therapeutic goods administration public case detail · 2017. 3. 15. · date range: 28 mar 1991 to...

Date Range: 28 Mar 1991 To 18 Jul 2007 Unclear causality excluded GM medicines Only Tradenames: ORAP,PIMOZIDE

THERAPEUTIC GOODS ADMINISTRATION Public Case Detail

Report Run : 04/06/2007 12:07PM Database: pusime02 ADRS004 Page 1 of 22

Case Number: Gender:Weight:

Case Sequenced to: 70947/2

22/05/1991

22/04/1991Causality probableRecovered

DOB:Causality:

MReported:

Onset Date:Outcome:

Reaction Details:

Date Type Range Date Tested Result DetailsLaboratory Investigations:

59YAge:

Additional Information:

Medicine Details:Unspecified psychosis

Stopped:Started:Batch:

Milligram Daily OralTablet 2.0

PIMOZIDE (Suspected)

22/04/1991

Reason:

Hospitalisation:

Report Details:Seq: 12623

Preferred Term Severity Report Description TreatmentExtrapyramidal disorder




Case Number: Gender:43.00Weight:

the dosage start date is not necessarily accurate but indicates that start occurred sometime during the month. the dosage stop date is not necessarily accurate but indicates that stoppage occurred sometime during the month.

28/03/1991

Causality probableUnknown23/02/1966DOB:

Causality:

FReported:

Onset Date:Outcome:

Reaction Details:

Date Type Range Date Tested Result Details

Electrographics 19/3/91-sinus rhythm 100/min. st-t wave changes in inferior leads are abnormal. mild st segment depression in v3-v6 and lead i.

Laboratory Investigations:

25Age:


Medicine Details:Unspecified schizophrenia


Milligram Daily4.0


01/11/1990 28/03/1991

Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentElectrocardiogram abnormal





Bilateral bifid thumbs (complete polydactyly thumbs) of baby of mother with past history of schizophrenia on these medications prior to pregnancy. no treatment during pregnancy.

18/02/1993

Causality possibleNot yet recoveredDOB:

Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


Age:




0.0

MODECATE (Suspected) Reason:

Unspecified schizophrenia


0.0

SERENACE (Suspected) Reason:

Unspecified schizophrenia


0.0

PIMOZIDE (Suspected) Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentPolydactyly





Patient had been on orap 4mg daily for several months. symptoms began about 1 week after increasing the dose

14/02/1994

29/01/1994Causality possibleNot yet recovered

DOB:Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


Prolactin




Case Number: Gender:Weight:17/05/1994

18/11/1993Causality possibleRecovered02/10/1932DOB:

Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


61Age:


Medicine Details:


Microgram As necessary500.0

CLONAZEPAM (Suspected)

09/11/1993 CONTIN

Reason:


Milligram Daily30.0

PHENELZINE SULPHATE (Suspected)

02/11/1993

Reason:


Milligram Daily30.0

PHENELZINE SULPHATE (Suspected)

16/11/1993 CONTIN

Reason:


Milligram Daily2.0


03/11/1993 CONTIN

Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentHypertension





05/10/1994Causality possibleRecovered

DOB:Causality:

MReported:

Onset Date:Outcome:

Reaction Details:


74YAge:


Medicine Details:


Milligram OralTablet 30.0

ISOSORBIDE DINITRATE (Other drug)

CONTIN

Reason:



SIMVASTATIN (Other drug)

CONTIN

Reason:


Milligram Daily240.0

VERAPAMIL HYDROCHLORIDE (Other drug)

CONTIN

Reason:


Milligram Daily15.0

OXAZEPAM (Other drug)

CONTIN

Reason:

Hospitalisation: Admitted to hospital


Preferred Term Severity Report Description TreatmentAstheniaDystoniaFatigue Commenced cogentin.






DOB:Causality:

MReported:

Onset Date:Outcome:

Reaction Details:


74YAge:


Medicine Details:



ORAP (Suspected)

28/09/1994 05/10/1994

Reason:






Case Number: Gender:56.00Weight:13/12/1994


DOB:Causality:

MReported:

Onset Date:Outcome:

Reaction Details:


49YAge:


Medicine Details:Aids



DAPSONE (Other drug)

07/05/1994

Reason:

Aids



ZALCITABINE (Other drug) Reason:

Aids


Gram Daily OralTablet 2.0

CLARITHROMYCIN (Other drug)

26/05/1994

Reason:

Aids


Milligram Daily OralOral application 300.0

RIFABUTIN (Other drug)

27/05/1994

Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentRash maculo-papular






DOB:Causality:

MReported:

Onset Date:Outcome:

Reaction Details:


49YAge:


Medicine Details:


Million International UnitsDaily IntravenousInjection 24.0

BENZYLPENICILLIN (Suspected)

13/06/1994 22/06/1994

Reason:

Unspecified psychosis


Milligram Daily4.0


18/06/1994 22/06/1994

Reason:

Hospitalisation:







DOB:Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


21YAge:


Medicine Details:Depression



AROPAX (Suspected)

13/01/1995

Reason:

Depression



AROPAX (Suspected)

01/03/1995 05/04/1995

Reason:



COGENTIN (Suspected)

16/08/1994

Reason:


Gram Daily OralTablet 1.0

LITHIUM CARBONATE (Suspected)

20/09/1994

Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentAlopecia






DOB:Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


21YAge:


Medicine Details:




20/10/1994

Reason:



THIORIDAZINE HYDROCHLORIDE (Suspected)

07/12/1992

Reason:

Hospitalisation:






the dosage start date is not necessarily accurate but indicates that start occurred sometime during the month.

