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Depakene (Valproic Acid) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (66)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Depakene (Valproic Acid) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 66   Next >>

Possible Depakene side effects in

Reported by a physician from Japan on 2012-08-22

Patient:

Reactions: Multi-Organ Failure, Diarrhoea, Acute Respiratory Distress Syndrome, Hepatorenal Failure, Drug Rash With Eosinophilia and Systemic Symptoms, Convulsion, Disease Progression

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2006-11-11
    End date: 2009-09-07

Phenytoin Sodium CAP
    Indication: Status Epilepticus
    Start date: 2009-06-25
    End date: 2009-09-07

Tegretol
    Administration route: Oral
    Indication: Status Epilepticus
    Start date: 2009-06-25
    End date: 2009-09-07

Temodal
    Dosage: 150 mg/m2, qd
    Administration route: Oral
    Start date: 2010-06-11
    End date: 2010-10-05

Temodal
    Administration route: Oral
    Start date: 2008-02-21
    End date: 2008-02-25

Temodal
    Dosage: 150 mg/m2, qd
    Administration route: Oral
    Start date: 2009-09-28
    End date: 2010-05-04

Temodal
    Administration route: Oral
    Start date: 2007-11-29
    End date: 2007-12-03

Temodal
    Administration route: Oral
    Start date: 2008-04-17
    End date: 2008-04-21

Temodal
    Administration route: Oral
    Start date: 2008-10-02
    End date: 2008-10-06

Temodal
    Administration route: Oral
    Start date: 2008-10-30
    End date: 2008-11-03

Temodal
    Administration route: Oral
    Start date: 2010-02-08
    End date: 2010-02-12

Temodal
    Administration route: Oral
    Start date: 2010-03-08
    End date: 2010-03-12

Temodal
    Administration route: Oral
    Start date: 2010-06-11
    End date: 2010-06-15

Temodal
    Dosage: 150 mg/m2, qd
    Administration route: Oral
    Start date: 2007-01-25
    End date: 2009-05-18

Temodal
    Administration route: Oral
    Start date: 2007-03-22
    End date: 2007-03-26

Temodal
    Administration route: Oral
    Start date: 2007-06-14
    End date: 2007-06-18

Temodal
    Administration route: Oral
    Start date: 2007-08-09
    End date: 2007-08-13

Temodal
    Administration route: Oral
    Start date: 2007-10-04
    End date: 2007-10-08

Temodal
    Administration route: Oral
    Start date: 2009-12-14
    End date: 2009-12-18

Temodal
    Administration route: Oral
    Start date: 2008-05-15
    End date: 2008-05-19

Temodal
    Administration route: Oral
    Start date: 2009-10-26
    End date: 2009-10-30

Temodal
    Dosage: 75 mg/m2, qd
    Administration route: Oral
    Indication: Glioblastoma Multiforme
    Start date: 2006-11-28
    End date: 2006-12-26

Temodal
    Administration route: Oral
    Start date: 2007-02-22
    End date: 2007-02-26

Temodal
    Administration route: Oral
    Start date: 2007-11-01
    End date: 2007-11-05

Temodal
    Administration route: Oral
    Start date: 2008-03-20
    End date: 2008-03-24

Temodal
    Administration route: Oral
    Start date: 2008-07-10
    End date: 2008-07-14

Temodal
    Administration route: Oral
    Start date: 2009-01-22
    End date: 2009-01-26

Temodal
    Administration route: Oral
    Start date: 2009-04-16
    End date: 2009-04-20

Temodal
    Administration route: Oral
    Start date: 2010-01-11
    End date: 2010-01-15

Temodal
    Administration route: Oral
    Start date: 2010-07-09
    End date: 2010-07-13

Temodal
    Administration route: Oral
    Start date: 2010-09-03
    End date: 2010-09-07

Temodal
    Administration route: Oral
    Start date: 2007-01-25
    End date: 2007-01-29

Temodal
    Administration route: Oral
    Start date: 2007-09-06
    End date: 2007-09-10

Temodal
    Administration route: Oral
    Start date: 2007-12-27
    End date: 2007-12-31

Temodal
    Administration route: Oral
    Start date: 2008-01-24
    End date: 2008-01-28

Temodal
    Administration route: Oral
    Start date: 2008-08-07
    End date: 2008-08-11

Temodal
    Administration route: Oral
    Start date: 2009-03-19
    End date: 2009-03-23

Temodal
    Administration route: Oral
    Start date: 2010-05-03
    End date: 2010-05-04

