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FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:03/03/98ISR Number: 3040331-3Report Type:Expedited (15-DaCompany Report

#94236 Age:37 YR Gender:Male

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Death Blood Amylase Increased Foreign

Bactrim Forte PS ORAL 480 MG 1 X

Hospitalization - Blood Creatinine Other

PER DAY ORAL

Initial or Prolonged Increased

Zelitrex SS ORAL 500 MG 6 X

Blood Urea Increased

PER DAY ORAL

Lipase Increased

Forlax SS ORAL 10 GRAM 6 X

Lymphoma

PER DAY ORAL

Pancreatitis Mag

2 SS ORAL 2.250 MG 2 X

PER DAY ORAL

Zovirax SS INTRAVENOUS 600 MG 3 X

PER DAY

INTRAVENOUS

Skenan Lp SS ORAL 20 MG 2 X PER

DAY ORAL

Date:03/16/98ISR Number: 3056047-3Report Type:Expedited (15-DaCompany Report

#94236 Age:37 YR Gender:Male

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Death Abdominal Pain Foreign

Bactrim Forte PS ORAL 480.0000 MG

Hospitalization - Blood Amylase Increased Other

1.0 X PER DAY

Initial or Prolonged Blood Creatinine

ORAL

Increased

Zelitrex SS ORAL 500.0000 MG

Blood Urea Increased

6.0 X PER DAY

Herpes Zoster Mag

2 SS ORAL 2.500 MG 2.0

Ileus Paralytic

X PER DAY

Lipase Increased

ORAL

Lymphoma Aids Related

Forlax SS ORAL 10.0000 GRAM

Pancreatitis

6.0 X PER DAY

ORAL

Zovirax SS INTRAVENOUS 600.0000 MG

3.0 X PER DAY

INTRAVENOUS

Invirase SS

Skenan Lp SS ORAL 20.0000 MG

2.0 X PER DAY

ORAL

Norvir C

Zerit C

Epivir C

Date:12/07/00ISR Number: 3625146-7Report Type:Expedited (15-DaCompany Report

#2000CG00794 Age:62 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Required Angioedema Foreign

Zestoretic PS Astrazeneca

Intervention to Drug Interaction Health

Pharmaceuticals Lp ORAL 20 MG DAILY

Prevent Permanent Professional

PO ; 12.5 MG

Impairment/Damage Other

DAILY PO;

Polyethylene Glycol SS

Atenolol C

Ibuprophene C

Lipur C

17-Mar-2008 02:37 PM

Page: 1

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:12/14/00ISR Number: 3630380-6Report Type:Expedited (15-DaCompany Report

#2000CG00794 Age:62 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Required Angioedema Foreign

Zestoretic PS Astrazeneca

Intervention to Drug Interaction Health

Pharmaceuticals Lp ORAL 20 MG DAILY

Prevent Permanent Professional

PO

Impairment/Damage Other

Zestoretic SS ORAL 12.5 MG DAILY

PO

Polyethylene Glucol SS

Atenolol C

Ibkuprophene C

Lipur C

Date:06/13/03ISR Number: 4128771-2Report Type:Direct Company Report

#CTU 195765 Age:11 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Petechiae

Polyethylene Glycol

(Nulytely) PS NASAL 500ML PER

HOUR NG

Date:12/21/04ISR Number: 4534019-7Report Type:Direct Company Report

#CTU 234768 Age:89 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Dyspepsia

Polyethylene Glycol

Pharmaceutical Product 3350

Pwd 527g; PS MIX AND TAKE

Complaint

1

TABLESPOONFUL

IN 8 OUNCES

OF WATER

Date:02/08/05ISR Number: 4576969-1Report Type:Expedited (15-DaCompany Report

#050005 Age: Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Bipolar Disorder Consumer

Polyethylene Glucol

Suicide Attempt

3350, Nf Powder For

Solution PS

Bipolar Medication C

Date:02/10/05ISR Number: 4580080-3Report Type:Expedited (15-DaCompany Report

#050005 Age:17 YR Gender:Male

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Suicide Attempt Consumer

Polyethylene Glycol

3350, Nf Powder For

Solution PS ORAL 17G/BID (AM &

PM) /PO

Bipolar Medication

(Believed To Be A

Combination Therapy

Of

Tryptanol &

Propec) C

17-Mar-2008 02:37 PM

Page: 2

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:02/18/05ISR Number: 4590517-1Report Type:Direct Company Report

#CTU 240823 Age:76 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Constipation

Polyethylene Gi 3350

Drug Ineffective Pwd

527 G Affordable

Pharmaceutical Product

Pharm PS Affordable Pharm 1 SCOOP DAILY

Complaint

Zocor C

Niaspan Er C

Advair Diskus C

Date:03/01/05ISR Number: 4598119-8Report Type:Direct Company Report

#CTU 241748 Age:73 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Drug Effect Decreased

Polyethylene Gi 3350

Pwd

527g Affordable

Pharm PS Affordable Pharm ORAL 17 GMS PO

Q./8 OUNCES

WATER DAILY

Date:03/11/05ISR Number: 4679636-9Report Type:Direct Company Report

#CTU 243038 Age: Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Abdominal Pain

Polyethylene Glycol PS 1/2 CAPFUL QD

Diarrhoea

Pharmaceutical Product

Complaint

Skin Irritation

Date:03/30/05ISR Number: 4624348-0Report Type:Direct Company Report

#CTU 244780 Age: Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Abdominal Pain

Polyethylene Glycol PS ORAL 1 CAPFUL QD

Diarrhoea

ORALLY

Flatulence

Incontinence

Pain

Pharmaceutical Product

Complaint

Date:03/31/05ISR Number: 4656630-5Report Type:Periodic Company Report

#US100455 Age:56 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Chest Discomfort Health

Neulasta - Prefilled

Discomfort Professional

Syringe PS INTRAVENOUS 6 MG, 1 IN 1

Flushing

DAYS, IV

Hypotension

Polyethylene Glycol SS

Medication Error

Cyclophosphamide C

Tachycardia

Doxorubicin

Hydrochloride C

Vincristine Sulfate C

Prednisone C

Rituximab C

17-Mar-2008 02:37 PM

Page: 3

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:05/04/05ISR Number: 4654512-6Report Type:Direct Company Report

#CTU 247767 Age:83 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Drug Effect Decreased

Polyethylene Glycol

Pharmaceutical Product 3350

Pwd 527g PS Affordable Pharm MIX ONE

Complaint

CAPFUL (17

Therapeutic Response

GRAMS) IN 80Z

Unexpected With Drug

OF WATER AND

Substitution

DRINK AS

Carbidopa/Levo C

Lexapro C

Warfarin C

Date:06/17/05ISR Number: 4693902-2Report Type:Expedited (15-DaCompany Report

#FR-MERCK-0506FRA00047 Age:93 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Life-Threatening Abdominal Mass

