Sodium chloride/
dextran 40
Circulatory
failure No Cerebral ischaemia FemaleRecovered Certain 10 ml IV Hospital70
1986 B05CB10 Infukoll m40 GDR Sodium chloride/
dextran 40
Anaphylactic
shock No Cerebral ischaemia FemaleRecovered Certain 10 ml IV Hospital70
41 1986 C02DB01 Depressan GDR Dihydralazine Hepatocellular
damage No Hypertension FemaleRecovered Certain 75 mg OralHospital48

L. AAGAARD ET AL. 67
42 1986 C08CA05 Corinfar GDR Nifedipine Oedema legs No Hypertension MaleRecovered Probable 30 mg OralGP 49
43 1986 C02AB01 Dopegyt Hungary Methyldopa Anaemia
haemolytic No Hypertension MaleNA Probable 2g OralHospital55
44 1986 V03AB14 Protamin GDR Protamin Anaphylactic
shock No Neoplasms FemaleRecovered Certain 45 mg IA NA 33
45 1986 C02DB01 Obsilazin GDR Propranolol/
dihydralazin
Hepatocellular
damage No Hypertension FemaleRecovered Certain 1 DF OralHospital78
1986 C02DB01 Obsilazin GDR Propranolol/
dihydralazin Jaundice No Hypertension FemaleRecovered Certain 1 DF OralHospital78
1986 C02DB01 Obsilazin GDR Propranolol/
dihydralazin Sgot increased No Hypertension FemaleRecovered Certain 1 DF OralHospital78
1986 C02DB01 Obsilazin GDR Propranolol/
dihydralazin Sgpt increased No Hypertension FemaleRecovered Certain 1 DF OralHospital78
1986 C02DB01 Obsilazin GDR Propranolol/
dihydralazin Bilirubinaemia No Hypertension FemaleRecovered Certain 1 DF OralHospital78
46 1986 J04AB02 Rifampicin Romania Rifampicin Thrombocytopenia No Tuberculosis MaleNot
recovered Possible 600 mg OralSP 65
47 1986 A03FA01 Cerucal GDR Metoclopramide Dystonia No Gastritis FemaleRecovered Probable 50 mg OralHospital18
1986 A03FA01 Cerucal GDR Metoclopramide Oculogyric crisis No Gastritis FemaleRecovered Probable 50 mg OralHospital18
1986 A03FA01 Cerucal GDR Metoclopramide Torticollis No Gastritis FemaleRecovered Probable 50 mg OralHospital18
48 1986 M01AB05 Rewodina GDR Diclofenac Anaphylactoid
reaction No Spondylosis FemaleRecovered Probable 25 mg OralGP 54
49 1986 N02BB02 Analgin GDR Metamizole/
Lidocain Agranulocytosis No Respiratory infection MaleRecovered Probable 1.5 DF OralHospital76
50 1986 A01AA01 Koreberon GDR Sodium fluoride Parasthesia No Osteoporosis MaleNot
recovered Possible 60 mg OralGP 49
51 1986 J01XE01 Nitrofurantin GDR Nitrofurantoin
Anaphylactic
shock No Urinary tract infection Female Recovered Probable 100 mg OralHospital54
52
1986 B03AB02 Ferrum-III- Saccharose Bulgaria Ferrum-III- Saccharose
Anaphylactic
shock No Iron deficiency anaemia FemaleRecovered Certain 400 mg IV SP 29
53 1986 M01AA06 Ketazon CSSR Kebuzone Hepatitis
cholestatic No Crystal arthropahy FemaleRecovered Certain 250 mg OralSP 21
54 1986 J01AA02 Doxymycin GDR Doxycycline Hepatocellular damageNo Diseases of
endocardium MaleRecovered Probable 1 DF OralHospital50
55 1986 J04AC01 INH_Tabletten GDR Isoniazid Muscle
atrophy No Pulmonary uberculosis Male Recovered w. sequaelae Probable NA OralSP 45
1986 J04AC01 INH-Tabletten GDR Isoniazid Neuropathy No
Pulmonary
uberculosis Male Recovered w. sequaelae Probable NA OralSP 45
56 1986 A06AB02 Pyrilax GDR Bisacodyl Anaphylactoid reactionNo Constipation FemaleRecovered Probable 10 mg RectalHospital75
57 1986 A06AB02 Pyrilax GDR Bisacodyl Anaphylactoid reactionNo Constipation FemaleRecovered Probable 10 mg RectalHospital61
58 1986 J01EE07 Berlocombin GDR Sulfamerazine/
trimethoprim
Hepatitis
cholestatic No Kidney infectionFemaleRecovered Certain 18 DF OralHospital36
59 1986 N02BB02 Analgin GDR Metamizole/
lidocain Thrombocytopenia No Calculus of gallbladder FemaleNA Possible NA NAHospital77
1986 N02BB02 Analgin GDR Metamizole/
lidocain
Marrow
depression No Calculus of gallbladder FemaleNA Possible NA NAHospital77