Temodal
    Administration route: Oral
    Start date: 2007-04-19
    End date: 2007-04-23

Temodal
    Administration route: Oral
    Start date: 2007-05-17
    End date: 2007-05-21

Temodal
    Administration route: Oral
    Start date: 2007-07-12
    End date: 2007-07-16

Temodal
    Administration route: Oral
    Start date: 2008-09-04
    End date: 2008-09-08

Temodal
    Administration route: Oral
    Start date: 2008-11-28
    End date: 2008-12-02

Temodal
    Administration route: Oral
    Start date: 2008-12-25
    End date: 2008-12-29

Temodal
    Administration route: Oral
    Start date: 2009-02-19
    End date: 2009-02-23

Temodal
    Administration route: Oral
    Start date: 2009-05-14
    End date: 2009-05-18

Temodal
    Administration route: Oral
    Start date: 2009-09-28
    End date: 2009-10-02

Temodal
    Administration route: Oral
    Start date: 2010-04-05
    End date: 2010-04-09

Temodal
    Administration route: Oral
    Start date: 2008-06-12
    End date: 2008-06-16

Temodal
    Administration route: Oral
    Start date: 2010-08-06
    End date: 2010-08-10

Temodal
    Administration route: Oral
    Start date: 2010-10-01
    End date: 2010-10-05

Other drugs received by patient: Depakene; Phenobarbital TAB; Betamethasone Sodium Phosphate; Kytril; Zonisamide; Diprivan; Isozol; Topiramate; Bacillus Subtilis (+) Lactobacillus Acidophilus (+) Streptococcus Faec



Possible Depakene side effects in male

Reported by a physician from Italy on 2012-08-13

Patient: male

Reactions: Hyperthermia, Suicide Attempt

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-06-01
    End date: 2011-10-01

Escitalopram
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-06-01
    End date: 2011-10-01

Seroquel
    Administration route: Oral
    Indication: Major Depression
    Start date: 2011-06-01
    End date: 2011-10-01



Possible Depakene side effects in male

Reported by a physician from Japan on 2012-08-07

Patient: male

Reactions: Pyrexia, Eczema, Lymphocyte Stimulation Test Positive, Oral Mucosa Erosion, Stevens-Johnson Syndrome, LIP Erosion

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Dosage: 500mg per day
    Administration route: Oral
    Indication: Mood Swings
    Start date: 2012-01-23
    End date: 2012-06-22

Lamictal
    Dosage: 12.5mg per day
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-05-28
    End date: 2012-06-01

Lamictal
    Dosage: 25mg per day
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-22

Topiramate
    Dosage: 350mg per day
    Administration route: Oral
    Indication: Post-Traumatic Stress Disorder
    Start date: 2012-01-23
    End date: 2012-06-22



Possible Depakene side effects in 67 year old female

Reported by a physician from Japan on 2012-07-31

Patient: 67 year old female, weighing 42.0 kg (92.4 pounds)

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 0.4 mg, as needed
    Indication: Antipyresis
    Start date: 2012-01-01
    End date: 2012-05-07

Acetaminophen
    Indication: Analgesic Therapy

Albumin Tannate
    Dosage: 1 g, as needed
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-27
    End date: 2012-05-07

Alfarol
    Dosage: 0.5 ug (1ml) a day
    Indication: Osteoporosis
    Start date: 2012-04-19
    End date: 2012-05-07

Ambisome
    Dosage: 100 mg a day
    Indication: Infection
    Start date: 2012-04-25
    End date: 2012-05-04

Cefazolin Sodium
    Dosage: 1 g, 3x/day
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-19
    End date: 2012-05-07

Clindamycin HCL
    Indication: Muscle Abscess

Clindamycin HCL
    Dosage: 1200 mg, 2x/day
    Indication: Meningitis
    Start date: 2012-04-11
    End date: 2012-05-06

Depakene
    Dosage: 400 mg (8ml) daily
    Indication: Convulsion
    Start date: 2012-04-13
    End date: 2012-05-07

Lansoprazole
    Dosage: 30 mg a day
    Indication: Gastric Ulcer
    Start date: 2012-03-21
    End date: 2012-05-07

Lendormin
    Dosage: 0.25 mg, as needed
    Indication: Insomnia
    Start date: 2012-04-21

Meropenem
    Dosage: 2 g, daily
    Start date: 2012-04-27
    End date: 2012-05-06

Meropenem
    Dosage: 1 g, daily
    Indication: Muscle Abscess
    Start date: 2012-04-11
    End date: 2012-04-20