14/07/1997


DOB:Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


93YAge:





AURORIX (Other drug)

01/11/1996

Reason:

Hallucinations


Dose Unspecified Daily OralTablet 2.0

ORAP (Suspected)

05/06/1997 19/06/1997

Reason:



Preferred Term Severity Report Description TreatmentNeuroleptic malignant syndrome





- the date of onset is not necessarily accurate but indicates that onset occurred sometime during the month.

02/10/1997


DOB:Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


71YAge:


Medicine Details:Essential benign hypertension


Milligram Daily OralOral application 25.0

ATENOLOL (Other drug) Reason:

Essential benign hypertension



APRINOX (Other drug) Reason:

Essential benign hypertension



SLOW-K (Other drug) Reason:


Milligram Daily2.0

PIMOZIDE (Suspected) Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentExtrapyramidal disorder Marked parkinsonium side effects





25/09/1997Causality possibleUnknown

DOB:Causality:

MReported:

Onset Date:Outcome:

Reaction Details:


73YAge:


Medicine Details:



SINEMET (Other drug)

CONTIN

Reason:


0.0


25/09/1997

Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentHallucination Pimozide ceased, olanzapine

started.





Orap reducing because of recovery from psychotic features. story fits a cramping muscle pain from psychotropic. the dosage start date is not necessarily accurate but indicates that start occurred sometime during the month. the dosage start date is not necessarily accurate but indicates that start occurred sometime during the month. the dosage start date is not necessarily accurate but indicates that start occurred sometime during the month.

18/01/1999


DOB:Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


38YAge:




Milligram Daily375.0

EFEXOR (Other drug)

01/09/1998 CONTIN

Reason:



PINDOLOL (Other drug)

01/09/1998 CONTIN

Reason:



ORAP (Suspected)

01/09/1998 21/01/1999

Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentPain Pubococcygeal pain Quinine given & reduced

pelvic floor exercises.Muscle spasms





See original report for details of other drugs: timolol, inderal, xalaten. the dosage start date is not necessarily accurate but indicates that start occurred sometime during the month.

31/08/1999


DOB:Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


78YAge:


Medicine Details:


Milligram Daily2.0

ORAP (Suspected)

01/03/1999 26/06/1999

Reason:



Preferred Term Severity Report Description TreatmentSyncope Recurrent falls right knee pain Ceased orap.





Other drugs prescribed: 'antibiotics'& steroids 2 weeks early trimester one. teratogenic effect right hand - absent middle and ring fingers, hypoplastic index finger, hypoplastic little finger and possibly mildly small thumb.

18/06/2001

Causality possibleNot yet recoveredDOB:

Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


Other data Absent middle and ring fingers, hypoplastic index finger, hypoplastic little finger and possibly mildly small thumb.


ADAge:


Medicine Details:


0.0

ZOLOFT (Suspected) Reason:


0.0

ORAP (Suspected) Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentCongenital hand malformation





Causality probableRecovered05/10/1933DOB:

Causality:

MReported:

Onset Date:Outcome:

Reaction Details:


69Age:


Medicine Details:Lichenifica&lich simplex chron



ORAP (Suspected)

15/06/2003 09/07/2003

Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentExtrapyramidal disorder Patient experienced extrapyramidal type

symptoms including salivation, loss of facial expression, difficult waking and tremor.

Orap ceased.

Gait disturbanceSalivary hypersecretionTremor





J.Forensic Science 1997, 42(5): 951-953.

14/04/2004

Causality possibleDeathDOB:

Causality:

MReported:

Onset Date:Outcome:

Reaction Details:


14/04/2004 Biochemistry14/04/2004 Haematology14/04/2004 Other data


22Age:


Medicine Details:


MOCLOBEMIDE (Interaction) Reason:


SERTRALINE HYDROCHLORIDE (Interaction) Reason:


PIMOZIDE (Interaction) Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentDrug interaction Drug interaction, drug toxicity due to

intentional overdose, death.Given Charcoal.

DeathDrug toxicityIntentional overdose





Causality possibleUnknownDOB:

Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


99UAge:


Medicine Details:




Hospitalisation:


Preferred Term Severity Report Description TreatmentTardive dyskinesia Patient developed tardive dyskinesia. Stopped Orap





15/09/2005Causality possibleRecovered 15/11/200530/05/1954DOB:

Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


51Age:





ORAP (Suspected)

L TERM

Reason:

Hospitalisation:


Preferred Term Severity Report Description TreatmentBreast cyst Patient developed breast cyst whilst on

Orap.





Reporter indicated tha the patient has had a history of depression possibly caused by other medications.

31/08/2006

Causality possibleUnknownDOB:

Causality:

FReported:

Onset Date:Outcome:

Reaction Details:


99uAge:


Medicine Details:


METFORMIN HYDROCHLORIDE (Other drug) Reason:




Hospitalisation:


Preferred Term Severity Report Description TreatmentDepression Incapacity/dis

abilityDepression.

26231

702521

826681

910641

931251

969261

969261

977821

977821

1007141

1007141

1190371

1212881

1230391

1351921

1433171

1659771

1887831

1964671

2098191

2123551

2212571

therapeutic goods administration public case detail · 2017. 3. 15. · date range: 28 mar 1991 to...

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