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
Department of Pharmacology and Pharmacotherapy, Section for Social Pharmacy, Faculty of Pharmaceutical Sciences, University of Copenhagen, Copenhagen, Denmark 2 FKL-Research Centre for Quality in Medicine Use, Copenhagen, Denmark 3 Danish Pharmacovigilance Research project (DANPREP), Copenhagen, Denmark 4 Institut fr Klinische Pharmakologie, Charit University Medicine, Berlin, Germany 5 Institut fr Pharmazie, Ernst Moritz Arndt University, Greifswald, Germany E-mail: laa@farma.ku.dk Received June 11, 2011; revised July 22, 2011; accepted August 2, 2011
1

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) followed 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 lymphatic 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 nonserious, 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 catastrophe in the late 1950s [1], pharmacovigilance systems were established in many western European countries, Canada and Australia [2]. The World Health Organization (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 Mutual Economic Assistance (Comecon) countries, but little is known to the public about the principles of this system. The German Democratic Republic (GDR) was wellCopyright 2011 SciRes.

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 Comecon 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 prescribers and patients, as such type of information was considered as being a state secret and only available to
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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 indometacin (Metindol/Amuno), diclofenac (Rewodina), phenylbutazone (Butazolidin), aminophenazone + phenylbutazone (Wofapyrin) and the antidiarrheal Mexaform plus (phanquinon + dichlorhydroxychinolin) and dichlorhydroxychinolin (Endiaron) existed, but no restrictions for the use of these products were made [4]. For the X-ray contrast agent iomeglamic acid (Falignost) several serious cases of allergies and anaphylactic shocks were reported which led to changes in the production, as radiographic 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.

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 international 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 GDRs Ministry of Health [5]. The system was managed by the Institut fr Arzneimittelwesen der DDR (IfAr), and physicians and pharmacists were required to report ADRs [4-5]. An official reporting form (Meldung von Schdlichen 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 laboratory 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 (prescription medicine, over-the-counter medicine, complementary medicine, herbals, homeopathic medicine, allergen 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 medicines 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: Beratungsbro fr Arzneimittel, which worked for the
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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 identification of the medicine user. ADR reports were provided by the Uppsala Monitoring Centre (UMC) as CIOMS reports, and data from these reports were manually 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
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GDR Ministry of Health. Medicines imported from Western countries had to be paid with Western currencies, 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].

from ages 3 to 10. Less than six percent of ADRs was reported in children up to two years of age and in adolescents (ages 11 - 17). Forty percent of ADRs was reported 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. 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. Approximately 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 general practitioners and 12% of ADRs were reported by specialist physicians. Serious ADRs were only reported by hospital physicians. No ADRs were reported by pharmacists.

3.3. 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 systemic use (19% of ADRs), and medicines for the cardiovascular system (16% of ADRs).

4. Discussion
This is the first study to retrospectively analyse spontaneous 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

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

Table 1. Characteristics of serious adverse drug reactions leading to death reported to Vigibase, German Democratic Republic, 1985-1990.
Case no. Year 1 2 3 4 5 7 8 1985 1988 1988 1988 1988 1989 1989 ATC group M01AB05 P01BD01 N02BB02 J01ED07 J01BA01 J01CA01 M01AA06 N02BB04 M01AA06 P01AB01 V08AA01 M03CA01 N05AH02 Medicine Rewodina Tindurin Analgin Mebacid Berlicetin Ampicillin Ketazone Eufibron Ketazone Clont Visotrast Pavulon Alemoxan Active substance Diclofenac Pyrimethamine Metamizole/lidocain Sulfamerazine Chloramphenicol Ampicillin Kebuzone Propyphenazone Kebuzone Metronidazole Amidotrizoic acid Pancuronium Clozapine Adverse drug reaction (ADR) Pancytopenia Agranulocytosis Agranulocytosis Epidermal necrolysis Marrow depression Anaphylactic shock Purpura Thrombocytopenia Disseminated intravascular coagulation Marrow depression Cardiomyopathy Anaphylactic shock Anaphylactic shock Bradycardia Cardiac arrest Agranulocytosis Indication Spondolysis Perinatal condition Nasopharyngitis Chronic bronchitis Chronic bronchitis Chronic bronchitis Effusion of joint Gender Age (year) Female Male Male Female Female Female Female 64 1 49 61 49 52 74

1988

NA

Male

17

10 11 12 13

1989 1990 1990 1990

NA Hydronephrosis NA NA

Female Male Male Male

51 68 5 mo. 50

NA: not *vailable; mo: months.

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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 submitted 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 causality 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 authorities had been higher, but reports included in this study only represent those reported to VigiBase. In general, the ADR reports were of high quality and thorough, but due to their low number, they only represent a limited 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.

authorities, but information was never communicated to the patients or prescribers.

6. References
[1] [2] E. B. Andrews and R. D. Mann, Pharmacovigilance, 2nd Edition, John Wiley & Sons, Chichester, 2007. W. H. Wardell, G. P. Velo and N. M, Jarocha, Drug Development, Regulatory Assessment and Post Marketing Surveillance, Plenum, New York, 1981. S. Olsson, The Role of the WHO Programme on International Drug Monitoring in Coordination Worldwide Drug Safety Efforts, Drug Safety, Vol. 19, No. 1, 1998, pp. 1-10. doi:10.2165/00002018-199819010-00001 Ministerium fr Gesundheitswesen. Arbeitsgruppe fr Organisation und Inspektion beim Ministerrat, Kontrolabteilung. Bericht ber Stand und erforderliche Massnahmen zur weiteren Erhhung der Arzneimittelsicherheit in der DDR. Pharmazie und Technik. Berlin, 1984. J. Richter and M. Wolski, 40 Jahre Regelung und berwa Chung des Arzneitmittelverkehrs in der Deutschen Demokratischen Republik, Pharmazie, Vol. 44, No. 10, 1989, pp. 666-671. M. Bhm, K. Gerccke, L. Kny, H. Probst and J. Richter, 45 Jahre Pharmazie in Deutschland Ost. 7bDirekt Apothekenservice AG, Frstenfeldbruck, Berlin, 2007. J. Richter, H. J. Seidelin, M. Bhm, H. G. Keune and E. Gueinzius, Arzneimittel-und Apothekenrecht der Republic, Akademie-Verlag, Berlin, 1985. The Medical Dictionary for Regulatory Activities (MedDRA). http://www.meddramsso.com 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

[3]

[4]

[5]

[6]

[7]

[8] [9]