Zocor PS Merck & Co., Inc ORAL

140 DAY

Hospitalization - Acute Myocardial

Polyethylene Glycol

Initial or Prolonged Infarction 4000

SS ORAL

Arrhythmia

Sodium Phosphate,

Cardio-Respiratory Arrest

Dibasic And Sodium

Cardiogenic Shock

Phosphate, Monobasic SS ORAL

2 DAY

Dehydration

Bisoprolol Fumarate SS ORAL

Diarrhoea

Aspirin Lysine C ORAL

Disease Recurrence

Hypernatraemia

Hypokalaemia

Iron Deficiency Anaemia

Thrombosis In Device

Ventricular Arrhythmia

Date:06/20/05ISR Number: 4695090-5Report Type:Expedited (15-DaCompany Report

#FR-MERCK-0506FRA00047 Age:93 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Death Acute Myocardial

Zocor PS Merck & Co., Inc ORAL

140 DAY

Life-Threatening Infarction

Polyethylene Glycol

Hospitalization - Cardio-Respiratory Arrest 4000

SS ORAL

Initial or Prolonged Cardiogenic Shock

Sodium Phosphate,

Dehydration

Dibasic And Sodium

Diarrhoea

Phosphate, Monobasic SS ORAL

2 DAY

Hypernatraemia

Bisoprolol Fumarate SS ORAL

Hypokalaemia

Aspirin Lysine C ORAL

Thrombosis In Device

Ventricular Arrhythmia

Date:07/21/05ISR Number: 4724563-1Report Type:Expedited (15-DaCompany Report

#211352 Age:63 YR Gender:Male

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Death Hepatitis B Foreign

Rituxan (Rituximab)

Health Conc

For Solution

Professional For

Infusion PS INTRAVENOUS 570 MG

Other

INTRAVENOUS

Methotrexate

(Methotrexate) SS INTRAVENOUS 4860 MG

INTRAVENOUS

17-Mar-2008 02:37 PM

Page: 4

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Bleomycin (Bleomycin

Sulfate) SS INTRAVENOUS 6.5 MG

INTRAVENOUS

Doxorubicin

Hydrochloride(Doxoru

bicin Hydrochloride) SS INTRAVENOUS 73 MG

INTRAVENOUS

Cyclophosphamide

(Cyclophosphamide) SS INTRAVENOUS 1000 MG

INTRAVENOUS

Vincristien

(Vincristine

Sulfate) SS INTRAVENOUS 1.6 MG

INTRAVENOUS

Dexamethasone Sodium

Phosphate

(Dexamethasone

Sodium Phosphate) SS INTRAVENOUS 10 MG

INTRAVENOUS

Human Serum Albumin

(Albumin Human) SS INTRAVENOUS 12.5 G

INTRAVENOUS

Polyethylene Glycol

(Polyethyline

Glycol) SS INTRAVENOUS 5 MG

INTRAVENOUS

Loxonin (Loxoprofen

Sodium) C

Polaramine

(Dexchlorpheniramine

Maleate) C

Date:12/14/05ISR Number: 4856241-2Report Type:Direct Company Report

#CTU 265037 Age:84 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Therapeutic Response

Polyethylene Glycol

Unexpected With Drug 3350

Pwd 527g PS Affordable

Substitution

Pharmaceuticals MIX AND DRINK

1 CAPFUL

TWICE A DAY

(DURATION:

APPROX ONE 1 YR

Plavix C

Singulair C

Zocor C

Quinine Sulfate C

Benicar C

Date:04/17/06ISR Number: 4978854-XReport Type:Expedited (15-DaCompany Report

#211352 Age:63 YR Gender:Male

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Death Blood Pressure Decreased Foreign

Rituxan (Rituximab)

Coma Hepatic Health Conc

For Solution

Hepatitis B Professional For

Infusion PS INTRAVENOUS 570 MG,

Hepatitis Fulminant Other

INTRAVENOUS

Platelet Count Decreased

Methotrexate

Pneumonia

(Methotrexate) SS INTRAVENOUS 4860 MG,

17-Mar-2008 02:37 PM

Page: 5

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

INTRAVENOUS

Bleomycin (Bleomycin

Sulfate) SS INTRAVENOUS 6.5 MG,

INTRAVENOUS

Doxorubicin

Hydrochloride

(Doxorubicin

Hydrochloride) SS INTRAVENOUS 73 MG,

INTRAVENOUS

Cyclophosphamide

(Cyclophosphamide) SS INTRAVENOUS 1000 MG,

INTRAVENOUS

Vincristine

(Vincristine

Sulfate) SS INTRAVENOUS 1.6 MG,

INTRAVENOUS

Dexamethasone Sodium

Phosphate

(Dexamethasone

Sodium Phosphate) SS INTRAVENOUS 10 MG,

INTRAVENOUS

Human Serum Albumin

(Albumin Human) SS INTRAVENOUS 12.5 MG,

INTRAVENOUS

Polyethylene Glycol

(Polyethylene

Glycol) SS INTRAVENOUS 5 MG,

INTRAVENOUS

Loxonin (Loxoprofen

Sodium) C

Polaramine

(Dexchlorpheniramine

Maleate) C

Date:04/26/06ISR Number: 5026389-0Report Type:Periodic Company Report

#2006002810 Age: Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Asthenia Consumer

Lyrica (Pregabalin) PS

Diarrhoea

Polyethylene Glycol

Drug Interaction

(Polyethylene

Oedema Peripheral

Glycol) SS

Actos (Pioglitazone) SS

Date:05/18/06ISR Number: 5008714-XReport Type:Expedited (15-DaCompany Report

#2006002810 Age:78 YR Gender:Female

I/FU:I

Outcome PT

Hospitalization - Asthenia

Initial or Prolonged Cataract

Other Diarrhoea

Drug Interaction

Fatigue

Hypotension

Impaired Healing

Ingrowing Nail

Lethargy

Loss Of Consciousness

Oedema Peripheral

Overdose

17-Mar-2008 02:37 PM

Page: 6

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Pain In Extremity

Therapy Regimen Changed

Vision Blurred Report Source

Product Role Manufacturer Route Dose

Duration

Consumer

Lyrica (Pregabalin) PS

Polyethylene Glycol

(Polyethylene

Glycol) SS

Actos (Pioglitazone) SS

Oxycontin (Oxycodone

Hydrochloride) SS

All

Other

Therapeutic Products

(All

Other

Therapeutic

Products) SS

Toprol (Metoprolol) C

Mavik (Trandolapril) C

Date:06/06/06ISR Number: 5021014-7Report Type:Direct Company Report

#CTU 278276 Age:57 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Dysgeusia