1986 N02BB02 Analgin GDR Metamizole/
lidocain Leucopenia No
Calculus of
gallbladder FemaleNA Possible NA NAHospital77
60 1987 N03AA03 Primidone USSR Primidone Nausea No Epilepsy FemaleRecovered Probable 250 mg OralHospital45
61 1987 M01CB01 Tauredon Byk Gulden Aurothiomalate Rash
erythematous No Rheumatoid arthritis FemaleNot recovered Certain 520 mg IM SP 52
62 1987 G03AA07 Minisiston GDR Ethinylestradiol/
levonorgestrel
Hepatocellular
damage No NA FemaleRecovered Certain 1 DF OralSP 18
63 1987 C02DB01 Depressan GDR Dihydralazine Hepatocellular
damage No Hypertension FemaleNA Probable 50 mg OralGP 48
64 1987 A11GA01 Vitamin C GDR Ascorbic acid Vertigo No Urinary tract
infection Female Recovered Probable NA OralGP 53

L. AAGAARD ET AL. 68
1987 A11GA01 Vitamin C GDR Ascorbic acid Coordination
abnormal No Urinary tract infection Female Recovered Probable NA OralGP 53
65 1987 J01MB02 Negram Yugoslavia Nalidixic acid Rash erythematous No Kidney infectionMaleRecovered Probable 4 DF OralSP 78
66 1986 M01AB05 Rewodina GDR Diclofenac Vertigo No Osteoarthrosis FemaleNot
recovered Possible 150 mg OralGP 77
1986 N04BA01 Dopaflex Hungary Levodopa Oedema legs No Parkinson’s diseaseFemaleNot
recovered Possible 4 DF OralGP 77
1986 N04BA01 Dopaflex Hungary Levodopa Catatonic reaction No Parkinson’s diseaseFemaleNot
recovered Possible 4 DF OralGP 77
67 1986 N04BA01 Dopaflex Hungary Levodopa Haemorrhage nos No Parkinson’s diseaseFemaleRecovered Probable 0.5 mg OralSP 77
1986 N04BA01 Dopaflex Hungary Levodopa Thrombocytopenia No Parkinson’s diseaseFemaleRecovered Probable 0.5 mg OralSP 77
68 1987 G03BA02 Oral-turinabol GDR Testosterone Hepatitis No Nutritional
deficiencies MaleRecovered Probable 15 mg OralHospital70
69 1987 C02DB01 Depressan GDR Dihydralazine Hepatitis No Hypertension FemaleNA Probable 75 mg OralSP 34
70 1987 N06BX01 Cerutil GDR Meclofenoxate Tachycardia No Cerebrovas cular
disease FemaleRecovered Possible 500 mg IV Hospital 56
1987 N06BX01 Cerutil GDR Meclofenoxate Parasthesia No
Cerebrovascular
disease FemaleRecovered Possible 500 mg IV Hospital 56
1987 N06BX01 Cerutil GDR Meclofenoxate Nausea No Cerebrovascular
disease FemaleRecovered Possible 500 mg IV Hospital 56
71 1987 N06BX01 Cerutil GDR Meclofenoxate Tachycardia No Cerebrovas cular
disease FemaleRecovered Possible 500 mg IV Hospital 67
1987 N06BX01 Cerutil GDR Meclofenoxate Parasthesia No
Cerebrovascular
disease FemaleRecovered Possible 500 mg IV Hospital 67
1987 N06BX01 Cerutil GDR Meclofenoxate Nausea No Cerebrovascular
disease FemaleRecovered Possible 500 mg IV Hospital 67
72 1987 P01BA01 Chlorochin GDR Chloroquine Amnesia No Lichen FemaleRecovered Possible 250 mg OralHospital49
1987 P01BA01 Chlorochin GDR Chloroquine Psychosis No Lichen FemaleRecovered Possible 250 mg OralHospital49
73 1987 H03BB02 Thiamazole Merck Thiamazole Hepatitis
cholestatic No Thyrotoxicosis FemaleRecovered Probable 30 mg OralHospital36
74 1987 P03AB02 Hch-Salbe GDR Lindane Convulsions local No Scabies MaleRecovered Probable 80 g Top.Hospital20
1987 P03AB02 Hch-Salbe GDR Lindane Mydriasis No Scabies MaleRecovered Probable 80 g Top.Hospital 20
1987 P03AB02 Hch-Salbe GDR Lindane Tremor No Scabies MaleRecovered Probable 80 g Top.Hospital 20
1987 P03AB02 Hch-Salbe GDR Lindane Sweating
increased No Scabies MaleRecovered Probable 80 g Top.Hospital20
1987 P03AB02 Hch-Salbe GDR Lindane Tachycardia No Scabies MaleRecovered Probable 80 g Top.Hospital20
75 1988 N03AF01 Finlepsin GDR Carbamazepine Hepatocellular
damage No Epilepsy MaleNA Probable 1 DF OralGP 28
1988 N03AF01 Finlepsin GDR Carbamazepine Vomiting No Epilepsy MaleNA Probable 1 DF OralGP 28