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

[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

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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 Year no. 1 ATC Medicine Prednisolut Prednisolut Prednisolut Distraneurin Distraneurin Distraneurin Distraneurin Calcium dobesilate Haloperidol Haloperidol Haloperidol Haloperidol Phenytoin Dopegyt Dopegyt Finlepsin Nitrofurantin Nitrofurantin Dopegyt Rewodina Rewodina Prednisolut Prednisolut Prednisolut Sulfasalazine Sulfasalazine Altramet Nifurantin Manufacturer GDR GDR GDR AstraZeneca AstraZeneca AstraZeneca AstraZeneca GDR Hungary Hungary Hungary Hungary GDR Hungary Hungary GDR GDR GDR Hungary GDR GDR GDR GDR GDR Yugoslavia Yugoslavia GDR GDR Active substance Prednisolon Prednisolon Prednisolon Clomethiazole Clomethiazole Clomethiazole Clomethiazole Calcium dobesilate Haloperidol Haloperidol Haloperidol Haloperidol Phenytoin Methyldopa Methyldopa Carbamazepine Nitrofurantoin Nitrofurantoin Methyldopa Diclofenac Diclofenac Prednisolon Prednisolon Prednisolon Sulfasalazine Sulfasalazine Cimetidine Nitrofurantoin Adverse drug reaction Bradycardia Apnoea Anaphylactic shock Hypotonia Bradycardia Circulatory failure Anaphylactic shock Fever Palpitation Somnolence Dyskinesia tardive Anxiety Nausea Ataxia Diplopia Rash maculo-papular Alveolitis allergic Fever Fever Anaphylactic shock Bronchospasm Anaphylactic shock Cardiac arrest Apnoea Hepatic necrosis Hepatitis Alopecia Bronchospasm Serious No No No No No No No No No No No No No No No No No No No No No No No No No No No No Indication Bronchitiss Bronchitis Bronchitis Psychoses Psychoses Psychoses Psychoses Retinal disorders Psychoses Psychoses Psychoses Psychoses Epilepsy Hypertension Hypertension Trigeminal nerve disorder Urinary tract infection Urinary tract infection Hypertension Cervical spondylosis Cervical spondylosis Myeloid leukaemia Myeloid leukaemia Myeloid leukaemia Ulcerative colitis Ulcerative colitis Duodenal ulcer Pyelonephritis Gender Male Male Male Male Male Male Male Female Female Female Female Female Female Female Female Female Female Female Male Female Female Female Female Female Male Male Male Male Outcome Recovered Recovered Recovered Recovered Recovered Recovered Recovered NA Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Causality Certain Certain Certain Certain Certain Certain Certain Dose Admin. Reporter 25 mg 25 mg 25 mg 3 DF 3 DF 3 DF 3 DF IV IV IV Hospital Hospital Hospital Age (years) 59 59 59 46 46 46 46 71 10 10 10 10 45 45 45 61 70 70 59 55 55 54 54 54 48 48 30 35

1985 H02AB06 1985 H02AB06 1985 H02AB06

1986 N05CM02 1986 N05CM02

Oral Hospital Oral Hospital Oral Hospital Oral Hospital SP GP GP GP GP GP GP GP SP GP GP

1986 N05CM02 1986 N05CM02

3 4

1986 C05BX01 1986 N05AD01 1986 N05AD01 1986 N05AD01 1986 N05AD01

Probable 750 mg Oral Certain Certain Certain Certain 3 mg 3 mg 3 mg 3 mg Oral Oral Oral Oral

1986 N03AB02 1986 C02AB01 1986 C02AB01

Possible 300 mg Oral Possible 300 mg Oral Possible 300 mg Oral Certain Certain Certain Certain Possible Possible 400 mg Oral NA NA Oral Oral

6 7

1986 N03AF01 1987 1987 J01XE01 J01XE01

8 9

1987 C02AB01 1988 M01AB05 1988 M01AB05

500 mg Oral Hospital 2 DF 2 DF 100 mg 100 mg 100 mg 8 DF 8 DF Oral Hospital Oral Hospital IV IV IV SP SP SP

10

1989 H02AB06 1989 H02AB06 1989 H02AB06

Recovered w. Certain sequaelae Recovered w. Certain sequaelae Recovered w. Certain sequaelae Recovered w. Certain sequaelae Recovered w. Certain sequaelae Recovered Recovered

11

1989 A07EC01 1989 A07EC01

Oral Hospital Oral Hospital

12 13

1989 A02BA01 1989 J01XE01

Probable 800 mg Oral Hospital Certain 200 mg Oral Hospital

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L. AAGAARD
1989 1989 1989 14 J01XE01 J01XE01 J01XE01 Nifurantin Nifurantin Nifurantin Avlosulfon Avlosulfon Avlosulfon Avlosulfon Avlosulfon Cerutil Cerutil Rewodina Rewodina Tindurin Tindurin Analgin Analgin Mebacid Mebacid Berlicetin Berlicetin Ampicillin Ampicillin Ketazon Ketazon Ketazon Ketazon Eufibron Eufibron Eufibron Clont Clont Visotrast GDR GDR GDR Wyeth-Ayerst Wyeth-Ayerst Wyeth-Ayerst Wyeth-Ayerst Wyeth-Ayerst GDR GDR GDR GDR Hungary Hungary GDR GDR GDR GDR GDR GDR Bulgaria Bulgaria CSSR CSSR CSSR CSSR GDR GDR GDR Bayer Bayer GDR Nitrofurantoin Nitrofurantoin Nitrofurantoin Dapsone Dapsone Dapsone Dapsone Dapsone Meclofenoxate Meclofenoxate Diclofenac Diclofenac Pyrimethamine Pyrimethamine Metamizole/ lidocain Metamizole/ lidocain Sulfamerazine Sulfamerazine Chloramphenicol Chloramphenicol Ampicillin Ampicillin Kebuzone Kebuzone Kebuzone Kebuzone Propyphenazone Propyphenazone Propyphenazone Metronidazole Metronidazole Amidotrizoic acid Cyanosis Coughing Fever Anaemia haemolytic Conjunctivitis Methaemoglobinaemia Sgpt increased Sgot increased Arrhytmia Headache Pancytopenia Death Agranulocytosis Death Agranulocytosis Death Epidermal necrolysis Death Marrow depression Death Anaphylactic shock Death Purpura Thrombocytopenia Death Death Dic Marrow depression Cardiomyopathy Anaphylactic shock Death Anaphylactic shock

ET AL.
No No No No No No No No No No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Pyelonephritis Pyelonephritis Pyelonephritis Erythematous conditions Erythematous conditions Erythematous conditions Erythematous conditions Erythematous conditions Stress Stress Spondolysis Spondolysis Perinatal condition Perinatal condition Nasopharyngitis Nasopharyngitis Bronchitis Bronchitis Bronchitis Bronchitis Bronchitis Bronchitis Effusion of joint Effusion of joint Effusion of joint NA NA NA NA NA NA Hydronephrosis Male Male Male Female Female Female Female Female Male Male Female Female Male Male Male Male Female Female Female Female Female Female Female Female Female Male Male Male Male Female Female Male Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Died Died Died Died Died Died Died Died Died Died Died Died Died Died Died Died Died Died Died Died Died Died Certain Certain Certain Certain Certain Certain Certain Certain Certain Certain Possible Possible Certain Certain Possible Possible Probable Probable Probable Probable Probable Probable Certain Certain Certain Probable Probable Probable Probable 200 mg Oral Hospital 200 mg Oral Hospital 200 mg Oral Hospital 2.5 DF 2.5 DF 2.5 DF 2.5 DF 2.5 DF Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital GP GP

65
35 35 35 33 33 33 33 33 54 54 64 64 1 1 49 49 61 61 49 49 52 52 74 74 74 17 17 17 17 51 51 68