Meropenem
    Dosage: 2mg, daily
    Indication: Meningitis
    Start date: 2012-01-17
    End date: 2012-02-16

Vancomycin
    Dosage: 0.5g/2days
    Indication: Muscle Abscess
    Start date: 2012-03-07
    End date: 2012-04-09

Vancomycin
    Dosage: 1 g/4days
    Indication: Meningitis
    Start date: 2012-02-07
    End date: 2012-02-15

Vancomycin
    Dosage: 0.5g/4days
    Start date: 2012-04-27
    End date: 2012-05-06

Other drugs received by patient: Ceftriaxone; Isoniazid; Ethambutol; Rifampicin; Prodif; Prednisolone; Ampicillin; Pyrazinamide



Possible Depakene side effects in female

Reported by a physician from China on 2012-07-30

Patient: female

Reactions: Hepatic Function Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in 67 year old female

Reported by a physician from Japan on 2012-07-26

Patient: 67 year old female, weighing 42.0 kg (92.4 pounds)

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Indication: Analgesic Therapy

Acetaminophen
    Dosage: 0.4 mg, as needed
    Indication: Antipyresis
    Start date: 2012-01-01
    End date: 2012-05-07

Albumin Tannate
    Dosage: 1 g, as needed
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-27
    End date: 2012-05-07

Alfarol
    Dosage: 0.5 ug (1ml) a day
    Indication: Osteoporosis
    Start date: 2012-04-19
    End date: 2012-05-07

Ambisome
    Dosage: 100 mg a day
    Indication: Infection
    Start date: 2012-04-25
    End date: 2012-05-04

Cefazolin Sodium
    Dosage: 1 g, 3x/day
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-19
    End date: 2012-05-07

Clindamycin HCL
    Dosage: 1200 g, 2x/day
    Indication: Meningitis
    Start date: 2012-04-11
    End date: 2012-05-06

Clindamycin HCL
    Indication: Muscle Abscess

Depakene
    Dosage: 400 mg (8ml) daily
    Indication: Convulsion
    Start date: 2012-04-13
    End date: 2012-05-07

Lansoprazole
    Dosage: 30 mg a day
    Indication: Gastric Ulcer
    Start date: 2012-03-21
    End date: 2012-05-07

Lendormin
    Dosage: 0.25 mg, as needed
    Indication: Insomnia
    Start date: 2012-04-21

Meropenem
    Dosage: 2 g, daily
    Start date: 2012-04-27
    End date: 2012-05-06

Meropenem
    Dosage: 1 g, daily
    Indication: Muscle Abscess
    Start date: 2012-04-11
    End date: 2012-04-20

Meropenem
    Dosage: 2mg, daily
    Indication: Meningitis
    Start date: 2012-01-17
    End date: 2012-02-16

Vancomycin
    Dosage: 0.5g/2days
    Indication: Muscle Abscess
    Start date: 2012-03-07
    End date: 2012-04-09

Vancomycin
    Dosage: 1 g/4days
    Indication: Meningitis
    Start date: 2012-02-07
    End date: 2012-02-15

Vancomycin
    Dosage: 0.5g/4days
    Start date: 2012-04-27
    End date: 2012-05-06

Other drugs received by patient: Prednisolone; Isoniazid; Rifampicin; Ethambutol; Prodif; Ceftriaxone; Ampicillin; Pyrazinamide



Possible Depakene side effects in 67 year old female

Reported by a physician from Japan on 2012-07-20

Patient: 67 year old female, weighing 42.0 kg (92.4 pounds)

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 0.4 mg, as needed
    Indication: Antipyresis
    Start date: 2012-01-01
    End date: 2012-05-07

Acetaminophen
    Indication: Analgesic Therapy

Albumin Tannate
    Dosage: 1 g, as needed
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-27
    End date: 2012-05-07

Alfarol
    Dosage: 0.5 ug (1ml) a day
    Indication: Osteoporosis
    Start date: 2012-04-19
    End date: 2012-05-07

Ambisome
    Dosage: 100 mg a day
    Indication: Infection
    Start date: 2012-04-25
    End date: 2012-05-04

Cefazolin Sodium
    Dosage: 1 g, 3x/day
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-19
    End date: 2012-05-07

Clindamycin HCL
    Indication: Muscle Abscess

Clindamycin HCL
    Dosage: 1200 g, 2x/day
    Indication: Meningitis
    Start date: 2012-04-11
    End date: 2012-05-06