1988 N03AF01 Finlepsin GDR Carbamazepine Weight decrease No Epilepsy MaleNA Probable 1 DF OralGP 28
76 1988 M01AA06 Ketazon CSSR Kebuzone Hepatitis
cholestatic No Gout MaleNot recovered Probable 9 DF OralHospital59
77 1988 N03AF01 Finlepsin GDR Carbamazepine Rash
erythematous No Epilepsy FemaleRecovered Probable 150 mg OralHospital5
1988 N03AF01 Finlepsin GDR Carbamazepine Epidermal
necrolysis No Epilepsy FemaleRecovered Probable 150 mg OralHospital5
78 1988 C05BX01 Calcium
dobesilate GDR Calcium dobesilate Angioedema No Phlebitis FemaleRecovered Probable 2 DF OralSP 42
79 1988 J04AC01 INH-Tabletten GDR Isoniazid Petechiae No Tuberculosis MaleNA Probable 3 DF OralGP 44
1988 J04AC01 INH-Tabletten GDR Isoniazid Oedema legs No Tuberculosis MaleNA Probable 3 DF OralGP 44

L. AAGAARD ET AL. 69
1988 J04AC01 INH-Tabletten GDR Isoniazid Circulatory failure No Tuberculosis MaleNA Probable 3 DF OralGP 44
1988 J04AC01 INH-Tabletten GDR Isoniazid Dyspnoea No Tuberculosis MaleNA Probable 3 DF OralGP 44
1988 J04AC01 INH-Tabletten GDR Isoniazid Rash
erythematous No Tuberculosis MaleNA Probable 3 DF OralGP 44
1988 J04AC01 INH-Tabletten GDR Isoniazid Fever No Tuberculosis MaleNA Probable 3 DF OralGP 44
80 1988 M01AB05 Rewodina GDR Diclofenac Bronchospasm No Sciatica MaleNA Certain 2 DF OralHospital44
1988 M01AB05 Rewodina GDR Diclofenac Cyanosis No Sciatica MaleNA Certain 2 DF OralHospital44
1988 M01AB05 Rewodina GDR Diclofenac Dyspnoea No Sciatica MaleNA Certain 2 DF OralHospital44
81 1988 N02BB02 Analgin GDR Metamizole/
lidocain
Anaphylactoid
reaction No NasopharyngitisMaleRecovered Probable 500 mg OralGP 36
82 1988 M01AC01 Piroxicam GDR Piroxicam Gastric ulcer No Spondolysis MaleNot recovered Probable 40 mg Oral Hospital73
83 1988 M01AA06 Ketazon CSSR Kebuzone Hepatitis No Lumbalgia FemaleRecovered Probable 500 mg OralHospital60
84 1988 B02BA01 Kanavit GDR Phytomenadione Anaphylactic
shock No Coagulation factor deficiency FemaleRecovered Certain 20 mg IV Hospital 56
85 1988 N02BB02 Analgin GDR Metamizole/
lidocain
Anaphylactic
shock No Respiratory infection MaleRecovered Probable 750 mg OralGP 57
86 1988 C02AB01 Dopegyt Hungary Methyldopa Hepatitis No Hypertension FemaleRecovered Certain 500 mg OralHospital48
87 1988 C02DB01 Depressan GDR Dihydralazine Hepatitis No Hypertension FemaleRecovered Probable 25 mg OralHospital27
88 1988 C02DB01 Depressan GDR Dihydralazine Hepatitis No Hypertension MaleRecovered Probable 75 mg OralHospital46
89 1988 C02DB01 Depressan GDR Dihydralazine Hepatitis No Hypertension FemaleRecovered Certain 75 mg OralHospital61
90 1988 H02AB06 Prednisolut GDR Prednisolon Dyspnoea No Asthma FemaleRecovered Certain 50 mg IV SP 24
1988 H02AB06 Prednisolut GDR Prednisolon Vomiting No Asthma FemaleRecovered Certain 50 mg IV SP 24
1988 H02AB06 Prednisolut GDR Prednisolon Rash
erythematous No Asthma FemaleRecovered Certain 50 mg IV SP 24
91 1988 M01AC01 Piroxicam GDR Piroxicam Rash
erythematous No Rheumatoid arthritis FemaleNot recovered Probable 40 mg OralGP 46
1988 M01AC01 Piroxicam GDR Piroxicam Pruritus No Rheumatoid
arthritis FemaleNot recovered Probable 40 mg OralGP 46
92 1988 R05DB04 Nullatuss GDR Isoaminile Dizziness No Cough FemaleRecovered Possible 20 gtt OralGP 30
1988 R05DB04 Nullatuss GDR Isoaminile Headache No Cough FemaleRecovered Possible 20 gtt OralGP 30
1988 R05DB04 Nullatuss GDR Isoaminile Sweating
increased No Cough FemaleRecovered Possible 20 gtt OralGP 30
1988 R05DB04 Nullatuss GDR Isoaminile Nausea No Cough FemaleRecovered Possible 20 gtt OralGP 30
93 1988 J01MB02 Negram Yugoslavia Nalidixic acid Vision
abnormal No Kidney infection Female Not recovered Possible 750 mg OralSP 12
94 1988 M01AB05 Rewodina GDR Diclofenac Thrombocytopenia No Rheumatoid