Polyethylene Glycol PS Affordable Pharm OPHTHALMIC ONE SCOOP

Infrequent Bowel

MIXED WITH

Movements

LIQUID BY

Pharmaceutical Product

MOUTH DAILY

Complaint

Date:06/23/06ISR Number: 5034526-7Report Type:Direct Company Report

#CTU 279367 Age:77 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Abdominal Pain Upper

Polyethylene Gi 3350

Dysgeusia Pwd

527g PS Affordable

Pharmaceutical Product

Pharmaceutical TAKE ONE

Complaint

CAPFUL DAILY 6 WK

Date:08/03/06ISR Number: 5070965-6Report Type:Direct Company Report

#CTU 282258 Age:69 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Constipation

Polyethylene Gi 3350

Pharmaceutical Product Pwd

527g PS Teva MIX AND DRINK

Complaint

17GM (1

CAPFUL) IN

8OZ OF WATER

DAILY

Activella C

Hydrocodone Bit/Apap C

Effexor Xr C

Hydroxychloroquine C

Lorazepam C

Bellamine-S C

Levoxyl C

17-Mar-2008 02:37 PM

Page: 7

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:08/03/06ISR Number: 5070968-1Report Type:Direct Company Report

#CTU 282259 Age:51 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Bowel Movement

Polyethylene Gi 3350

Irregularity Pwd

527g PS Teva MIX 1 TO 2

Diarrhoea

CAPFULS INTO

Drug Ineffective

8 OUNCES OF

Dysgeusia

WATER AS

Flatulence

DIRECTED,

Gastrointestinal Disorder

Paroxetine C

Pharmaceutical Product

Complaint

Date:08/03/06ISR Number: 5070970-XReport Type:Direct Company Report

#CTU 282260 Age:10 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Inappropriate Schedule Of

Polyethylene Glycol

Drug Administration 3350

PS 1 CAPFUL (17

Pharmaceutical Product

GRAMS) DAILY

Complaint

Date:08/03/06ISR Number: 5070979-6Report Type:Direct Company Report

#CTU 282261 Age:69 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Drug Ineffective

Polyethylene Glycol

Nausea 3350

Powder PS Teva 1 HEAPING

Pharmaceutical Product

TABLESPOONFUL

Complaint

IN WATER

Therapeutic Response

Unexpected With Drug

Substitution

Date:08/03/06ISR Number: 5071230-3Report Type:Direct Company Report

#CTU 282255 Age:50 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Pharmaceutical Product

Polyethylene Gi 3350

Complaint Pwd

527q Teva PS MIX AS

DIRECTED AND

DRINK 2

CAPFULS DAILY

Date:08/03/06ISR Number: 5071254-6Report Type:Direct Company Report

#CTU 282257 Age:65 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Pharmaceutical Product

Polyethylene Glycol

Complaint 3350

Powder Teva PS Teva ORAL 17GM BY MOUTH

DAILY IN

WATER

17-Mar-2008 02:37 PM

Page: 8

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:08/15/06ISR Number: 5082087-9Report Type:Direct Company Report

#CTU 282967 Age:50 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Life-Threatening Dyspnoea

Polyethylene Glycol PS Teva ORAL PO

Pharmaceutical Product

Aciphex C

Complaint Hctz

C

Pharyngeal Oedema

Trileptal C

Alprazolam C

Ketoprofen C

Copaxone C

Atenolol C

Cymbalta C

Date:08/23/06ISR Number: 5087641-6Report Type:Direct Company Report

#CTU 283541 Age: Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Headache

Polyethylene Glycol

Pharmaceutical Product

Powder PS 51 GRAMS

Complaint

Throat Irritation

Date:08/23/06ISR Number: 5088139-1Report Type:Direct Company Report

#CTU 283639 Age:56 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Diarrhoea

Polyethylene Glycol

Dysgeusia 3350

Pwd 527 G -Teva PS Teva MIX AND DRINK

Pharmaceutical Product

TWICE A DAY

Complaint

AS DIRECTED

Date:08/30/06ISR Number: 5094834-0Report Type:Direct Company Report

#CTU 284025 Age:15 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Pharmaceutical Product

Polyethylene Gi 3350

Complaint Pwd

527g Teva PS Teva MIX AND DRINK

17GMS TWICE

DAILY

Date:08/30/06ISR Number: 5094835-2Report Type:Direct Company Report

#CTU 284026 Age:48 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Gastrointestinal Disorder

Polyethylene Gi 3350

Pharmaceutical Product Pwd

527 G Teva PS Teva MIX 17 GRAMS

Complaint

(1 CAPFUL) IN

8 OUNCES OF

WATER AND

DRINK AT

17-Mar-2008 02:37 PM

Page: 9

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:09/13/06ISR Number: 5107517-5Report Type:Direct Company Report

#CTU 284937 Age:74 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Drug Intolerance

Polyethylene Gi 3350

Pharmaceutical Product Pwd

527 Q- Teva PS Teva MIX 1 SCOOP

Complaint

(17 GRAMS) IN

8 OZ WATER

AND DRINK

DAILY

Date:09/20/06ISR Number: 5112071-8Report Type:Direct Company Report

#CTU 285353 Age:73 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

No Therapeutic Response

Polyethylene Glycol

Pharmaceutical Product 3350

17gm Pckt Teva PS Teva ORAL MIX AND DRINK

Complaint

1 PACKET

Rash

DAILY WITH

JUICE

Hydrochlorothiazide C

Temazepam C

Potassium Chloride C

Date:09/21/06ISR Number: 5113719-4Report Type:Expedited (15-DaCompany Report

#060164 Age:38 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Required Anaphylactic Reaction Health

Polyethylene Glycol

Intervention to Professional 3350

Nf Powder For

Prevent Permanent

Solution PS

Impairment/Damage

Date:09/21/06ISR Number: 5113771-6Report Type:Direct Company Report

#CTU 285400 Age: Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Diarrhoea

Polyethylene Glycol,

Dysgeusia 3350

Affordable

Pharmaceutical Product

Pharm PS Affordable Pharm 17 GRAMS

Complaint

DAILY 1 YR

Polyethylene Glycol,

3350, Teva Pharm. SS Teva Pharm 17 GRAMS

DAILY

Date:10/10/06ISR Number: 5125947-2Report Type:Direct Company Report

#CTU 286734 Age:56 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Pharmaceutical Product

Polyethylene Gi 3350

Complaint Pwd

527 G - Teva PS Teva MIX AND DRINK

17 GMS DAILY

17-Mar-2008 02:37 PM

Page: 10

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:10/10/06ISR Number: 5125948-4Report Type:Direct Company Report

#CTU 286736 Age:56 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Feeling Jittery

Polyethylene Gi 3350

Pharmaceutical Product

Powder Teva PS Teva MIX AND DRINK

Complaint

17 GM DAILY

Tremor

Date:10/10/06ISR Number: 5125966-6Report Type:Direct Company Report

#CTU 286738 Age:70 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Pharmaceutical Product