1989 D10AX05 1989 D10AX05 1989 D10AX05 1989 D10AX05 1989 D10AX05

15

1989 N06BX01 1989 N06BX01

300 mg Oral 300 mg Oral 50 mg 50 mg

16

1985 M01AB05 1985 M01AB05

Oral Hospital Oral Hospital

17

1988 P01BD01 1988 P01BD01

450 mg Oral Hospital 450 mg Oral Hospital 14 g 14 g 1g 1g 2g 2g 4g 4g 0.5 g 0.5 g 0.5 g NA NA NA NA Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital IV IV Hospital Hospital

18

1988 N02BB02 1988 N02BB02

19

1988 1988

J01ED07 J01ED07 J01BA01 J01BA01 J01CA01

20

1988 1988

21

1989

1989 J01CA01 22 1989 M01AA06 1989 M01AA06 1989 M01AA06 23 1988 M01AA06 1988 N02BB04 1988 N02BB04 1988 N02BB04 24 1989 P01AB01 1989 P01AB01 25 1990 V08AA01

Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital IV IV IV Hospital Hospital Hospital

Probable 500 mg Probable 500 mg Certain 35 ml

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1990 V08AA01 26 27 1990 N05AH02 1985 N05AH02 1985 N05AH02 1985 N05AH02 28 1985 C02DB01 1985 C02DB01 29 30 31 1986 M01AE01 1986 M01AA06 1986 J01X E01 1986 J01X E01 1986 J01X E01 1986 J01X E01 1986 J01X E01 32 1986 B05CB10 1986 B05CB10 1986 B05CB10 33 1986 B05CB10 1986 B05CB10 34 35 36 37 1986 A03FA01 1986 N05BA01 1986 1986 1986 J01XE01 J01EE07 J01EE07 Visotrast Alemoxan Clozapine Clozapine Clozapine Obsilazin Obsilazin Ibuprofen Ketazon Nitrofurantin Nitrofurantin Nitrofurantin Nitrofurantin Nitrofurantin Infukoll m40 Infukoll m40 Infukoll m40 Infukoll m40 Infukoll m40 Cerucal Faustan Nitrofurantin Berlocombin Berlocombin Trachiform Trachiform Berlocombin Berlocombin Infukoll m40 Infukoll m40 Infukoll m40 Depressan GDR GDR Novartis Novartis Novartis GDR GDR Poland CSSR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR Amidotrizoic acid Clozapine Clozapine Clozapine Clozapine Propranolol/ dihydralazin Propranolol/ dihydralazin Ibuprofen Kebuzone Nitrofurantoin Nitrofurantoin Nitrofurantoin Nitrofurantoin Nitrofurantoin Sodium chloride/ dextran 40 Sodium chloride/ dextran 40 Sodium schloride/ dextran 40 Sodium chloride/ dextran 40 Sodium chloride/ dextran 40 Metoclopramide Diazepam Nitrofurantoin Sulfamerazine /trimethoprim Sulfamerazine/ trimethoprim Benzocaine/ cetylpyridinium Benzocaine/ cetylpyridinium Sulfamerazine/ trimethoprim Sulfamerazine/ trimethoprim Sodium chloride/ dextran 40 Sodium chloride/ dextran 40 Sodium chloride/ dextran 40 Dihydralazine

L. AAGAARD
Death Agranulocytosis Agranulocytosis Fever Rash erythematous Hepatitis necrosis Hepatitis Haematuria Hepatitis Spasm generalized Tachycardia Hypotension Pruritus Vomiting Hypotonia Tachycardia Anaphylactic shock Hypotonia Dyspnoea Depression Rash erythematous Urticaria acute Pruritus Rash erythematous Pruritus Rash erythematous Rash erythematous Erythema exudativum Bronchospasm Circulatory failure Anaphylactic shock Hepatocellular damage

ET AL.
Yes Yes No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No Hydronephrosis NA Schizophrenia Schizophrenia Schizophrenia Hypertension Hypertension Pain Ankylosing spondylitis Cystitis Cystitis Cystitis Cystitis Cystitis Cerebral ischaemia Cerebral ischaemia Cerebral ischaemia Atherosclerosis Atherosclerosis Acute gastritis Cardiovascular malfunction Urinary tract infection Respiratory infection Respiratory infection Respiratory infection Respiratory infection Respiratory infection Respiratory infection Cerebral ischaemia Cerebral ischaemia Cerebral ischaemia Hypertension Male Male Male Male Male Female Female Female Female Female Female Female Female Female Male Male Male Female Female Female Female Female Female Female Female Female Female Male Female Female Female Female Died Died Recovered Recovered Recovered NA NA Recovered NA NA NA NA NA NA Recovered Recovered Recovered Recovered Recovered NA Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Certain 35 ml IV Hospital 68 50 49 49 49 52 52 35 46 34 34 34 34 34 84 84 84 70 70 60 35 35 42 42 42 42 76 57 70 70 70 48

Probable 200 mg Oral Hospital Certain Certain Certain Certain Certain 250 mg Oral Hospital 250 mg Oral Hospital 250 mg Oral Hospital 1.5 DF 1.5 DF Oral Hospital Oral Hospital GP

Probable 600 mg Oral Probable Certain Certain Certain Certain Certain Certain Certain Certain 1.5 g

Oral Hospital GP GP GP GP GP Hospital Hospital Hospital Hospital Hospital GP GP GP GP GP GP GP GP

100 mg Oral 100 mg Oral 100 mg Oral 100 mg Oral 100 mg Oral 10 ml 10 ml 10 ml IV IV IV IV IV Oral Oral

Probable 250 ml Probable 250 ml Possible Possible Certain Probable Probable Probable Probable Probable Certain Certain Certain Certain Certain 30 mg 15mg

100 mg Oral 4 DF 4 DF 6 DF 6 DF 4 DF 6DF 10 ml 10 ml 10 ml 75 mg Oral Oral Oral Oral Oral