Depakene
    Dosage: 400 mg (8ml) daily
    Indication: Convulsion
    Start date: 2012-04-13
    End date: 2012-05-07

Lansoprazole
    Dosage: 30 mg a day
    Indication: Gastric Ulcer
    Start date: 2012-03-21
    End date: 2012-05-07

Lendormin
    Dosage: 0.25 mg, as needed
    Indication: Insomnia
    Start date: 2012-04-21

Meropenem
    Dosage: 2 g, daily
    Start date: 2012-04-27
    End date: 2012-05-06

Meropenem
    Dosage: 0.5 g, daily
    Indication: Meningitis
    Start date: 2012-01-17
    End date: 2012-02-16

Meropenem
    Dosage: 1 g, daily
    Indication: Muscle Abscess
    Start date: 2012-04-11
    End date: 2012-04-20

Vancomycin
    Dosage: 0.25 mg, 2x/day, every other day
    Indication: Muscle Abscess
    Start date: 2012-03-07
    End date: 2012-04-09

Vancomycin
    Dosage: 0.25 g, 2x/week
    Start date: 2012-04-27
    End date: 2012-05-06

Vancomycin Hychloride
    Dosage: 0.25 g, 2x/week
    Indication: Meningitis
    Start date: 2012-02-07
    End date: 2012-02-15

Other drugs received by patient: Ampicillin; Rifampicin; Pyrazinamide; Ethambutol; Prednisolone; Isoniazid; Prodif; Ceftriaxone



Possible Depakene side effects in 61 year old male

Reported by a physician from Japan on 2012-07-18

Patient: 61 year old male

Reactions: Anaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Depakene
    Dosage: daily dose: 400 mg
    Administration route: Oral
    Indication: Partial Seizures With Secondary Generalisation
    End date: 2012-04-19

Keppra
    Administration route: Oral
    Indication: Partial Seizures With Secondary Generalisation
    Start date: 2012-03-19
    End date: 2012-03-25

Keppra
    Administration route: Oral
    Start date: 2012-03-11
    End date: 2012-03-18

Other drugs received by patient: Diapp; Lamictal; Phenobarbital TAB



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-18

Patient: male

Reactions: Hypotension, Hypoglycaemia, Bradykinesia, Sopor, Bradyphrenia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Apidra
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Depakene
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetine Hydrochloride
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Humalog
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Tramadol HCL
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Valium
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Other drugs received by patient: Ramipril



Possible Depakene side effects in 67 year old female

Reported by a physician from Japan on 2012-07-12

Patient: 67 year old female, weighing 42.0 kg (92.4 pounds)

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Indication: Analgesic Therapy

Acetaminophen
    Dosage: 0.4 mg, as needed
    Indication: Antipyresis
    Start date: 2012-01-01
    End date: 2012-05-07

Albumin Tannate
    Dosage: 1 g, as needed
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-27
    End date: 2012-05-07

Alfarol
    Dosage: 0.5 ug (1ml) a day
    Indication: Osteoporosis
    Start date: 2012-04-19
    End date: 2012-05-07

Ambisome
    Dosage: 100 mg a day
    Indication: Infection
    Start date: 2012-04-25
    End date: 2012-05-04

Cefazolin Sodium
    Dosage: 1 g, 3x/day
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-19
    End date: 2012-05-07

Clindamycin HCL
    Dosage: 1200 g, 2x/day
    Indication: Meningitis
    Start date: 2012-04-11
    End date: 2012-05-06

Clindamycin HCL
    Indication: Muscle Abscess

Depakene
    Dosage: 400 mg (8ml) daily
    Indication: Convulsion
    Start date: 2012-04-13
    End date: 2012-05-07

Lansoprazole
    Dosage: 30 mg a day
    Indication: Gastric Ulcer
    Start date: 2012-03-21
    End date: 2012-05-07

Lendormin
    Dosage: 0.25 mg, as needed
    Indication: Insomnia
    Start date: 2012-04-21

Meropenem
    Dosage: 0.5 g, daily
    Indication: Meningitis
    Start date: 2012-01-17
    End date: 2012-02-16

Meropenem
    Dosage: 2 g, daily
    Start date: 2012-04-27
    End date: 2012-05-06

Meropenem
    Dosage: 1 g, daily
    Indication: Muscle Abscess
    Start date: 2012-04-11
    End date: 2012-04-20

Vancomycin Hydrochloride
    Dosage: 0.25 mg, 2x/day, every other day
    Indication: Muscle Abscess
    Start date: 2012-03-07
    End date: 2012-04-09