Polyethylene Gi 3350

Complaint Pwd

527g; Teva PS Teva MIX AND DRINK

AS DIRECTED 2 YR

Date:10/10/06ISR Number: 5125967-8Report Type:Direct Company Report

#CTU 286740 Age:73 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Pharmaceutical Product

Polyethylene Gi 3350

Complaint Pwd

527g- Teva PS Teva MIX 1 CAPFUL

(17 GRAMS) IN

WATER AND

DRINK TWICE A

DAY CAPFUL (

Date:10/10/06ISR Number: 5125968-XReport Type:Direct Company Report

#CTU 286744 Age:55 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Dysgeusia

Polyethylene Glycol

Nausea 3350

Powder Teva PS Teva 1 SCOOPFUL

Pharmaceutical Product

FOUR TIMES

Complaint

DAILY BY

MOUTH 5 YR

Date:10/10/06ISR Number: 5126101-0Report Type:Direct Company Report

#CTU 286730 Age:78 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Dysgeusia

Polyethylene Gl 3350

Pharmaceutical Product Pwd

527g - Teva PS Teva MIX ONE

Complaint

CAPFUL (17

GRAMS) IN

WATER AND

DRINK DAILY

Date:10/10/06ISR Number: 5126102-2Report Type:Direct Company Report

#CTU 286731 Age:74 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Drug Ineffective

Polyethylene Gl 3350

Pharmaceutical Product Pwd

527g Teva PS Teva MIX AND DRINK

Complaint

AS DIRECTED 2 YR

17-Mar-2008 02:37 PM

Page: 11

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:10/10/06ISR Number: 5126103-4Report Type:Direct Company Report

#CTU 286733 Age:12 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Dysgeusia

Polyethylene Gl 3350

Pharmaceutical Product Pwd

527g - Teva PS Teva MIX 17 GRAMS

Complaint

( 1 CAPFUL)

IN 6 OUNCES

FLUID AND

DRINK DAILY

Date:10/11/06ISR Number: 5128350-4Report Type:Expedited (15-DaCompany Report

#060164 Age:38 YR Gender:Male

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Required Anaphylactic Reaction Health

Polyethylene Glycol

Intervention to Professional

3350, Nf Powder For

Prevent Permanent

Solution PS

Impairment/Damage

Date:10/20/06ISR Number: 5135848-1Report Type:Expedited (15-DaCompany Report

#060176 Age:7 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Abdominal Distension Consumer

Polyethylene Glycol

Abnormal Behaviour

3350, Nf Powder For

Anxiety

Solution PS ORAL 17G, DAILY,

Attention

PO 5 YR

Deficit/Hyperactivity

Magnesium Citrate C

Disorder

Vitamin C C

Fluid Intake Reduced

Fibersure C

Neurological Symptom

Refusal Of Treatment By

Relative

Speech Disorder

Tourette'S Disorder

Weight Increased

Date:11/02/06ISR Number: 5144267-3Report Type:Direct Company Report

#CTU 288473 Age:33 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Anxiety

Polyethylene Glycol

Bowel Movement 3350

Powder 527

Irregularity

Grams Affordable

Diarrhoea

Pharmaceuticals Llc PS Affordable

Dyspepsia

Pharmaceuticals Llc ORAL 2-4

Hypersensitivity

TABLESPOONS

Malaise

1X DAY PO

Muscle Contractions

Involuntary

Pharyngeal Oedema

Pruritus

Urticaria

Vomiting

17-Mar-2008 02:37 PM

Page: 12

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:11/10/06ISR Number: 5152111-3Report Type:Direct Company Report

#CTU 288975 Age:53 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Abdominal Pain Upper

Polyethylene Gl 3350

Diarrhoea Pwd

527g Teva PS Teva UP TO 1

Flatulence

CAPFUL ONCE A

Pharmaceutical Product

DAY

Complaint

Date:11/13/06ISR Number: 5152086-7Report Type:Direct Company Report

#CTU 289211 Age:33 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Dysgeusia

Polyethylene Gi 3350

Odynophagia Pwd

527g Teva PS Teva MIX 17 GRAMS

Pharmaceutical Product

(1 CAPFUL) IN

Complaint

8 OZS OF

Stomatitis

WATER AND

Throat Irritation

DRINK TWICE A

Birth Control C

Date:11/13/06ISR Number: 5152089-2Report Type:Direct Company Report

#CTU 289208 Age: Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Dysgeusia

Polyethylene Glycol

Pharmaceutical Product

Powder Teva PS Teva MIX ONE

Complaint

CAPFUL (17

GRAMS) IN

WATER OR

JUICE AND

Date:11/14/06ISR Number: 5151475-4Report Type:Direct Company Report

#CTU 289311 Age: Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Dysgeusia

Polyethylene Glycol

Pharmaceutical Product 3350

Powder For Oral

Complaint

Solution PS Kremers Urban ORAL 17GM MIXED IN

WATER, DRINK

ORALLYTWICE A

DAY

Date:11/14/06ISR Number: 5151513-9Report Type:Direct Company Report

#CTU 289305 Age: Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Dysgeusia

Polyethylene Glycol

Nausea 3350

Pwdr 527gm PS Teva 17GM MIXED IN

Pharmaceutical Product

WATER, JUICE

Complaint

& DRINK ONCE

OR TWICE

DAILY

17-Mar-2008 02:37 PM

Page: 13

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:11/14/06ISR Number: 5151514-0Report Type:Direct Company Report

#CTU 289306 Age:47 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Drug Ineffective

Polyethylene Glycol

Pharmaceutical Product 3350

PS Teva MIX 17 GRAMS

Complaint

(1 CAPFUL) IN

WATER AND

DRINK DAILY

(DURATION:

Date:11/27/06ISR Number: 5164410-XReport Type:Direct Company Report

#CTU 290019 Age: Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Vomiting

Polyethylene Glycol

3350

Nf Powder For

Oral

Solution PS Par ORAL 1 CAPFUL

TWICE A DAY

VIA NG TUB

Polyethylene Glycol

3350

Nf Powder For

Oral

Solution SS ORAL 1 CAPFUL ONCE

A DAY ORAL

Date:11/29/06ISR Number: 5163807-1Report Type:Direct Company Report

#CTU 290378 Age: Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Oedema Peripheral