arthritis FemaleRecovered Possible 75 mg OralGP 65
1988 M01AB05 Rewodina GDR Diclofenac Purpura No Rheumatoid
arthritis FemaleRecovered Possible 75 mg OralGP 65
1988 M01AB05 Rewodina GDR Diclofenac Heamaturia No
Rheumatoid
arthritis FemaleRecovered Possible 75 mg OralGP 65
95 1988 J01FA01 Lubomycin-b Poland Erythromycin Hepatitis
cholestatic No Diseases of sebaceous glandsFemale Recovered Probable 800 mg OralHospital18
1988 J01FA01 Lubomycin-b Poland Erythromycin Fever No Diseases of
sebaceous glandsFemale Recovered Probable 800 mg OralHospital18
96 1988 C02DB01 Depressan GDR Dihydralazine Thrombocytopenia No Hypertension MaleRecovered Probable 37 mg Oral Hospital55

L. AAGAARD ET AL. 70
1988 C02DB01 Depressan GDR Dihydralazine Haematuria No Hypertension MaleRecovered Probable 37 mg OralHospital55
1988 C02DB01 Depressan GDR Dihydralazine Purpura No Hypertension MaleRecovered Probable 37 mg Oral Hospital55
1988 C02DB01 Depressan GDR Dihydralazine Melaena No Hypertension MaleRecovered Probable 37 m OralHospital55
97 1988 C07FA05 Obsilazin GDR Propranolol/
dihydralazin Hepatitis No Hypertension FemaleRecovered Certain 0.5 DF OralHospital59
98 1988 J01FA01 Lubomycin-b Poland Erythromycin Hepatitis
cholestatic No Acne of sebaceous glandsFemale Recovered Probable 800 mg OralHospital23
99 1988 J01CE01 Jenacillin-a GDR Benzylpenicillin Rash
erythematous No BronchopneumoniaMaleRecovered Probable 800 kIU IM Hospital2
100 1988 B01AA04 Falithrom GDR Phenprocoumon Hepatitis No Venous
embolism Female Recovered Probable 3 mg OralHospital37
101 1988 A07EC01 Sulfasalazin Yugoslavia Sulfasalazine Pruritus No Ulcerative colitisMaleRecovered Probable 3 g OralHospital72
102 1988 J01EE07 Berlocombin GDR Sulfamerazine/
trimethoprim
Hepatitis
cholestatic No Respiratory infec- tion MaleRecovered Probable 4 DF OralHospital41
103 1988 A02BX05 Pulvis
stomachicus SR GDR Bismuth Neuropathy No Ulcerative colitisMaleNot recovered Certain 36g OralHospital48
1988 A02BX05 Pulvis
stomachicus SR GDR Bismuth Ataxia No Ulcerative colitisMaleNot recovered Certain 36g OralHospital48
104 1988 H03BB02 Methimazole GDR Thiamazole Agranulocytosis No Toxic diffuse goiterFemaleRecovered Certain 30 mg OralHospital28
105 1988 J01EE07 Berlocombin GDR Sulfamerazine/
trimethoprim Flushing No Kidney infectionFemaleRecovered Probable 4 DF OralGP 48
106 1988 N07BB01 Disulfiram GDR Disulfiram Hepatitis No
Alcohol
dependence
syndrome
FemaleRecovered Certain 250 mg OralHospital26
107 1988 C02DB01 Obsilazin GDR Propranolol/
dihydralazin Hepatitis No Hypertension FemaleNot recovered Certain 1.5 DF OralHospital46
108 1988 C08CA05 Corinfar GDR Nifedipine Pruritus No Hypertension FemaleRecovered Certain 60 mg OralGP 57
1988 C08CA05 Corinfar GDR Nifedipine Oedema legs No Hypertension FemaleRecovered Certain 60 mg OralGP 57
109 1998 A10BB01 Maninil GDR Glibenclamide Anaemia
haemolytic No Diabetes mellitusMaleRecovered Possible 3 mg OralHospital64
110 1988 A03FA01 Cerucal GDR Metoclopramide Extrapyramidal
disorder No Gastritis FemaleRecovered Certain 30 mg OralSP 46
111 1988 N02BB04 Propyphenazone GDR Propyphenazone Allergic reaction No NasopharyngitisFemale Recovered Probable 200 mg RectalHospital8
1988 N02BB04 Propyphenazone GDR Propyphenazone Bronchospasm No NasopharyngitisFemaleRecovered Probable 200 mg RectalHospital8
1988 N02BB04 Propyphenazone GDR Propyphenazone Pruritus No NasopharyngitisFemale Recovered Probable 200 mg RectalHospital8
112 1988 J01FA01 Lubomycin-b Poland Erythromycin Hepatocellular
damage No Bronchiti MaleRecovered Certain 1.6 g OralHospital 8
113 1988 N03AG01 Convulsofin GDR Valproic acid Pancreatitis No Epilepsy FemaleRecovered Probable 80 gtt OralHospital8