1986 B05CA01 1986 B05CA01 38 39 40 1986 1986 J01EE07 J01EE07

Oral Hospital IV IV IV Hospital Hospital Hospital

1986 B05CB10 1986 B05CB10 1986 B05CB10

41

1986 C02DB01

Oral Hospital

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L. AAGAARD
42 43 44 45 1986 C08CA05 1986 C02AB01 1986 V03AB14 1986 C02DB01 1986 C02DB01 1986 C02DB01 1986 C02DB01 1986 C02DB01 46 47 1986 J04AB02 Corinfar Dopegyt Protamin Obsilazin Obsilazin Obsilazin Obsilazin Obsilazin Rifampicin Cerucal Cerucal Cerucal Rewodina Analgin Koreberon Nitrofurantin Ferrum-IIISaccharose Ketazon Doxymycin INH_Tabletten INH-Tabletten Pyrilax Pyrilax Berlocombin Analgin Analgin Analgin Primidone Tauredon Minisiston Depressan Vitamin C GDR Hungary GDR GDR GDR GDR GDR GDR Romania GDR GDR GDR GDR GDR GDR GDR Bulgaria CSSR GDR GDR GDR GDR GDR GDR GDR GDR GDR USSR Byk Gulden GDR GDR GDR Nifedipine Methyldopa Protamin Propranolol/ dihydralazin Propranolol/ dihydralazin Propranolol/ dihydralazin Propranolol/ dihydralazin Propranolol/ dihydralazin Rifampicin Metoclopramide Metoclopramide Metoclopramide Diclofenac Metamizole/ Lidocain Sodium fluoride Nitrofurantoin Ferrum-IIISaccharose Kebuzone Doxycycline Isoniazid Isoniazid Bisacodyl Bisacodyl Sulfamerazine/ trimethoprim Metamizole/ lidocain Metamizole/ lidocain Metamizole/ lidocain Primidone Aurothiomalate Ethinylestradiol/ levonorgestrel Dihydralazine Ascorbic acid Oedema legs Anaemia haemolytic Anaphylactic shock Hepatocellular damage Jaundice Sgot increased Sgpt increased Bilirubinaemia Thrombocytopenia Dystonia Oculogyric crisis Torticollis Anaphylactoid reaction Agranulocytosis Parasthesia Anaphylactic shock Anaphylactic shock Hepatitis cholestatic Hepatocellular damage Muscle atrophy Neuropathy Anaphylactoid reaction Anaphylactoid reaction Hepatitis cholestatic Thrombocytopenia Marrow depression Leucopenia Nausea Rash erythematous Hepatocellular damage Hepatocellular damage Vertigo

ET AL.
No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No Hypertension Hypertension Neoplasms Hypertension Hypertension Hypertension Hypertension Hypertension Tuberculosis Gastritis Gastritis Gastritis Spondylosis Respiratory infection Osteoporosis Urinary tract infection Iron deficiency anaemia Crystal arthropahy Diseases of endocardium Pulmonary uberculosis Pulmonary uberculosis Constipation Constipation Kidney infection Calculus of gallbladder Calculus of gallbladder Calculus of gallbladder Epilepsy Rheumatoid arthritis NA Hypertension Urinary tract infection Male Male Female Female Female Female Female Female Male Female Female Female Female Male Male Female Female Female Male Male Male Female Female Female Female Female Female Female Female Female Female Female Recovered NA Recovered Recovered Recovered Recovered Recovered Recovered Not recovered Recovered Recovered Recovered Recovered Recovered Not recovered Recovered Recovered Recovered Recovered Probable 30 mg Probable Certain Certain Certain Certain Certain Certain 2g 45 mg 1 DF 1 DF 1 DF 1 DF 1 DF Oral GP

67
49 55 33 78 78 78 78 78 65 18 18 18 54 76 49 54 29 21 50 45 45 75 61 36 77 77 77 45 52 18 48 53

Oral Hospital IA NA

Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital SP

Possible 600 mg Oral Probable 50 mg Probable 50 mg Probable 50 mg Probable 25 mg Probable 1.5 DF Possible 60 mg

1986 A03FA01 1986 A03FA01 1986 A03FA01

Oral Hospital Oral Hospital Oral Hospital Oral GP

48 49 50 51 52

1986 M01AB05 1986 N02BB02 1986 A01AA01 1986 J01XE01

Oral Hospital Oral GP

Probable 100 mg Oral Hospital Certain Certain Probable 400 mg IV SP SP

1986 B03AB02 1986 M01AA06 1986 J01AA02 1986 J04AC01 1986 J04AC01

53 54 55

250 mg Oral 1 DF NA NA

Oral Hospital Oral Oral SP SP

Recovered w. Probable sequaelae Recovered w. Probable sequaelae Recovered Recovered Recovered NA NA NA Recovered Not recovered Recovered NA Recovered

56 57 58 59

1986 A06AB02 1986 A06AB02 1986 J01EE07

Probable 10 mg Rectal Hospital Probable 10 mg Rectal Hospital Certain Possible Possible Possible 18 DF NA NA NA Oral Hospital NA NA NA Hospital Hospital Hospital

1986 N02BB02 1986 N02BB02 1986 N02BB02

60 61 62 63 64

1987 N03AA03 1987 M01CB01 1987 G03AA07 1987 C02DB01 1987 A11GA01

Probable 250 mg Oral Hospital Certain Certain 520 mg 1 DF IM Oral Oral Oral SP SP GP GP

Probable 50 mg Probable NA

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1987 A11GA01 65 66 1987 J01MB02 1986 M01AB05 1986 N04BA01 1986 N04BA01 67 1986 N04BA01 1986 N04BA01 68 69 70 1987 G03BA02 1987 C02DB01 1987 N06BX01 1987 N06BX01 1987 N06BX01 71 1987 N06BX01 1987 N06BX01 1987 N06BX01 72 1987 P01BA01 1987 P01BA01 73 74 1987 H03BB02 1987 P03AB02 1987 P03AB02 1987 P03AB02 1987 P03AB02 1987 P03AB02 75 1988 N03AF01 1988 N03AF01 1988 N03AF01 76 77 1988 M01AA06 1988 N03AF01 1988 N03AF01 78 79 1988 C05BX01 1988 J04AC01 1988 J04AC01 Vitamin C Negram Rewodina Dopaflex Dopaflex Dopaflex Dopaflex Oral-turinabol Depressan Cerutil Cerutil Cerutil Cerutil Cerutil Cerutil Chlorochin Chlorochin Thiamazole Hch-Salbe Hch-Salbe Hch-Salbe Hch-Salbe Hch-Salbe Finlepsin Finlepsin Finlepsin Ketazon Finlepsin Finlepsin Calcium dobesilate INH-Tabletten INH-Tabletten GDR Yugoslavia GDR Hungary Hungary Hungary Hungary GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR Merck GDR GDR GDR GDR GDR GDR GDR GDR CSSR GDR GDR GDR GDR GDR Ascorbic acid Nalidixic acid Diclofenac Levodopa Levodopa Levodopa Levodopa Testosterone Dihydralazine Meclofenoxate Meclofenoxate Meclofenoxate Meclofenoxate Meclofenoxate Meclofenoxate Chloroquine Chloroquine Thiamazole Lindane Lindane Lindane Lindane Lindane Carbamazepine Carbamazepine Carbamazepine Kebuzone Carbamazepine Carbamazepine Calcium dobesilate Isoniazid Isoniazid

L. AAGAARD
Coordination abnormal Rash erythematous Vertigo Oedema legs Catatonic reaction Haemorrhage nos Thrombocytopenia Hepatitis Hepatitis Tachycardia Parasthesia Nausea Tachycardia Parasthesia Nausea Amnesia Psychosis Hepatitis cholestatic Convulsions local Mydriasis Tremor Sweating increased Tachycardia Hepatocellular damage Vomiting Weight decrease Hepatitis cholestatic Rash erythematous Epidermal necrolysis Angioedema Petechiae Oedema legs

ET AL.
No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No Urinary tract infection Kidney infection Osteoarthrosis Female Male Female Recovered Recovered Not recovered Not recovered Not recovered Recovered Recovered Recovered NA Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered NA NA NA Probable Probable NA 4 DF Oral Oral GP SP GP GP GP SP SP 53 78 77 77 77 77 77 70 34 56 56 56 67 67 67 49 49 36 20 20 20 20 20 28 28 28 59 5 5 42 44 44