Polyethylene Glycol

Rash Pruritic

3350, Nf Braintree

Skin Discolouration

Laboratories PS Braintree

Laboratories ORAL 17GR

DISSOLVED IN

8 OZ LIQUID

TWICE DAILY

PO

Date:11/30/06ISR Number: 5161741-4Report Type:Expedited (15-DaCompany Report

#JP-GLAXOSMITHKLINE-B0446482A Age:1 YR Gender:Female

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Bacterial Infection

Sawacillin PS Glaxosmithkline ORAL

2 DAY

Initial or Prolonged Convulsion

Dormicum SS UNKNOWN 1.2MGH per

Disseminated

day 6 DAY

Intravascular Coagulation

Froben SS ORAL 50MG per day

32 DAY

Drug Hypersensitivity

Glovenin SS Glaxosmithkline UNKNOWN 2GK per day

Epidermolysis

Flumarin SS UNKNOWN 100MGK per

Excoriation

day

Hyperthermia

Horizon SS Glaxosmithkline INTRAVENOUS

1 DAY

Ill-Defined Disorder

Flomox SS UNKNOWN

Kawasaki'S Disease

Polyethylene Glycol

Pyrexia

Treated Human Normal

Rash

Immunoglobulin SS Glaxosmithkline UNKNOWN

Acetaminophen C Glaxosmithkline RECTAL 100MG As

required 20 DAY

Gaster C INTRAVENOUS

6 DAY

Venilon C Glaxosmithkline INTRAVENOUS 2GK per day

2 DAY

Ulinastatin C UNKNOWN 50000UNIT Six

17-Mar-2008 02:37 PM

Page: 14

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

times per day 8 DAY

Date:12/01/06ISR Number: 5167673-XReport Type:Direct Company Report

#CTU 290540 Age:60 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Anal Discomfort

Polyethylene Glycol

Burning Sensation

(Peg) Anabolic Inc PS Anabolic Inc ORAL 17 GRAMS

Dry Mouth

DAILY ORALLY

Dry Throat

Erythema

Gastrointestinal Disorder

Oedema Peripheral

Throat Irritation

Date:12/01/06ISR Number: 5228942-8Report Type:Periodic Company Report

#147305USA Age: Gender:

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Dyspnoea Health

Polyethylene Glycol

Pharyngeal Oedema Professional

Powder For Oral

Other

Solution (Macrogol) PS ORAL ORAL

Date:12/07/06ISR Number: 5173173-3Report Type:Direct Company Report

#CTU 291068 Age:60 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Anal Discomfort

Polyethylene Glycol

Burning Sensation

(Peg) Anabolic Inc PS Anabolic Inc ORAL 17 GRAMS

Dry Mouth

DAILY ORALLY

Dry Throat

Erythema

Gastrointestinal Disorder

Oedema Peripheral

Throat Irritation

Date:12/08/06ISR Number: 5168235-0Report Type:Expedited (15-DaCompany Report

#JP-GLAXOSMITHKLINE-B0446482A Age:1 YR Gender:Female

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Bacterial Infection

Sawacillin PS Glaxosmithkline ORAL

2 DAY

Initial or Prolonged Convulsion

Dormicum SS UNKNOWN

6 DAY

Disseminated

Froben SS ORAL 50MG per day

32 DAY

Intravascular Coagulation

Glovenin SS Glaxosmithkline UNKNOWN

Drug Hypersensitivity

Flumarin SS UNKNOWN 100MGK per

Epidermolysis

day

Excoriation

Horizon SS Glaxosmithkline INTRAVENOUS

1 DAY

Hyperthermia

Flomox SS UNKNOWN

Ill-Defined Disorder

Polyethylene Glycol

Pyrexia

Treated Human Normal

Rash

Immunoglobulin SS Glaxosmithkline UNKNOWN

epam SS Glaxosmithkline

Acetaminophen C Glaxosmithkline RECTAL 100MG As

required 20 DAY

Gaster C INTRAVENOUS

6 DAY

Venilon C Glaxosmithkline INTRAVENOUS

2 DAY

Ulinastatin C UNKNOWN

8 DAY

Prednisolone C Glaxosmithkline 6MG per day

17-Mar-2008 02:37 PM

Page: 15

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:12/11/06ISR Number: 5175706-XReport Type:Direct Company Report

#CTU 291198 Age: Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Pharmaceutical Product

Polyethylene Glycol

Complaint 100%

Powder PS Teva

Date:12/15/06ISR Number: 5188841-7Report Type:Expedited (15-DaCompany Report

#NXG PC-0001 Age:60 YR Gender:Female

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Abdominal Discomfort Distributor

Polyethylene Glycol

Dry Mouth

(Peg) Anabolic

Dry Throat

Laboratories, Inc PS Anabolic

Oedema Peripheral

Laboratories, Inc ORAL 17 GM IN 8 OZ

Throat Irritation

WATER/DAY

ORAL (047)