114 1989 A07EC01 Sulfasalazin Yugoslavia Sulfasalazin Pneumonia No Regional
enteritis FemaleNot recovered Probable 3 g OralHospital34
1989 A07EC01 Sulfasalazin Yugoslavia Sulfasalazin Glossitis No Regional
enteritis FemaleNot recovered Probable 3 g OralHospital34
1989 A07EC01 Sulfasalazin Yugoslavia Sulfasalazin Nausea No Regional
enteritis FemaleNot recovered Probable 3 g OralHospital34
115 1989 J01AA02 Doxycycline GDR Doxycycline Anaphylactic
shock No NA FemaleRecovered Probable 100 mg IV Hospital20
116 1989 M01CC01 Penicillamine CSSR Penicillamine Rash
erythematous No NA FemaleRecovered Certain 3 DF OralHospital55
117 1989 NA Patentblau v BRD Sulphan blue Urticaria No Neoplasm of
prostate MaleRecovered Probable 1 ml SC Hospital 64
118 1989 C02AB01 Dopegyt Hungary Methyldopa Hepatitis No Hypertension FemaleRecovered Probable 250 mg OralHospital53
119 1989 C07FA05 Obsilazin GDR Propranolol/
dihydralazin Hepatitis No Hypertension FemaleRecovered Certain 2 DF OralHospital55

L. AAGAARD ET AL. 71
120 1989 C08CA05 Corinfar GDR Nifedipine Oedema legs No Hypertension FemaleNot
recovered Probable 60 mg OralGP 58
121 1989 C02DB01 Depressan GDR Dihydralazine Hepatitis No Hypertension MaleRecovered Probable 50 mg OralHospital63
122 1989 H02AB06 Prednisolut GDR Prednisolon Respiratory
insufficiency No Asthma FemaleRecovered Possible 50 mg IV Hospital61
123 1989 N02BB02 Analgin GDR Metamizole/
lidocain
Anaphylactic
shock No Respiratory infec- tion Female Recovered Probable 1.5 g OralGP 35
124 1989 N03AF01 Finlepsin GDR Carbamazepine Rash
maculo-papular No
Alcohol
dependence
syndrome
Male Not
recovered Probable 400 mg OralHospital21
1989 N03AF01 Finlepsin GDR Carbamazepine Rash follicular No
Alcohol
dependence
syndrome
Male Not
recovered Probable 400 mg OralHospital21
125 1989 N02BB04 Propyphenazone GDR Propyphenazone Allergic reaction No Respiratory
infection MaleRecovered Probable 200 mg RectalHospital8
1989 N02BB04 Propyphenazone GDR Propyphenazone Bronchospasm No Respiratory
infection MaleRecovered Probable 200 mg RectalHospital8
1989 N02BB04 Propyphenazone GDR Propyphenazone Rash
erythematous No Respiratory infection MaleRecovered Probable 200 mg RectalHospital8
1989 N02BB04 Propyphenazone GDR Propyphenazone Rhinitis No Respiratory
infection MaleRecovered Probable 200 mg RectalHospital8
126 1989 N05AA01 Propaphenin GDR Chlorpromazine Hepatocellular
damage No Constipation FemaleNot recovered Probable 75 mg Oral Hospital42
127 1989 J01CE01 Jenacillin GDR Benzylpenicillin Dyspnoea No Skin disease MaleNA Certain 1 MIU IM GP 60
1989 J01CE01 Jenacillin GDR Benzylpenicillin Parasthesia No Skin disease MaleNA Certain 1 MIU IM GP 60
1989 J01CE01 Jenacillin GDR Benzylpenicillin Cyanosis No Skin disease MaleNA Certain 1 MIU IM GP 60
128 1989 C07FA05 Obsilazin GDR Propranolol/
dihydralazin
Hepatocellular
damage No Hypertension FemaleNot recovered Probable 1 DF OralHospital34
1989 C07FA05 Obsilazin GDR Propranolol/
dihydralazin Jaundice No Hypertension FemaleNot recovered Probable 1 DF OralHospital34
129 1989 D08AC02 Solutio
Chlorhexidini SR GDR Chlorhexidine Anaphylactic shock No Apical peridontitis Male Not recovered Probable 5 ml DentalGP 20
130 1989 R03DA05 Aminophylline GDR Aminophylline Phlebitis No Asthma MaleRecovered Probable 240 mg IV SP 54
131 1989 J01EE07 Berlocombin GDR Sulfamerazine/
trimethoprim Nervousness No
Acute sinusitis
maxillary FemaleRecovered Possible 4 DF OralSP 74
132 1989 J01CE08 Pendysin GDR Benzathine
benzylpenicillin Anxiety No Erysipelas FemaleNA Certain 1 DF IM Hospital75
133 1989 J01AA02 Doxycycline GDR Doxycycline Oesophagitis No Otitis media FemaleRecovered w.