Possible 150 mg Oral Possible Possible 4 DF 4 DF Oral Oral Oral Oral

Parkinsons disease Female Parkinsons disease Female Parkinsons disease Female Parkinsons disease Female Nutritional deficiencies Hypertension Cerebrovascular disease Cerebrovascular disease Cerebrovascular disease Cerebrovascular disease Cerebrovascular disease Cerebrovascular disease Lichen Lichen Thyrotoxicosis Scabies Scabies Scabies Scabies Scabies Epilepsy Epilepsy Epilepsy Gout Epilepsy Epilepsy Phlebitis Tuberculosis Tuberculosis Male Female Female Female Female Female Female Female Female Female Female Male Male Male Male Male Male Male Male

Probable 0.5 mg Probable 0.5 mg Probable 15 mg Probable 75 mg Possible 500 mg Possible 500 mg Possible 500 mg Possible 500 mg Possible 500 mg Possible 500 mg

Oral Hospital Oral IV IV IV IV IV IV SP Hospital Hospital Hospital Hospital Hospital Hospital

Possible 250 mg Oral Hospital Possible 250 mg Oral Hospital Probable 30 mg Probable Probable Probable Probable Probable Probable Probable Probable 80 g 80 g 80 g 80 g 80 g 1 DF 1 DF 1 DF 9 DF Oral Hospital Top. Hospital Top. Hospital Top. Hospital Top. Hospital Top. Hospital Oral Oral Oral GP GP GP

Male Not recovered Probable Female Female Female Male Male Recovered Recovered Recovered NA NA

Oral Hospital

Probable 150 mg Oral Hospital Probable 150 mg Oral Hospital Probable Probable Probable 2 DF 3 DF 3 DF Oral Oral Oral SP GP GP

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L. AAGAARD
1988 J04AC01 1988 J04AC01 1988 J04AC01 1988 J04AC01 80 1988 M01AB05 1988 M01AB05 1988 M01AB05 81 82 83 84 85 86 87 88 89 90 1988 N02BB02 1988 M01AC01 1988 M01AA06 1988 B02BA01 1988 N02BB02 1988 C02AB01 1988 C02DB01 1988 C02DB01 1988 C02DB01 1988 H02AB06 1988 H02AB06 1988 H02AB06 91 1988 M01AC01 1988 M01AC01 92 1988 R05DB04 1988 R05DB04 1988 R05DB04 1988 R05DB04 93 94 1988 J01MB02 1988 M01AB05 1988 M01AB05 1988 M01AB05 95 1988 1988 96 J01FA01 J01FA01 INH-Tabletten INH-Tabletten INH-Tabletten INH-Tabletten Rewodina Rewodina Rewodina Analgin Piroxicam Ketazon Kanavit Analgin Dopegyt Depressan Depressan Depressan Prednisolut Prednisolut Prednisolut Piroxicam Piroxicam Nullatuss Nullatuss Nullatuss Nullatuss Negram Rewodina Rewodina Rewodina Lubomycin-b Lubomycin-b Depressan GDR GDR GDR GDR GDR GDR GDR GDR GDR CSSR GDR GDR Hungary GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR Yugoslavia GDR GDR GDR Poland Poland GDR Isoniazid Isoniazid Isoniazid Isoniazid Diclofenac Diclofenac Diclofenac Metamizole/ lidocain Piroxicam Kebuzone Phytomenadione Metamizole/ lidocain Methyldopa Dihydralazine Dihydralazine Dihydralazine Prednisolon Prednisolon Prednisolon Piroxicam Piroxicam Isoaminile Isoaminile Isoaminile Isoaminile Nalidixic acid Diclofenac Diclofenac Diclofenac Erythromycin Erythromycin Dihydralazine Circulatory failure Dyspnoea Rash erythematous Fever Bronchospasm Cyanosis Dyspnoea Anaphylactoid reaction Gastric ulcer Hepatitis Anaphylactic shock Anaphylactic shock Hepatitis Hepatitis Hepatitis Hepatitis Dyspnoea Vomiting Rash erythematous Rash erythematous Pruritus Dizziness Headache Sweating increased Nausea Vision abnormal Thrombocytopenia Purpura Heamaturia Hepatitis cholestatic Fever Thrombocytopenia

ET AL.
No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No Tuberculosis Tuberculosis Tuberculosis Tuberculosis Sciatica Sciatica Sciatica Nasopharyngitis Spondolysis Lumbalgia Male Male Male Male Male Male Male Male NA NA NA NA NA NA NA Recovered Probable Probable Probable Probable Certain Certain Certain 3 DF 3 DF 3 DF 3 DF 2 DF 2 DF 2 DF Oral Oral Oral Oral GP GP GP GP

69
44 44 44 44 44 44 44 36 73 60 56 57 48 27 46 61 24 24 24 46 46 30 30 30 30 12 65 65 65 18 18 55

Oral Hospital Oral Hospital Oral Hospital GP

Probable 500 mg Oral

Male Not recovered Probable 40 mg Female Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Not recovered Not recovered Recovered Recovered Recovered Recovered Not recovered Recovered Recovered Recovered Recovered Recovered Recovered

Oral Hospital

Probable 500 mg Oral Hospital Certain 20 mg IV Hospital GP

Coagulation factor Female deficiency Respiratory infection Hypertension Hypertension Hypertension Hypertension Asthma Asthma Asthma Rheumatoid arthritis Rheumatoid arthritis Cough Cough Cough Cough Kidney infection Rheumatoid arthritis Rheumatoid arthritis Rheumatoid arthritis Diseases of sebaceous glands Diseases of sebaceous glands Hypertension Male Female Female Male Female Female Female Female Female Female Female Female Female Female Female Female Female Female Female Female Male

Probable 750 mg Oral Certain

500 mg Oral Hospital Oral Hospital Oral Hospital Oral Hospital IV IV IV Oral Oral Oral Oral Oral Oral SP SP SP GP GP GP GP GP GP SP GP GP GP

Probable 25 mg Probable 75 mg Certain Certain Certain Certain 75 mg 50 mg 50 mg 50 mg

Probable 40 mg Probable 40 mg Possible Possible Possible Possible 20 gtt 20 gtt 20 gtt 20 gtt

Possible 750 mg Oral Possible Possible Possible 75 mg 75 mg 75 mg Oral Oral Oral

Probable 800 mg Oral Hospital Probable 800 mg Oral Hospital Probable 37 mg Oral Hospital

1988 C02DB01

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70
1988 C02DB01 1988 C02DB01 1988 C02DB01 97 98 99 1988 C07FA05 1988 1988 J01FA01 J01CE01 Depressan Depressan Depressan Obsilazin Lubomycin-b Jenacillin-a Falithrom Sulfasalazin Berlocombin Pulvis stomachicus SR Pulvis stomachicus SR Methimazole Berlocombin GDR GDR GDR GDR Poland GDR GDR Yugoslavia GDR GDR GDR GDR GDR Dihydralazine Dihydralazine Dihydralazine Propranolol/ dihydralazin Erythromycin Benzylpenicillin Phenprocoumon Sulfasalazine Sulfamerazine/ trimethoprim Bismuth Bismuth Thiamazole Sulfamerazine/ trimethoprim Disulfiram Propranolol/ dihydralazin Nifedipine Nifedipine Glibenclamide Metoclopramide Propyphenazone Propyphenazone Propyphenazone Erythromycin Valproic acid Sulfasalazin Sulfasalazin Sulfasalazin Doxycycline Penicillamine Sulphan blue Methyldopa Propranolol/ dihydralazin