Chemotherapeutic

Agents C

Date:01/03/07ISR Number: 5197149-5Report Type:Expedited (15-DaCompany Report

#JP-GLAXOSMITHKLINE-B0446482A Age:1 YR Gender:Female

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Bacterial Infection

Sawacillin PS Glaxosmithkline ORAL

14 DAY

Initial or Prolonged Convulsion

Dormicum SS UNKNOWN

6 DAY

Disseminated

Froben SS ORAL 50MG per day

32 DAY

Intravascular Coagulation

Glovenin SS Glaxosmithkline UNKNOWN

Drug Hypersensitivity

Flumarin SS UNKNOWN 100MGK per

Epidermolysis

day

Excoriation

Horizon SS Glaxosmithkline INTRAVENOUS

1 DAY

Hyperthermia

Flomox SS UNKNOWN

Ill-Defined Disorder

Polyethylene Glycol

Pyrexia

Treated Human Normal

Rash

Immunoglobulin SS Glaxosmithkline UNKNOWN

epam SS Glaxosmithkline

Acetaminophen C Glaxosmithkline RECTAL 100MG As

required 20 DAY

Gaster C INTRAVENOUS

6 DAY

Venilon C Glaxosmithkline INTRAVENOUS

2 DAY

Ulinastatin C UNKNOWN

8 DAY

Prednisolone C Glaxosmithkline 6MG per day

Date:01/08/07ISR Number: 5201002-8Report Type:Expedited (15-DaCompany Report

#JP-GLAXOSMITHKLINE-B0446482A Age:1 YR Gender:Female

I/FU:F

Outcome PT

Hospitalization - Alanine Aminotransferase

Initial or Prolonged Increased

Aspartate

Aminotransferase

Increased

Bacterial Infection

Blood Alkaline

Phosphatase Increased

Convulsion

Disseminated

Intravascular Coagulation

Drug Hypersensitivity

17-Mar-2008 02:37 PM

Page: 16

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Epidermolysis

Excoriation

Hepatic Function Abnormal Report Source

Product Role Manufacturer Route Dose

Duration

Hyperthermia

Sawacillin PS Glaxosmithkline ORAL

2 DAY

Ill-Defined Disorder

Dormicum SS INTRAVENOUS 1.2MGH per

Lymphocyte Stimulation

day 6 DAY

Test Positive

Froben SS ORAL 50MG per day

32 DAY

Pyrexia

Glovenin SS Glaxosmithkline UNKNOWN 2GK per day

26 DAY

Rash

Flumarin SS INTRAVENOUS 100MGK per

Vitamin K Deficiency

day

Horizon SS Glaxosmithkline INTRAVENOUS

1 DAY

Flomox SS UNKNOWN

Polyethylene Glycol

Treated Human Normal

Immunoglobulin SS Glaxosmithkline UNKNOWN

epam SS Glaxosmithkline

Acetaminophen C Glaxosmithkline RECTAL 100MG As

required 20 DAY

Gaster C INTRAVENOUS

6 DAY

Venilon C Glaxosmithkline INTRAVENOUS

2 DAY

Ulinastatin C UNKNOWN

8 DAY

Prednisolone C Glaxosmithkline 6MG per day

Date:01/29/07ISR Number: 5222817-6Report Type:Expedited (15-DaCompany Report

#JP-GLAXOSMITHKLINE-B0446482A Age:1 YR Gender:Female

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Bacterial Infection

Sawacillin PS Glaxosmithkline ORAL

2 DAY

Initial or Prolonged Convulsion

Dormicum SS INTRAVENOUS 1.2MGH per

Disseminated

day 6 DAY

Intravascular Coagulation

Froben SS ORAL 50MG per day

32 DAY

Drug Hypersensitivity

Glovenin SS Glaxosmithkline UNKNOWN 2GK per day

26 DAY

Epidermolysis

Flumarin SS INTRAVENOUS 100MGK per

Excoriation

day

Hepatic Function Abnormal

Horizon SS Glaxosmithkline INTRAVENOUS

1 DAY

Hyperthermia

Flomox SS UNKNOWN

Ill-Defined Disorder

Polyethylene Glycol

Pyrexia

Treated Human Normal

Rash

Immunoglobulin SS Glaxosmithkline UNKNOWN

Vitamin K Deficiency

epam SS Glaxosmithkline

Acetaminophen C Glaxosmithkline RECTAL 100MG As

required 20 DAY

Gaster C INTRAVENOUS

6 DAY

Venilon C Glaxosmithkline INTRAVENOUS

2 DAY

Ulinastatin C UNKNOWN

8 DAY

Prednisolone C Glaxosmithkline 6MG per day

Date:02/07/07ISR Number: 5235341-1Report Type:Direct Company Report

#CTU 295379 Age:72 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Body Temperature

Polyethlene Glycol

Increased 255

Gms 3350pf Per

Chills

Pharmaceutical

Drug Hypersensitivity

Ndc49884-0146- PS ORAL 255 GRAMS

Rash Erythematous

SINGLE DOSE

Urticaria

PO

17-Mar-2008 02:37 PM

Page: 17

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:02/23/07ISR Number: 5247632-9Report Type:Direct Company Report

#CTU 296657 Age:54 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Dysgeusia

Polyethylene Glycol

Pharmaceutical Product 3350

225 Grams Of

Complaint 3350

Nf Powder Par

Pharmaceutical Product

Pharmaceutical PS Par Pharmaceutical ORAL 17 GRAMS

Counterfeit

DAILY PO

Date:02/28/07ISR Number: 5253952-4Report Type:Direct Company Report

#CTU 296939 Age:7 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Gastrointestinal Pain

Polyethylene Glucol

Muscle Spasms

(Peg) 3350 PS

Pharmaceutical Product

Complaint

Date:03/05/07ISR Number: 5256923-7Report Type:Direct Company Report

#CTU 297288 Age:97 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Blood Pressure Increased

Polyethylene Glycol

Dizziness 3350

Par

Dysphonia

Pharmaceuticals PS Par Pharmaceuticals 17 GM IN 80Z

Ear Discomfort

WATER ONCE A

Feeling Hot

DAY UNK

Headache

Date:03/12/07ISR Number: 5265939-6Report Type:Direct Company Report

#CTU 297771 Age:3 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Abnormal Faeces

Polyethylene Glycol

Arthralgia 3350

3350 Nf Powder

Crystal Urine Present

Affordable

Cystitis

Pharmaceuticals PS Affordable

Developmental Delay

Pharmaceuticals ORAL 17 GRAMS 1 X

Dysuria

PER DAY PO 15 MON

Escherichia Infection

Growth Retardation

Penile Discharge

Pharmaceutical Product

Complaint

Purulent Discharge

Rectal Prolapse

Speech Disorder

Developmental

Date:03/20/07ISR Number: 5274619-2Report Type:Expedited (15-DaCompany Report

#PAR_1415_2007 Age:10 YR Gender:Female

I/FU:I

Outcome

Other

Required

Intervention to

Prevent Permanent

17-Mar-2008 02:37 PM

Page: 18

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Impairment/Damage

PT Report Source

Product Role Manufacturer Route Dose

Duration

Blood Pressure Increased Consumer

Polyethylene Glycol

Diarrhoea

3350, Nf Powder For

Dyspnoea Oral

Solution PS ORAL 17 G ONCE PO

Heart Rate Increased

Hypersensitivity

Pruritus

Urticaria

Date:03/22/07ISR Number: 5272761-3Report Type:Expedited (15-DaCompany Report

#JP-GLAXOSMITHKLINE-B0446482A Age:1 YR Gender:Female

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Bacterial Infection

Sawacillin PS Glaxosmithkline ORAL

2 DAY

Initial or Prolonged Convulsion

Dormicum SS INTRAVENOUS 1.2MGH per

Disseminated

day 6 DAY

Intravascular Coagulation

Froben SS ORAL 50MG per day

32 DAY

Drug Hypersensitivity

Glovenin SS Glaxosmithkline UNKNOWN 2GK per day

26 DAY

Epidermolysis

Flumarin SS INTRAVENOUS 100MGK per

Excoriation

day

Hepatic Function Abnormal

Horizon SS Glaxosmithkline INTRAVENOUS

1 DAY

Hyperthermia

Flomox SS UNKNOWN

Ill-Defined Disorder

Polyethylene Glycol

Pyrexia

Treated Human Normal

Rash

Immunoglobulin SS Glaxosmithkline UNKNOWN

Vitamin K Deficiency

epam SS Glaxosmithkline

Acetaminophen C Glaxosmithkline RECTAL 100MG As

required 20 DAY

Gaster C INTRAVENOUS

6 DAY

Venilon C Glaxosmithkline INTRAVENOUS

2 DAY

Ulinastatin C UNKNOWN

8 DAY

Prednisolone C Glaxosmithkline 6MG per day

Date:04/05/07ISR Number: 5288410-4Report Type:Expedited (15-DaCompany Report

#JP-MERCK-0704USA00117 Age: Gender:

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Death Drug Interaction

Indocin

(Indomethacin) PS Merck & Co., Inc RECTAL

Polyethylene Glycol SS RECTAL

Date:04/23/07ISR Number: 5304589-XReport Type:Expedited (15-DaCompany Report

#JP-GLAXOSMITHKLINE-B0446482A Age:1 YR Gender:Female

I/FU:F

Outcome PT

Hospitalization - Bacterial Infection

Initial or Prolonged Convulsion

Disseminated

Intravascular Coagulation

Drug Rash With

Eosinophilia And Systemic

Symptoms

Epidermolysis

Excoriation

Hepatic Function Abnormal

Hyperthermia

17-Mar-2008 02:37 PM

Page: 19

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Ill-Defined Disorder

Pyrexia

Rash Report Source

Product Role Manufacturer Route Dose

Duration

Vitamin K Deficiency

Sawacillin PS Glaxosmithkline ORAL

2 DAY

Dormicum SS INTRAVENOUS 1.2MGH per

day 6 DAY

Froben SS ORAL 50MG per day

32 DAY

Glovenin SS Glaxosmithkline UNKNOWN 2GK per day

26 DAY

Flumarin SS INTRAVENOUS 100MGK per

day

Horizon SS Glaxosmithkline INTRAVENOUS

1 DAY

Flomox SS UNKNOWN

Polyethylene Glycol

Treated Human Normal

Immunoglobulin SS Glaxosmithkline UNKNOWN

epam SS Glaxosmithkline

Cefzon SS UNKNOWN

Acetaminophen C Glaxosmithkline RECTAL 100MG As

required 20 DAY

Gaster C INTRAVENOUS

6 DAY

Venilon C Glaxosmithkline INTRAVENOUS

2 DAY

Ulinastatin C UNKNOWN

8 DAY

Prednisolone C Glaxosmithkline 6MG per day

Date:05/03/07ISR Number: 5315804-0Report Type:Expedited (15-DaCompany Report

#JP-GLAXOSMITHKLINE-B0446482A Age:1 YR Gender:Female

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Bacterial Infection

Sawacillin PS Glaxosmithkline ORAL

2 DAY

Initial or Prolonged Convulsion

Dormicum SS INTRAVENOUS 1.2MGH per

Disseminated

day 6 DAY

Intravascular Coagulation

Froben SS ORAL 50MG per day

32 DAY

Drug Rash With

Glovenin SS Glaxosmithkline UNKNOWN 2GK per day

26 DAY

Eosinophilia And Systemic

Flumarin SS INTRAVENOUS 100MGK per

Symptoms

day

Epidermolysis

Horizon SS Glaxosmithkline INTRAVENOUS

1 DAY

Excoriation

Flomox SS UNKNOWN

Hepatic Function Abnormal

Polyethylene Glycol

Hyperthermia

Treated Human Normal

Ill-Defined Disorder

Immunoglobulin SS Glaxosmithkline UNKNOWN

Pyrexia

epam SS Glaxosmithkline

Rash

Cefzon SS ORAL 40MG Three

Vitamin K Deficiency

times per day 3 DAY

Acetaminophen C Glaxosmithkline RECTAL 100MG As

required 20 DAY

Gaster C INTRAVENOUS

6 DAY

Venilon C Glaxosmithkline INTRAVENOUS

2 DAY

Ulinastatin C UNKNOWN

8 DAY

Prednisolone C Glaxosmithkline 6MG per day

Date:05/07/07ISR Number: 5321179-3Report Type:Direct Company Report

#CTU 302610 Age:33 YR Gender:Female

I/FU:I

Outcome PT

Hospitalization - Blindness

Initial or Prolonged Chest Pain

Drug Exposure During

Pregnancy

Pruritus

17-Mar-2008 02:37 PM

Page: 20

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Swelling Face

Vomiting

Report Source

Product Role Manufacturer Route Dose

Duration

Polyethylene Glycol

Powder- Affordable

Pharm PS Affordable Pharm ORAL 1 PACK IN

WATER ONCE

DAILY ORALLY

Date:05/10/07ISR Number: 5321503-1Report Type:Expedited (15-DaCompany Report

#JP-MERCK-0704USA00117 Age: Gender:

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Death Drug Interaction

Indocin

(Indomethacin) PS Merck & Co., Inc RECTAL

Polyethylene Glycol SS RECTAL

Date:05/11/07ISR Number: 5326935-3Report Type:Expedited (15-DaCompany Report

#070055 Age:33 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Anaphylactic Reaction Consumer

Polyethylene Glycol

Burning Sensation

3350, Nf Powder For

Fatigue

Solution PS ORAL 17G/8OZ,

Headache

WEEKLY, PO

Vomiting

Advair C

Flonase C

Date:06/11/07ISR Number: 5355759-6Report Type:Direct Company Report

#CTU 305324 Age:5 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Aggression

Polyethylene Glycol

Homicidal Ideation 3350

PS ORAL 1/2 CAPFUL 1

PO

Date:07/13/07ISR Number: 5389077-7Report Type:Expedited (15-DaCompany Report

#16926 Age:17 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Life-Threatening Ascites Literature

Vincristine PS

Hospitalization - Bacterial Infection Health

Doxorubicin SS

Initial or Prolonged Dialysis Professional

Dexamethasone SS

Diverticular Perforation

Polyethylene

Escherichia Infection

Glycol-Asparaginase SS

Ileus

Opiates SS

Mucosal Inflammation

Ranitidine C

Neutropenia

Maxipime. Mfr:

Pneumoperitoneum

Bristol-Myers Squibb C Bristol-Myers Squibb

Sepsis

Tobramycin C

Vitello-Intestinal Duct

Remnant

17-Mar-2008 02:37 PM

Page: 21

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:08/02/07ISR Number: 5406003-2Report Type:Direct Company Report

#CTU 309358 Age:56 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Pharmaceutical Product

Polyethylene Glycol

Complaint

255gm Breckenridge PS Breckenridge ORAL ONE TBS DAILY

PO

Date:08/10/07ISR Number: 5411529-1Report Type:Expedited (15-DaCompany Report

#US-ROXANE LABORATORIES, INC-2007-BP-18596RO Age:17 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Abdominal Pain

Dexamethasone PS Roxane Laboratories,

Initial or Prolonged Ascites

Inc.

Constipation

Ranitidine SS B.I.

Diverticular Perforation

Pharmaceuticals,Inc.