sequaelae Probable 100 mg OralGP 26
134 1988 N02BB02 Analgin GDR Metamizole/
lidocain Agranulocytosis No Streptococcal sore throat FemaleRecovered Possible 3 g OralHospital 14
135 1988 A02BA02 Zantic GlaxoSmith
Kline Ranitidine Hepatitis No
Neoplasm of
digestive systemMaleRecovered Probable 2g OralHospital42
136 1988 A07EC01 Sulfasalazin Yugoslavia Sulfasalazine Urticaria No Ulcerative colitisMaleRecovered Probable 3 g OralHospital72
137 1989 B01AB01 Heparin GDR Heparin Avascular
necrosis of bone No Malignant neo
p
lasm
of rectum FemaleNot recovered Certain 5 kIU SC Hospital76
138 1989 N03AF01 Finlepsin GDR Carbamazepine Rash
maculo-papular No Epilepsy FemaleRecovered Probable 3 DF OralSP 28
1989 N03AF01 Finlepsin GDR Carbamazepine Pruritus No Epilepsy FemaleRecovered Probable 3 DF OralSP 28
139 1989 B01AB01 Heparin GDR Heparin Avascular
necrosis of bone No NA MaleNot recovered Probable 10 kIU SC Hospital40
140 1989 C07FA05 Obsilazin GDR Propranolol/
dihydralazin
Hepatocellular
damage No Hypertension FemaleNot recovered Probable 3.5 DF OralHospital55
141 1989 N03AB02 Phenytoin GDR Phenytoin Dermatitis No Epilepsy MaleRecovered Probable 150 mg OralHospital9
142 1989 C07AB13 Cordanum GDR Talinolol Gastritis No Hypertension FemaleNot
recovered Probable 100 mg OralGP 57
1989 C07AB13 Cordanum GDR Talinolol Blepharitis No Hypertension FemaleNot recovered Probable 100 mg OralGP 57

L. AAGAARD ET AL. 72
1989 C07AB13 Cordanum GDR Talinolol Conjunctivitis No Hypertension FemaleNot recovered Probable 100 mg OralGP 57
1989 C07AB13 Cordanum GDR Talinolol Lacrimation
abnormal No Hypertension FemaleNot recovered Probable 100 mg OralGP 57
1989 C07AB13 Cordanum GDR Talinolol Rash
erythematous No Hypertension FemaleNot recovered Probable 100 mg OralGP 57
1989 C07AB13 Cordanum GDR Talinolol Alopecia No Hypertension FemaleNot recovered Probable 100 mg OralGP 57
143 1989 V08AB05 Ultravist Bayer Iopromide Thrombophlebitis No NA FemaleRecovered w.
sequaelae Certain 50 ml IV Hospital48
1989 V08AB05 Ultravist Bayer Iopromide Embolism
pulmonary No NA FemaleRecovered w. sequaelae Certain 50 ml IV Hospital48
144 1989 J01FA01 Etromycin Orion Erythromycin Hepatocellular
damage No NA MaleRecovered Certain 360 mg Oral Hospital2
1989 J01FA01 Etromycin Orion Erythromycin Sgpt increased No NA MaleRecovered Certain 360 mg OralHospital2
1989 J01FA01 Etromycin Orion Erythromycin Sgot increased No NA MaleRecovered Certain 360 mg OralHospital2
145 1989 N05AH02 Leponex Novartis Clozapine Agranulocytosis No Paranoid type
schizophrenia Female Recovered Probable 200 mg OralHospital24
146 1989 M01AA06 Ketazon CSSR Kebuzone Hepatitis
cholestatic No Back disorder FemaleRecovered Probable 10 ml IM Hospital66
147 1989 M01AC01 Piroxicam GDR Piroxicam Vision abnormal No
Systemic lupus
erythematous MaleRecovered Probable 20 mg OralHospital43
1989 M01AC01 Piroxicam GDR Piroxicam Accommodation
abnormal No Systemic lupus erythematous Malerecovered Probable 20 mg OralHospital43
148 1989 C02DB01 Depressan GDR Dihydralazine Hepatitis No Hypertension MaleRecovered Probable 2 DF OralSP 53
1989 C02DB01 Depressan GDR Dihydralazine Sgot increased No Hypertension Malerecovered Probable 2 DF OralSP 53
1989 C02DB01 Depressan GDR Dihydralazine Sgpt increased No Hypertension Malerecovered Probable 2 DF OralSP 53
149 1989 J01AA02 Doxycycline GDR Doxycycline Vasculitis allergic No NA FemaleRecovered Probable 0.1 g OralHospital40