L. AAGAARD
Haematuria Purpura Melaena Hepatitis Hepatitis cholestatic Rash erythematous Hepatitis Pruritus Hepatitis cholestatic Neuropathy Ataxia Agranulocytosis Flushing

ET AL.
No No No No No No No No No No No No No Hypertension Hypertension Hypertension Hypertension Acne of sebaceous glands Bronchopneumonia Venous embolism Ulcerative colitis Respiratory infection Ulcerative colitis Ulcerative colitis Male Male Male Female Female Male Female Male Male Male Male Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Not recovered Not recovered Recovered Recovered Probable 37 mg Probable 37 mg Probable Certain 37 m 0.5 DF Oral Hospital Oral Hospital Oral Hospital Oral Hospital 55 55 55 59 23 2 37 72 41 48 48 28 48

Probable 800 mg Oral Hospital Probable 800 kIU Probable Probable Probable Certain Certain Certain Probable 3 mg 3g 4 DF 36g 36g 30 mg 4 DF IM Hospital

100 1988 B01AA04 101 1988 A07EC01 102 1988 J01EE07

Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral GP

103 1988 A02BX05 1988 A02BX05 104 1988 H03BB02 105 1988 J01EE07

Toxic diffuse goiter Female Kidney infection Alcohol dependence syndrome Hypertension Hypertension Hypertension Diabetes mellitus Gastritis Nasopharyngitis Nasopharyngitis Nasopharyngitis Bronchiti Epilepsy Regional enteritis Regional enteritis Regional enteritis NA NA Neoplasm of prostate Hypertension Hypertension Female

106 1988 N07BB01

Disulfiram

GDR

Hepatitis

No

Female

Recovered

Certain

250 mg Oral Hospital

26

107 1988 C02DB01 108 1988 C08CA05 1988 C08CA05 109 1998 A10BB01 110 1988 A03FA01

Obsilazin Corinfar Corinfar Maninil Cerucal

GDR GDR GDR GDR GDR GDR GDR GDR Poland GDR Yugoslavia Yugoslavia Yugoslavia GDR CSSR BRD Hungary GDR

Hepatitis Pruritus Oedema legs Anaemia haemolytic Extrapyramidal disorder Allergic reaction Bronchospasm Pruritus Hepatocellular damage Pancreatitis Pneumonia Glossitis Nausea Anaphylactic shock Rash erythematous Urticaria Hepatitis Hepatitis

No No No No No No No No No No No No No No No No No No

Female Not recovered Certain Female Female Male Female Female Female Female Male Female Female Female Female Female Female Male Female Female Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Not recovered Not recovered Not recovered Recovered Recovered Recovered Recovered Recovered Certain Certain Possible Certain

1.5 DF 60 mg 60 mg 3 mg 30 mg

Oral Hospital Oral Oral GP GP

46 57 57 64 46 8 8 8 8 8 34 34 34 20 55 64 53 55

Oral Hospital Oral SP

111 1988 N02BB04 Propyphenazone 1988 N02BB04 Propyphenazone 1988 N02BB04 Propyphenazone 112 1988 J01FA01 Lubomycin-b Convulsofin Sulfasalazin Sulfasalazin Sulfasalazin Doxycycline Penicillamine Patentblau v Dopegyt Obsilazin

Probable 200 mg Rectal Hospital Probable 200 mg Rectal Hospital Probable 200 mg Rectal Hospital Certain Probable Probable Probable Probable 1.6 g 80 gtt 3g 3g 3g Oral Hospital Oral Hospital Oral Hospital Oral Hospital Oral Hospital IV Hospital

113 1988 N03AG01 114 1989 A07EC01 1989 A07EC01 1989 A07EC01 115 1989 J01AA02 116 1989 M01CC01 117 1989 NA

Probable 100 mg Certain Probable 3 DF 1 ml

Oral Hospital SC Hospital

118 1989 C02AB01 119 1989 C07FA05

Probable 250 mg Oral Hospital Certain 2 DF Oral Hospital

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L. AAGAARD
120 1989 C08CA05 121 1989 C02DB01 122 1989 H02AB06 123 1989 N02BB02 Corinfar Depressan Prednisolut Analgin GDR GDR GDR GDR Nifedipine Dihydralazine Prednisolon Metamizole/ lidocain Carbamazepine Oedema legs Hepatitis Respiratory insufficiency Anaphylactic shock Rash maculo-papular

ET AL.
No No No No Hypertension Hypertension Asthma Respiratory infection Alcohol dependence syndrome Alcohol dependence syndrome Respiratory infection Respiratory infection Respiratory infection Respiratory infection Constipation Skin disease Skin disease Skin disease Hypertension Hypertension Apical peridontitis Asthma Acute sinusitis maxillary Erysipelas Otitis media Streptococcal sore throat Neoplasm of digestive system Ulcerative colitis Female Male Female Female Not recovered Recovered Recovered Recovered Not recovered Not recovered Recovered Recovered Recovered Recovered Not recovered NA NA NA Not recovered Probable 60 mg Probable 50 mg Possible Probable 50 mg 1.5 g Oral GP

71
58 63 61 35

Oral Hospital IV Oral Hospital GP

124 1989 N03AF01

Finlepsin

GDR

No

Male

Probable 400 mg Oral Hospital

21

1989 N03AF01

Finlepsin

GDR

Carbamazepine

Rash follicular

No

Male

Probable 400 mg Oral Hospital

21

125 1989 N02BB04 Propyphenazone 1989 N02BB04 Propyphenazone 1989 N02BB04 Propyphenazone 1989 N02BB04 Propyphenazone 126 1989 N05AA01 127 1989 1989 1989 J01CE01 J01CE01 J01CE01 Propaphenin Jenacillin Jenacillin Jenacillin Obsilazin Obsilazin Solutio Chlorhexidini SR Aminophylline Berlocombin Pendysin Doxycycline Analgin Zantic Sulfasalazin Heparin Finlepsin Finlepsin Heparin Obsilazin Phenytoin Cordanum Cordanum

GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR GlaxoSmith Kline Yugoslavia GDR GDR GDR GDR GDR GDR GDR GDR

Propyphenazone Propyphenazone Propyphenazone Propyphenazone Chlorpromazine Benzylpenicillin Benzylpenicillin Benzylpenicillin Propranolol/ dihydralazin Propranolol/ dihydralazin Chlorhexidine Aminophylline Sulfamerazine/ trimethoprim Benzathine benzylpenicillin Doxycycline Metamizole/ lidocain Ranitidine Sulfasalazine Heparin Carbamazepine Carbamazepine Heparin Propranolol/ dihydralazin Phenytoin Talinolol Talinolol