Drug Ineffective For

/Ridgefield

Unapproved Indication

Polyethylene

Febrile Neutropenia

Glycol-Asparaginase SS

Gastritis

Vincristine SS

Haematemesis

Doxorubicin SS

Ileus

Opiates SS

Mucosal Inflammation

Ranitidine C

Pneumoperitoneum

Opiates C

Sepsis

Date:08/21/07ISR Number: 5422062-5Report Type:Direct Company Report

#CTU 310945 Age:70 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Life-Threatening Atrial Fibrillation

Hydrochlorothiazide PS ORAL 25MG AM PO

Hospitalization - Electrolyte Imbalance

Polyethylene Glycol

Initial or Prolonged Palpitations 3350

SS ORAL 4 LITERS ONCE

Required

PO

Intervention to

Prevent Permanent

Impairment/Damage

Date:09/27/07ISR Number: 5474814-3Report Type:Direct Company Report

#CTU 314025 Age:49 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Disability Blood Potassium Increased

Polyethylene Glycol

3350

PS ORAL 3,000 ML ONE

TIME PO

Date:10/17/07ISR Number: 5489714-2Report Type:Direct Company Report

#CTU 315566 Age:33 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Abdominal Pain Upper

Polyethylene Glycol

Dysgeusia 3350

Powder

Pharmaceutical Product

Breckenridge

Complaint

Pharmaceutical, PS Breckenridge

Therapeutic Response

Pharmaceutical ORAL 17 GRAMS ONCE

Unexpected With Drug

PO

Substitution

17-Mar-2008 02:37 PM

Page: 22

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:10/22/07ISR Number: 5494469-1Report Type:Direct Company Report

#CTU 315964 Age:40 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Dysgeusia

Polyethylene Glycol

Pharmaceutical Product 3350

Nf Breckenridge

Complaint

Pharmaceutical, Inc PS Breckenridge

Pharmaceutical, Inc ORAL 17 GM

DISOLVED IN

WATER ONCE A

DAY PO 3 YR

Date:11/02/07ISR Number: 5505264-9Report Type:Expedited (15-DaCompany Report

#US-RANBAXY-2007RR-10918 Age: Gender:

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Mallory-Weiss Syndrome

Bisacodyl PS Ranbaxy

Initial or Prolonged

Pharmaceuticals,

Inc.

Magnesium Citrate SS

Polyethylene Glycol SS

Date:11/02/07ISR Number: 5505265-0Report Type:Expedited (15-DaCompany Report

#US-RANBAXY-2007RR-10917 Age: Gender:

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Colitis Ischaemic

Bisacodyl PS Ranbaxy

Initial or Prolonged

Pharmaceuticals,

Inc.

Polyethylene Glycol SS

Date:11/02/07ISR Number: 5505268-6Report Type:Expedited (15-DaCompany Report

#US-RANBAXY-2007RR-10915 Age: Gender:

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Colitis Ischaemic

Bisacodyl PS Ranbaxy

Pharmaceuticals,

Inc.

Polyethylene Glycol SS

Date:11/07/07ISR Number: 5510838-5Report Type:Expedited (15-DaCompany Report

#163486USA Age:56 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Colitis Ischaemic Literature

Polyethylene Glycol PS ORAL ORAL

Health

Bisacodyl SS 4 TABLETS ONE

Professional

DAY

Date:11/07/07ISR Number: 5510840-3Report Type:Expedited (15-DaCompany Report

#163487USA Age:78 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Colitis Ischaemic Literature

Polyethylene Glycol PS ORAL ORAL

Initial or Prolonged Large Intestine Health

Bisacodyl SS 4 TABLETS ONE

Perforation Professional

DAY

17-Mar-2008 02:37 PM

Page: 23

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Date:11/08/07ISR Number: 5512757-7Report Type:Expedited (15-DaCompany Report

#163468USA Age:72 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Mallory-Weiss Syndrome Literature

Polyethylene Glycol PS ORAL ORAL

Mucosal Discolouration Health

Bisacodyl SS ORAL ORAL

Pallor Professional

Magnesium Citrate SS ORAL ORAL

Vomiting

Date:11/19/07ISR Number: 5523039-1Report Type:Direct Company Report

#CTU 318103 Age:60 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Angioedema

Polyethylene Glycol

Initial or Prolonged 3350

PS ORAL 1 GAL PO

Required

Intervention to

Prevent Permanent

Impairment/Damage

Date:11/30/07ISR Number: 5530876-6Report Type:Expedited (15-DaCompany Report

#US-RANBAXY-2007RR-10915 Age: Gender:

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Colitis Ischaemic

Bisacodyl PS Ranbaxy

Pharmaceuticals,

Inc.

Polyethylene Glycol SS

Date:12/14/07ISR Number: 5558026-0Report Type:Expedited (15-DaCompany Report

#US-RANBAXY-2007RR-10918 Age: Gender:

I/FU:F

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Hospitalization - Mallory-Weiss Syndrome

Bisacodyl PS Ranbaxy

Initial or Prolonged

Pharmaceuticals,

Inc.

Magnesium Citrate SS

Polyethylene Glycol SS

Date:12/26/07ISR Number: 5574755-7Report Type:Direct Company Report

#CTU 320981 Age:87 YR Gender:Female

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Diarrhoea

Polyethylene Glycol

Dysgeusia

Breckenridge

Muscle Spasms

Pharmaceutical, Inc PS Breckenridge

Therapeutic Response

Pharmaceutical, Inc 1 SCOOP DAILY

Unexpected With Drug

Substitution

Date:12/27/07ISR Number: 5574863-0Report Type:Expedited (15-DaCompany Report

#NL-BRISTOL-MYERS SQUIBB COMPANY-14024657 Age:70 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Small Intestinal

Amphotericin B PS Apothecon TOPICAL

Obstruction

Polymyxin B SS TOPICAL

Tobramycin SS TOPICAL

17-Mar-2008 02:37 PM

Page: 24

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Polyethylene Glycol SS

Date:12/27/07ISR Number: 5577686-1Report Type:Expedited (15-DaCompany Report

#002#8#2007-00386 Age:3 YR Gender:Male

I/FU:I

Outcome PT Report Source

Product Role Manufacturer Route Dose

Duration

Other Abdominal Distension Literature

Peg-3350- & -Electroly

Accidental Exposure

tes-For-Oral-Solutio

Acute Respiratory n

(Polyethylene

Distress Syndrome

Glycol 3350) PS 150ML, 1 IN 1

Areflexia

H,

Bradycardia

NASOGASTRIC

Grand Mal Convulsion

Bupropion SS ORAL 2.4 MG, 1,

Hypotension

ORAL

Incorrect Dose

Administered

No Therapeutic Response

Off Label Use

Overdose

Pneumonia Aspiration

Post Procedural

Complication

Pulmonary Oedema

Pulse Absent

Sinus Tachycardia

Somnolence

Vomiting

17-Mar-2008 02:37 PM

Page: 25

FDA - Adverse

Event Reporting System (AERS)

Freedom Of

Information (FOI) Report

Summary report for FOI selections:

Selection by inexact search of active ingredient:

NOINGRED%

Selection by inexact search of Tradename/Verbatim:

POLYETHYLENE_G%

Total number of reports: 100

From: 01-NOV-1997 To: Present

17-Mar-2008 02:37 PM

Page: 26

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