1989 J01AA02 Doxycycline GDR Doxycycline Fever No NA FemaleRecovered Probable 0.1 g OralHospital 40
150 1989 A08A A Sedafamem GDR Phendimetrazine Psychosis No Obesity MaleRecovered Certain 2 DF OralGP 40
151 1989 N03AG01 Convulsofin GDR Valproic acid Thrombocytopenia No Epilepsy MaleRecovered Certain 3 DF OralHospital12
152 1989 C02DB01 Depressan GDR Dihydralazine Hepatitis
cholestatic No Hypertension MaleRecovered Certain 75 mg OralGP 55
153 1989 M01AA06 Ketazon CSSR Kebuzone Hepatitis No Niple infection FemaleRecovered Probable 250 mg OralHospital25
1989 M01AA06 Ketazon CSSR Kebuzone Hepatitis No Gout FemaleRecovered Probable 750 mg OralHospital49
154 1989 B01AD01 Awelysin GDR Streptokinase Hepatitis No Venous embolismMaleRecovered Probable 3 MIU IV Oral NA
155 1989 B01AB01 Heparin GDR Heparin Avascular
necrosis of bone No NA FemaleNot recovered Probable 10 kIU SC Hospital29
156 1989 N02AC03 Tiretta
analgica “p” GDR
Codeine/
papaverin/
aminophenazone/
phenazone
Anaphylactic
shock No Migraine FemaleRecovered Probable 4 ml IV GP 26
157 1989 B01AD01 Awelysin GDR Streptokinase Anaphylactic
shock No Acute myocardial infection MaleNA Probable 0.2 MIU IV Hospital47
158 1989 S03AA08 Berlicetin GDR Prednisolone/
chloramphenicol Otitis externa No Ear disorder FemaleRecovered Certain 1 ml Top.SP 50
159 1989 S03AA08 Berlicetin GDR Prednisolone/
chloramphenicol Otitis externa No Ear disorder MaleRecovered Certain 1 ml Top.SP 33
1989 S03AA08 Berlicetin GDR Prednisolone/
chloramphenicol Pruritus No Ear disorder MaleRecovered Certain 1 ml Top.SP 33
160 1989 N05AH02 Alemoxan GDR Clozapine Agranulocytosis No Paranoid states FemaleNot
recovered Probable 200 mg OralHospital38
1989 N05AH02 Alemoxan GDR Clozapine Rhinitis No Paranoid states FemaleNot
recovered Probable 200 mg OralHospital38

L. AAGAARD ET AL. 73
1989 N05AH02 Alemoxan GDR Clozapine Bronchitis No Paranoid states FemaleNot
recovered Probable 200 mg OralHospital38
1989 N05AH02 Alemoxan GDR Clozapine Rash pustular No Paranoid states FemaleNot
recovered Probable 200 mg OralHospital38
161 1989 A07EC01 Sulfasalazin Yugoslavia Sulfasalazine Rash
erythematous No Ulcerative colitis MaleRecovered Probable 3.5 g OralHospital52
1989 A07EC01 Sulfasalazin Yugoslavia Sulfasalazine Sgot increased No Ulcerative
colitis MaleRecovered Probable 3.5 g OralHospital52
1989 A07EC01 Sulfasalazin Yugoslavia Sulfasalazine Sgpt increased No Ulcerative
colitis MaleRecovered Probable 3.5 g OralHospital52
1989 A07EC01 Sulfasalazin Yugoslavia Sulfasalazine Leukocytosis No Ulcerative
colitis MaleRecovered Probable 3.5 g OralHospital52
162 1989 M01CB01 Tauredon Byk Gulden Aurothiomalate Purpura No Rheumatoid
arthritis FemaleRecovered Certain 220 mg IM Hospital73
1989 M01CB01 Tauredon Byk Gulden Aurothiomalate Trombocytopenia No Rheumatoid
arthritis FemaleRecovered Certain 220 mg IM Hospital73
163 1989 N03AF01 Finlepsin GDR Carbamazepine Hepatorenal
syndrome No Convulsions MaleNot recovered Possible 1.5 DF OralHospital4
164 1989 A02BA01 Altramet GDR Cimetidine Gynaecomastia No Oesophagitis MaleRecovered Probable 1 g OralHospital62
165 1989 J01GB03 Gentamicin Bulgaria Gentamicin Deafness No Fracture of ribs MaleNot
recovered Probable 120 mg IV Hospital48
166
1990 J01CE01 Penicillin g GDR Benzylpenicillin Anaphylactic shock No NA FemaleRecovered Certain 5 ml IV Hospital24
167 1990 N01AX04 Sombrevin Hungary Propanidid Thrombophlebitis No Phlebitis FemaleRecovered w.