Allergic reaction Bronchospasm Rash erythematous Rhinitis Hepatocellular damage Dyspnoea Parasthesia Cyanosis Hepatocellular damage Jaundice Anaphylactic shock Phlebitis Nervousness Anxiety Oesophagitis Agranulocytosis Hepatitis Urticaria Avascular necrosis of bone Rash maculo-papular Pruritus Avascular necrosis of bone Hepatocellular damage Dermatitis Gastritis Blepharitis

No No No No No No No No No No No No No No No No No No No No No No No No No No

Male Male Male Male Female Male Male Male Female

Probable 200 mg Rectal Hospital Probable 200 mg Rectal Hospital Probable 200 mg Rectal Hospital Probable 200 mg Rectal Hospital Probable 75 mg Certain Certain Certain Probable 1 MIU 1 MIU 1 MIU 1 DF 1 DF 5 ml Oral Hospital IM IM IM GP GP GP

8 8 8 8 42 60 60 60 34 34 20 54 74 75 26 14 42 72 76 28 28 40 55 9 57 57

128 1989 C07FA05 1989 C07FA05 129 1989 D08AC02 130 1989 R03DA05 131 1989 132 1989 J01EE07 J01CE08

Oral Hospital Oral Hospital Dental IV Oral IM GP SP SP Hospital GP

Female Not recovered Probable Male Male Female Female Female Female Male Male Not recovered Recovered Recovered NA Probable

Probable 240 mg Possible Certain 4 DF 1 DF

133 1989 J01AA02 134 1988 N02BB02 135 1988 A02BA02 136 1988 A07EC01 137 1989 B01AB01 138 1989 N03AF01 1989 N03AF01 139 1989 B01AB01 140 1989 C07FA05 141 1989 N03AB02 142 1989 C07AB13 1989 C07AB13

Recovered w. Probable 100 mg Oral sequaelae Recovered Recovered Recovered Not recovered Recovered Recovered Not recovered Not recovered Recovered Not recovered Possible Probable Probable Certain Probable Probable 3g 2g 3g 5 kIU 3 DF 3 DF

Oral Hospital Oral Hospital Oral Hospital SC Oral Oral SC Hospital SP SP Hospital

Malignant neoplasm Female of rectum Epilepsy Epilepsy NA Hypertension Epilepsy Hypertension Hypertension Female Female Male Female Male Female

Probable 10 kIU Probable 3.5 DF

Oral Hospital

Probable 150 mg Oral Hospital Probable 100 mg Oral GP GP

Female Not recovered Probable 100 mg Oral

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72
1989 C07AB13 1989 C07AB13 1989 C07AB13 1989 C07AB13 143 1989 V08AB05 1989 V08AB05 144 1989 1989 1989 J01FA01 J01FA01 J01FA01 Cordanum Cordanum Cordanum Cordanum Ultravist Ultravist Etromycin Etromycin Etromycin Leponex Ketazon Piroxicam Piroxicam Depressan Depressan Depressan Doxycycline Doxycycline Sedafamem Convulsofin Depressan Ketazon Ketazon Awelysin Heparin Tiretta analgica p Awelysin Berlicetin Berlicetin Berlicetin Alemoxan Alemoxan GDR GDR GDR GDR Bayer Bayer Orion Orion Orion Novartis CSSR GDR GDR GDR GDR GDR GDR GDR GDR GDR GDR CSSR CSSR GDR GDR Talinolol Talinolol Talinolol Talinolol Iopromide Iopromide Erythromycin Erythromycin Erythromycin Clozapine Kebuzone Piroxicam Piroxicam Dihydralazine Dihydralazine Dihydralazine Doxycycline Doxycycline Phendimetrazine Valproic acid Dihydralazine Kebuzone Kebuzone Streptokinase Heparin Codeine/ papaverin/ aminophenazone/ phenazone Streptokinase Prednisolone/ chloramphenicol Prednisolone/ chloramphenicol Prednisolone/ chloramphenicol Clozapine Clozapine

L. AAGAARD
Conjunctivitis Lacrimation abnormal Rash erythematous Alopecia Thrombophlebitis Embolism pulmonary Hepatocellular damage Sgpt increased Sgot increased Agranulocytosis Hepatitis cholestatic Vision abnormal Accommodation abnormal Hepatitis Sgot increased Sgpt increased Vasculitis allergic Fever Psychosis Thrombocytopenia Hepatitis cholestatic Hepatitis Hepatitis Hepatitis Avascular necrosis of bone Anaphylactic shock Anaphylactic shock Otitis externa Otitis externa Pruritus Agranulocytosis Rhinitis

ET AL.
No No No No No No No No No No No No No No No No No No No No No No No No No Hypertension Hypertension Hypertension Hypertension NA NA NA NA NA Paranoid type schizophrenia Back disorder Systemic lupus erythematous Systemic lupus erythematous Hypertension Hypertension Hypertension NA NA Obesity Epilepsy Hypertension Niple infection Gout Venous embolism NA Female Not recovered Probable 100 mg Oral Female Not recovered Probable 100 mg Oral Female Not recovered Probable 100 mg Oral Female Not recovered Probable 100 mg Oral Female Female Male Male Male Female Female Male Male Male Male Male Female Female Male Male Male Female Female Male Female Recovered w. Certain sequaelae Recovered w. Certain sequaelae Recovered Recovered Recovered Recovered Recovered Recovered recovered Recovered recovered recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Not recovered Recovered Certain Certain Certain 50 ml 50 ml IV IV GP GP GP GP Hospital Hospital 57 57 57 57 48 48 2 2 2 24 66 43 43 53 53 53 40 40 40 12 55 25 49 NA 29

360 mg Oral Hospital 360 mg Oral Hospital 360 mg Oral Hospital

145 1989 N05AH02 146 1989 M01AA06 147 1989 M01AC01 1989 M01AC01 148 1989 C02DB01 1989 C02DB01 1989 C02DB01 149 1989 J01AA02 1989 J01AA02 150 1989 A08A A

Probable 200 mg Oral Hospital Probable 10 ml IM Hospital

Probable 20 mg Probable 20 mg Probable Probable Probable Probable Probable Certain Certain Certain 2 DF 2 DF 2 DF 0.1 g 0.1 g 2 DF 3 DF 75 mg

Oral Hospital Oral Hospital Oral Oral Oral SP SP SP

Oral Hospital Oral Hospital Oral GP

151 1989 N03AG01 152 1989 C02DB01 153 1989 M01AA06 1989 M01AA06 154 1989 B01AD01 155 1989 B01AB01

Oral Hospital Oral GP

Probable 250 mg Oral Hospital Probable 750 mg Oral Hospital Probable 3 MIU Probable 10 kIU IV SC Oral Hospital

156 1989 N02AC03

GDR

No

Migraine Acute myocardial infection Ear disorder Ear disorder Ear disorder Paranoid states Paranoid states

Female

Probable

4 ml

IV

GP

26

157 1989 B01AD01 158 1989 S03AA08 159 1989 S03AA08 1989 S03AA08 160 1989 N05AH02 1989 N05AH02

GDR GDR GDR GDR GDR GDR

No No No No No No

Male Female Male Male Female Female

NA Recovered Recovered Recovered Not recovered Not recovered

Probable 0.2 MIU Certain Certain Certain 1 ml 1 ml 1 ml

IV Top. Top. Top.