Vancomycin Hydrochloride
    Dosage: 0.25 g, 2x/week
    Indication: Meningitis
    Start date: 2012-02-07
    End date: 2012-02-15

Vancomycin Hydrochloride
    Dosage: 0.25 g, 2x/week
    Start date: 2012-04-27
    End date: 2012-05-06

Other drugs received by patient: Rifampicin; Ethambutol; Pyrazinamide; Prodif; Prednisolone; Isoniazid; Ceftriaxone; Ampicillin



Possible Depakene side effects in male

Reported by a physician from France on 2012-07-10

Patient: male

Reactions: Pancreatitis Acute, Pneumonia, Systemic Inflammatory Response Syndrome, Circulatory Collapse, Respiratory Distress, Organ Failure

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral
    Indication: Cerebrovascular Accident

Depakene
    Administration route: Oral
    Indication: Epilepsy
    End date: 2012-02-28

Dipiperon
    Administration route: Oral

Diprivan
    Indication: Anaesthesia
    Start date: 2012-02-27
    End date: 2012-02-27

Lioresal
    Indication: Cerebrovascular Accident



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-09

Patient: male

Reactions: Hypokinesia, Intentional Overdose, Hypoglycaemia, Hypotension, Suicide Attempt, Sopor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Apidra
    Dosage: 100 iu/milliltre, 3 milliliters once
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-05-23
    End date: 2012-05-23

Apidra
    Indication: Suicide Attempt

Depakene
    Dosage: once
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetime Hydrochloride
    Indication: Suicide Attempt

Duloxetime Hydrochloride
    Dosage: once
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-23
    End date: 2012-05-23

Humalog
    Dosage: once
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Dosage: once
    Administration route: Oral
    Indication: Diabetic Neuropathy
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Indication: Suicide Attempt

Optiset
    Dosage: 3 times a day, once
    Indication: Device Therapy
    Start date: 2012-05-23
    End date: 2012-05-23

Tramadol HCL
    Dosage: once
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Valium
    Dosage: once
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Other drugs received by patient: Ramipril; Lantus



Possible Depakene side effects in 40 year old male

Reported by a physician from Italy on 2012-07-06

Patient: 40 year old male

Reactions: Hypokinesia, Intentional Overdose, Hypoglycaemia, Hypotension, Suicide Attempt, Sopor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Apidra Optiset
    Start date: 2012-05-23
    End date: 2012-05-23

Apidra Optiset
    Dosage: dose reported as 18iu, 26iu and 26iu

Apidra Optiset
    Start date: 2012-05-23
    End date: 2012-05-23

Apidra Optiset
    Dosage: dose reported as 18iu, 26iu and 26iu

Depakene
    Dosage: dose:60 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetine Hydrochloride
    Dosage: dose:56 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetine Hydrochloride
    Administration route: Oral

Duloxetine Hydrochloride
    Dosage: dose:56 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetine Hydrochloride
    Administration route: Oral

Humalog
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Dosage: dose:14 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Administration route: Oral

Lyrica
    Dosage: dose:14 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Administration route: Oral
    Indication: Diabetic Neuropathy

Optiset
    Indication: Device Therapy

Optiset
    Start date: 2012-05-23
    End date: 2012-05-23

Tramadol HCL
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Valium
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Other drugs received by patient: Ramipril; Lantus



Possible Depakene side effects in 12 year old female

Reported by a consumer/non-health professional from Brazil on 2012-07-05

Patient: 12 year old female, weighing 56.0 kg (123.2 pounds)

Reactions: Incorrect Dose Administered

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Depakene
    Dosage: 1 tablet per night
    Administration route: Oral
    Indication: Convulsion

Depakene
    Dosage: 4 tablets at once
    Start date: 2012-07-02

Other drugs received by patient: Unspecified Drug



Possible Depakene side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-03

Patient: 67 year old female

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Acetaminophen
    Indication: Analgesic Therapy
    Start date: 2012-01-01
    End date: 2012-05-07

Acetaminophen
    Indication: Antipyresis
    Start date: 2012-01-01
    End date: 2012-05-07

Albumin Tannate
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-27
    End date: 2012-05-07

Alfarol
    Indication: Osteoporosis
    Start date: 2012-04-19
    End date: 2012-05-07

Ambisome
    Indication: Fungal Infection
    Start date: 2012-04-25
    End date: 2012-05-04

Ambisome
    Indication: Device Related Infection
    Start date: 2012-04-25
    End date: 2012-05-04