sequaelae Probable NA NAHospital51
168 1990 N01AX04 Sombrevin Hungary Propanidid Thrombophlebitis No Phlebitis Female Recovered Probable NA NAHospital38
169 1990 N01AX04 Sombrevin Hungary Propanidid Thrombophlebitis No Phlebitis Female Recovered Probable NA NAHospital36
170 1990 B01AD01 Awelysin GDR Streptokinase Dizziness No Phlebitis MaleRecovered Certain 1 MIU IV Hospital66
1990 B01AD01 Awelysin GDR Streptokinase Flushing No Phlebitis MaleRecovered Certain 1 MIU IV Hospital66
1990 B01AD01 Awelysin GDR Streptokinase Headache No Phlebitis MaleRecovered Certain 1 MIU IV Hospital66
1990 B01AD01 Awelysin GDR Streptokinase Hypertension No Phlebitis MaleRecovered Certain 1 MIU IV Hospital66
1990 B01AD01 Awelysin GDR Streptokinase Sweating
increased No Phlebitis MaleRecovered Certain 1 MIU IV Hospital66
171 1990 C08CA05 Corinfar GDR Nifedipine Taste
perversion No Hypertension MaleRecovered Probable NA NAGP 49
172 1990 J04AB02 Rifampicin Rumania Rifampicin Nausea No NA FemaleRecovered Possible NA OralSP 41
1990 J04AB02 Rifampicin Rumania Rifampicin Purpura No NA FemaleRecovered Possible NA OralSP 41
1990 J04AB02 Rifampicin Rumania Rifampicin Trombopenia No NA FemaleRecovered Possible NA OralSP 41
173 1990 C02DB01 Depressan GDR Dihydralazine Anxiety No Hypertension FemaleRecovered Probable 25 mg OralGP 34
1990 C02DB01 Depressan GDR Dihydralazine Depression No Hypertension FemaleRecovered Probable 25 mg OralGP 34
1990 C02DB01 Depressan GDR Dihydralazine Hypertension No Hypertension Female Recovered Probable 25 mg OralGP 34
1990 C02DB01 Depressan GDR Dihydralazine Vision abnormal No Hypertension Female Recovered Probable 25 mg OralGP 34
174 1990 B01AB01 Heparin GDR Heparin Nausea No NA MaleRecovered Possible 15 kIU SC Hospital 83
1990 B01AB01 Heparin GDR Heparin Vision abnormal No NA MaleRecovered Possible 15 kIU SC Hospital83
1990 B01AB01 Heparin GDR Heparin Vomiting No NA MaleRecovered Possible 15 kIU SC Hospital 83
175 1990 J04AB02 Rifampicin Rumania Rifampicin Renal failure acute No NA MaleRecovered Possible NA OralSP 57

L. AAGAARD ET AL. 74
176 1990 J01FA01 Lubomycin-b Poland Erythromycin Hepatitis
cholestatic No NA FemaleNA Probable NA OralHospital3
1990 J01FA01 Lubomycin-b Poland Erythromycin Hepatomegaly No NA FemaleNA Probable NA OralHospital3
1990 J01FA01 Lubomycin-b Poland Erythromycin Sgot
increased No NA FemaleNA Probable NA OralHospital3
1990 J01FA01 Lubomycin-b Poland Erythromycin Sgpt
increased No NA FemaleNA Probable NA OralHospital3
177 1990 J01CE01 Jenacillin-a GDR Benzylpenicillin Dizziness No Erysipelas MaleRecovered Probable 2 MIU IM Hospital54
178 1990 N01AB01 Halan GDR Halothane Hepatic function
abnormal No NA MaleRecovered Certain 1 times INHHospital49
1990 N01AB01 Halan GDR Halothane Hepatitis No NA MaleRecovered Certain 1 times INHHospital49
1990 N01AB01 Halan GDR Halothane Eosinophilia No NA MaleRecovered Certain 1 times INHHospital49
1990 N01AB01 Halan GDR Halothane Prothrombin
decreased No NA MaleRecovered Certain 1 times INHHospital49
179 1990 A12AA06 Calcium
dobesilate GDR Calcium dobesilate
Injection site
reaction No Abnormal blood chemistry FemaleNot recovered Certain 20 ml IV Hospital3 mo.
1990 A12AA06 Calcium
dobesilate GDR Calcium dobesilate Calcinosis No
Abnormal blood
chemistry FemaleNot recovered Certain 20 ml IV Hospital3 mo.
180 1990 M03AC01 Pavulon Organon
Teknica Pancuronium Bradycardia YesNA MaleDied Possible mg IC Hospital5 mo.
1990 M03AC01 Pavulon Organon
Teknica Pancuronium Cardiac arrest YesNA MaleDied Possible .4 mg IC Hospital5 mo.
Abbreviations
GP: general practitioner; SP: specialist physician; DF: defined formulation; mo.: months; IV: intravenous; IA: intraar-
teriel; IM: intramuscular; SC: subcutaneous; INH: inhalation; Top: topical; IC: intracardiac; BRD: Bundesrepublic
Deutschland; CSSR: Czechoslovak Socialist Republic.