Hospital SP SP SP

47 50 33 33 38 38

Probable 200 mg Oral Hospital Probable 200 mg Oral Hospital

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L. AAGAARD
1989 N05AH02 1989 N05AH02 161 1989 A07EC01 1989 A07EC01 1989 A07EC01 1989 A07EC01 162 1989 M01CB01 1989 M01CB01 163 1989 N03AF01 164 1989 A02BA01 165 1989 166 J01GB03 J01CE01 Alemoxan Alemoxan Sulfasalazin Sulfasalazin Sulfasalazin Sulfasalazin Tauredon Tauredon Finlepsin Altramet Gentamicin Penicillin g Sombrevin Sombrevin Sombrevin Awelysin Awelysin Awelysin Awelysin Awelysin Corinfar Rifampicin Rifampicin Rifampicin Depressan Depressan Depressan Depressan Heparin Heparin Heparin Rifampicin GDR GDR Yugoslavia Yugoslavia Yugoslavia Yugoslavia Byk Gulden Byk Gulden GDR GDR Bulgaria GDR Hungary Hungary Hungary GDR GDR GDR GDR GDR GDR Rumania Rumania Rumania GDR GDR GDR GDR GDR GDR GDR Rumania Clozapine Clozapine Sulfasalazine Sulfasalazine Sulfasalazine Sulfasalazine Aurothiomalate Aurothiomalate Carbamazepine Cimetidine Gentamicin Benzylpenicillin Propanidid Propanidid Propanidid Streptokinase Streptokinase Streptokinase Streptokinase Streptokinase Nifedipine Rifampicin Rifampicin Rifampicin Dihydralazine Dihydralazine Dihydralazine Dihydralazine Heparin Heparin Heparin Rifampicin Bronchitis Rash pustular Rash erythematous Sgot increased Sgpt increased Leukocytosis Purpura Trombocytopenia Hepatorenal syndrome Gynaecomastia Deafness Anaphylactic shock Thrombophlebitis Thrombophlebitis Thrombophlebitis Dizziness Flushing Headache Hypertension Sweating increased Taste perversion Nausea Purpura Trombopenia Anxiety Depression Hypertension Vision abnormal Nausea Vision abnormal Vomiting Renal failure acute

ET AL.
No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No No Paranoid states Paranoid states Ulcerative colitis Ulcerative colitis Ulcerative colitis Ulcerative colitis Rheumatoid arthritis Rheumatoid arthritis Convulsions Oesophagitis Fracture of ribs NA Phlebitis Phlebitis Phlebitis Phlebitis Phlebitis Phlebitis Phlebitis Phlebitis Hypertension NA NA NA Hypertension Hypertension Hypertension Hypertension NA NA NA NA Female Female Male Male Male Male Female Female Not recovered Not recovered Recovered Recovered Recovered Recovered Recovered Recovered Probable 200 mg Oral Hospital Probable 200 mg Oral Hospital Probable Probable Probable Probable Certain Certain 3.5 g 3.5 g 3.5 g 3.5 g 220 mg 220 mg Oral Hospital Oral Hospital Oral Hospital Oral Hospital IM IM Hospital Hospital

73
38 38 52 52 52 52 73 73 4 62 48 24 51 38 36 66 66 66 66 66 49 41 41 41 34 34 34 34 83 83 83 57

Male Not recovered Possible 1.5 DF Male Male Female Female Female Female Male Male Male Male Male Male Female Female Female Female Female Female Female Male Male Male Male Recovered Not recovered Recovered Probable 1g

Oral Hospital Oral Hospital IV IV NA NA NA IV IV IV IV IV NA Oral Oral Oral Oral Oral Oral Oral SC SC SC Oral Hospital Hospital Hospital Hospital Hospital Hospital Hospital Hospital Hospital Hospital GP SP SP SP GP GP GP GP Hospital Hospital Hospital SP

Probable 120 mg Certain 5 ml NA NA NA 1 MIU 1 MIU 1 MIU 1 MIU 1 MIU NA NA NA NA

1990

167 1990 N01AX04 168 1990 N01AX04 169 1990 N01AX04 170 1990 B01AD01 1990 B01AD01 1990 B01AD01 1990 B01AD01 1990 B01AD01 171 1990 C08CA05 172 1990 1990 1990 J04AB02 J04AB02 J04AB02

Recovered w. Probable sequaelae Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Recovered Probable Probable Certain Certain Certain Certain Certain Probable Possible Possible Possible

173 1990 C02DB01 1990 C02DB01 1990 C02DB01 1990 C02DB01 174 1990 B01AB01 1990 B01AB01 1990 B01AB01 175 1990 J04AB02

Probable 25 mg Probable 25 mg Probable 25 mg Probable 25 mg Possible 15 kIU Possible 15 kIU Possible 15 kIU Possible NA

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74
176 1990 1990 1990 1990 177 1990 J01FA01 J01FA01 J01FA01 J01FA01 J01CE01 Lubomycin-b Lubomycin-b Lubomycin-b Lubomycin-b Jenacillin-a Halan Halan Halan Halan Calcium dobesilate Calcium dobesilate Pavulon Pavulon Poland Poland Poland Poland GDR GDR GDR GDR GDR GDR GDR Organon Teknica Organon Teknica Erythromycin Erythromycin Erythromycin Erythromycin Benzylpenicillin Halothane Halothane Halothane Halothane Calcium dobesilate Calcium dobesilate Pancuronium Pancuronium

L. AAGAARD
Hepatitis cholestatic Hepatomegaly Sgot increased Sgpt increased Dizziness Hepatic function abnormal Hepatitis Eosinophilia Prothrombin decreased Injection site reaction Calcinosis Bradycardia Cardiac arrest

ET AL.
No No No No No No No No No No No Yes Yes NA NA NA NA Erysipelas NA NA NA NA Abnormal blood chemistry Abnormal blood chemistry NA NA Female Female Female Female Male Male Male Male Male Female Female Male Male NA NA NA NA Recovered Recovered Recovered Recovered Recovered Not recovered Not recovered Died Died Probable Probable Probable Probable NA NA NA NA Oral Hospital Oral Hospital Oral Hospital Oral Hospital IM Hospital 3 3 3 3 54 49 49 49 49

Probable 2 MIU Certain Certain Certain Certain Certain Certain Possible Possible 1 times 1 times 1 times 1 times 20 ml 20 ml mg .4 mg

178 1990 N01AB01 1990 N01AB01 1990 N01AB01 1990 N01AB01 179 1990 A12AA06 1990 A12AA06 180 1990 M03AC01 1990 M03AC01

INH Hospital INH Hospital INH Hospital INH Hospital IV IV IC IC

Hospital 3 mo. Hospital 3 mo. Hospital 5 mo. Hospital 5 mo.

Abbreviations
GP: general practitioner; SP: specialist physician; DF: defined formulation; mo.: months; IV: intravenous; IA: intraarteriel; IM: intramuscular; SC: subcutaneous; INH: inhalation; Top: topical; IC: intracardiac; BRD: Bundesrepublic Deutschland; CSSR: Czechoslovak Socialist Republic.

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