Buprenorphine HCL

Cefazolin Sodium
    Indication: Prophylaxis Against Diarrhoea
    Start date: 2012-04-19
    End date: 2012-05-07

Clindamycin
    Indication: Meningitis
    Start date: 2012-04-11
    End date: 2012-05-06

Clindamycin
    Indication: Psoas Abscess
    Start date: 2012-04-11
    End date: 2012-05-06

Depakene
    Indication: Convulsion
    Start date: 2012-04-13
    End date: 2012-05-07

Lansoprazole
    Indication: Gastric Ulcer
    Start date: 2012-03-21
    End date: 2012-05-07

Lendormin
    Indication: Insomnia
    Start date: 2012-04-21

Meropenem
    Start date: 2012-04-11
    End date: 2012-04-20

Meropenem
    Start date: 2012-04-11
    End date: 2012-04-20

Meropenem
    Start date: 2012-04-27
    End date: 2012-05-06

Meropenem
    Start date: 2012-04-27
    End date: 2012-05-06

Meropenem
    Indication: Meningitis
    Start date: 2012-01-17
    End date: 2012-02-16

Meropenem
    Indication: Psoas Abscess
    Start date: 2012-01-17
    End date: 2012-02-16

Prodif
    Start date: 2012-04-11
    End date: 2012-04-23

Vancomycin Hydrochloride
    Indication: Meningitis
    Start date: 2012-02-07
    End date: 2012-02-15

Vancomycin Hydrochloride
    Start date: 2012-03-07
    End date: 2012-04-09

Vancomycin Hydrochloride
    Start date: 2012-04-27
    End date: 2012-05-06

Vancomycin Hydrochloride
    Start date: 2012-03-07
    End date: 2012-04-09

Vancomycin Hydrochloride
    Indication: Psoas Abscess
    Start date: 2012-02-07
    End date: 2012-02-15

Vancomycin Hydrochloride
    Start date: 2012-04-27
    End date: 2012-05-06

Other drugs received by patient: Prednisolone Sodium Succinate INJ; Concentrated Human RED Blood Cells; Fresh Frozen Human Plazma



Possible Depakene side effects in female

Reported by a physician from Japan on 2012-06-26

Patient: female

Reactions: Drug Eruption, Lymphadenopathy, Hepatic Function Abnormal, Fibrin Degradation Products Increased, Disseminated Intravascular Coagulation, Blood Albumin Decreased, Pyrexia, Malaise, Blood Fibrinogen Decreased, Fibrin D Dimer Increased, C-Reactive Protein Increased, Decreased Appetite, Blood Alkaline Phosphatase Increased, Viral Infection, Kidney Enlargement, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Blood Cholinesterase Decreased, Protein Total Decreased, Local Swelling, Hepatic Enzyme Increased, Varicella Virus Test Positive, Herpes Simplex Serology Positive, Aspartate Aminotransferase Increased, Platelet Count Decreased, Leucine Aminopeptidase Increased, Meningitis Aseptic

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Dosage: 600mg per day
    Administration route: Oral
    Indication: Bipolar II Disorder

Lamictal
    Dosage: 25mg twice per day
    Administration route: Oral
    Indication: Bipolar II Disorder
    Start date: 2012-05-07
    End date: 2012-05-23

Other drugs received by patient: Dogmatyl; Risperdal; Desyrel; Clonazepam; Pursennid; Magmitt



Possible Depakene side effects in female

Reported by a pharmacist from Japan on 2012-06-20

Patient: female

Reactions: Drug Eruption, Hepatic Function Abnormal, Lymphadenopathy, Fibrin Degradation Products Increased, Disseminated Intravascular Coagulation, Blood Albumin Decreased, Pyrexia, Blood Fibrinogen Decreased, C-Reactive Protein Increased, Fibrin D Dimer Increased, Blood Alkaline Phosphatase Increased, Viral Infection, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Blood Cholinesterase Decreased, Protein Total Decreased, Local Swelling, Hepatic Enzyme Increased, Varicella Virus Test Positive, Herpes Simplex Serology Positive, Aspartate Aminotransferase Increased, Platelet Count Decreased, Leucine Aminopeptidase Increased, Meningitis Aseptic

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Dosage: 600mg per day
    Administration route: Oral
    Indication: Bipolar II Disorder

Lamictal
    Dosage: 25mg twice per day
    Administration route: Oral
    Indication: Bipolar II Disorder
    Start date: 2012-05-07
    End date: 2012-05-23

Other drugs received by patient: Clonazepam; Dogmatyl; Pursennid; Risperdal; Magmitt; Desyrel



Possible Depakene side effects in 61 year old male

Reported by a physician from Japan on 2012-06-18

Patient: 61 year old male

Reactions: Anaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Depakene
    Dosage: daily dose: 400 mg
    Administration route: Oral
    Indication: Partial Seizures With Secondary Generalisation
    Start date: 2012-03-09
    End date: 2012-04-19

Keppra
    Administration route: Oral
    Indication: Partial Seizures With Secondary Generalisation
    Start date: 2012-03-19
    End date: 2012-03-25

Keppra
    Administration route: Oral
    Start date: 2012-03-11
    End date: 2012-03-18

Other drugs received by patient: Phenobarbital TAB; Lamictal; Diapp



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-06-18

Patient: male

Reactions: Hypokinesia, Intentional Overdose, Hypoglycaemia, Hypotension, Suicide Attempt, Sopor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Apidra
    Dosage: once
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-05-23
    End date: 2012-05-23

Apidra
    Indication: Suicide Attempt

Depakene
    Dosage: once
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetime Hydrochloride
    Dosage: once
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetime Hydrochloride
    Indication: Suicide Attempt

Humalog
    Dosage: once
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Dosage: once
    Administration route: Oral
    Indication: Diabetic Neuropathy
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Indication: Suicide Attempt

Optiset
    Dosage: 3 in 1 day, once
    Indication: Device Therapy
    Start date: 2012-05-23
    End date: 2012-05-23

Tramadol HCL
    Dosage: once
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Valium
    Dosage: once
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Other drugs received by patient: Ramipril; Lantus



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-06-15

Patient: male

Reactions: Hypokinesia, Intentional Overdose, Hypotension, Hypoglycaemia, Suicide Attempt, Sopor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Apidra
    Dosage: once
    Indication: Type 1 Diabetes Mellitus
    Start date: 2012-05-23
    End date: 2012-05-23

Apidra
    Indication: Suicide Attempt

Depakene
    Dosage: once
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetime Hydrochloride
    Dosage: once
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetime Hydrochloride
    Indication: Suicide Attempt

Humalog
    Dosage: once
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Dosage: once
    Administration route: Oral
    Indication: Diabetic Neuropathy
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Indication: Suicide Attempt

Optiset
    Dosage: 3 in 1 day, once
    Indication: Device Therapy
    Start date: 2012-05-23
    End date: 2012-05-23

Tramadol HCL
    Dosage: once
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Valium
    Dosage: once
    Administration route: Oral
    Indication: Suicide Attempt
    Start date: 2012-05-23
    End date: 2012-05-23

Other drugs received by patient: Ramipril



Possible Depakene side effects in 40 year old male

Reported by a physician from Italy on 2012-06-15

Patient: 40 year old male

Reactions: Hypokinesia, Intentional Overdose, Hypoglycaemia, Hypotension, Suicide Attempt, Sopor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Apidra Optiset
    Dosage: dose reported as 18iu, 26iu and 26iu

Apidra Optiset
    Dosage: dose reported as 18iu, 26iu and 26iu

Apidra Optiset
    Start date: 2012-05-23
    End date: 2012-05-23

Apidra Optiset
    Start date: 2012-05-23
    End date: 2012-05-23

Depakene
    Dosage: dose:60 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetine Hydrochloride
    Administration route: Oral

Duloxetine Hydrochloride
    Dosage: dose:56 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetine Hydrochloride
    Administration route: Oral

Duloxetine Hydrochloride
    Dosage: dose:56 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Humalog
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Dosage: dose:14 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Administration route: Oral

Lyrica
    Dosage: dose:14 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Administration route: Oral
    Indication: Diabetic Neuropathy

Optiset
    Indication: Device Therapy

Optiset
    Start date: 2012-05-23
    End date: 2012-05-23

Tramadol HCL
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Valium
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Other drugs received by patient: Ramipril; Lantus



Possible Depakene side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-06-13

Patient: 40 year old male

Reactions: Hypokinesia, Intentional Overdose, Hypoglycaemia, Hypotension, Suicide Attempt, Sopor

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Apidra Optiset
    Dosage: dose reported as 18iu, 26iu and 26iu

Apidra Optiset
    Dosage: dose reported as 18iu, 26iu and 26iu

Apidra Optiset
    Start date: 2012-05-23
    End date: 2012-05-23

Apidra Optiset
    Start date: 2012-05-23
    End date: 2012-05-23

Depakene
    Dosage: dose:60 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetine Hydrochloride
    Dosage: dose:56 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetine Hydrochloride
    Dosage: dose:56 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Duloxetine Hydrochloride
    Administration route: Oral

Duloxetine Hydrochloride
    Administration route: Oral

Humalog
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Dosage: dose:14 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Dosage: dose:14 unit(s)
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Lyrica
    Administration route: Oral
    Indication: Diabetic Neuropathy

Lyrica
    Administration route: Oral

Optiset
    Indication: Device Therapy

Optiset
    Start date: 2012-05-23
    End date: 2012-05-23

Tramadol HCL
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Valium
    Administration route: Oral
    Start date: 2012-05-23
    End date: 2012-05-23

Other drugs received by patient: Ramipril



Possible Depakene side effects in female

Reported by a physician from Japan on 2012-06-12

Patient: female

Reactions: Drug Eruption, Hepatic Function Abnormal, Lymphadenopathy, Fibrin Degradation Products Increased, Disseminated Intravascular Coagulation, Blood Albumin Decreased, Pyrexia, Blood Fibrinogen Decreased, Fibrin D Dimer Increased, C-Reactive Protein Increased, Blood Alkaline Phosphatase Increased, Viral Infection, Alanine Aminotransferase Increased, Blood Lactate Dehydrogenase Increased, Blood Cholinesterase Decreased, Protein Total Decreased, Local Swelling, Hepatic Enzyme Increased, Varicella Virus Test Positive, Herpes Simplex Serology Positive, Aspartate Aminotransferase Increased, Platelet Count Decreased, Leucine Aminopeptidase Increased, Meningitis Aseptic

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Dosage: 600mg per day
    Administration route: Oral
    Indication: Bipolar II Disorder

Lamictal
    Dosage: 25mg per day
    Administration route: Oral
    Indication: Bipolar II Disorder
    Start date: 2012-05-07
    End date: 2012-05-23

Other drugs received by patient: Dogmatyl; Desyrel; Magmitt; Clonazepam; Risperdal; Pursennid



Possible Depakene side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-06-05

Patient: 73 year old female

Reactions: Rhabdomyolysis, Hypercreatininaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-08
    End date: 2011-12-13

Escitalopram
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-11-07
    End date: 2011-12-13

Fluvastatin
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-03-09
    End date: 2011-12-13

Pantoprazole
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-07-11
    End date: 2011-12-13

Tramadol HCL
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-12-07
    End date: 2011-12-13

Tramadol Hydrochloride and Acetaminophen
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-01
    End date: 2011-12-13



Possible Depakene side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-06-01

Patient: 73 year old female

Reactions: Rhabdomyolysis, Hypercreatininaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-08
    End date: 2011-12-13

Escitalopram
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-11-07
    End date: 2011-12-13

Fluvastatin
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-03-09
    End date: 2011-12-13

Pantoprazole
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-07-11
    End date: 2011-12-13

Tramadol HCL
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-12-07
    End date: 2011-12-13

Ultracet
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-01
    End date: 2011-12-13



Possible Depakene side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-05-31

Patient: 73 year old female

Reactions: Rhabdomyolysis, Hypercreatinaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Dosage: 400 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-08
    End date: 2011-12-13

Escitalopram
    Dosage: 5 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-11-07
    End date: 2011-12-13

Fluvastatin
    Dosage: 80 mg
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-03-09
    End date: 2011-12-13

Pantoprazole
    Dosage: 40 mg
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-07-11
    End date: 2011-12-13

Tramadol HCL
    Dosage: 150 mg
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-12-07
    End date: 2011-12-13

Ultracet
    Dosage: 3 df
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-01
    End date: 2011-12-13



Possible Depakene side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-05-29

Patient: 73 year old female

Reactions: Rhabdomyolysis, Hypercreatininaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-08
    End date: 2011-12-13

Escitalopram
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-11-07
    End date: 2011-12-13

Fluvastatin
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-03-09
    End date: 2011-12-13

Pantoprazole
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-07-11
    End date: 2011-12-13

Tramadol HCL
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-12-07
    End date: 2011-12-13

Ultracet
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-01
    End date: 2011-12-13



Possible Depakene side effects in female

Reported by a physician from France on 2012-05-24

Patient: female

Reactions: Pruritus, Lymphadenopathy, Drug Interaction, Pyrexia, Erythema, Face Oedema, Conjunctival Hyperaemia, Dermatitis Bullous, Skin Disorder, Toxic Epidermal Necrolysis, Vulvar Erosion, Nikolsky's Sign, Mucosal Erosion, Respiratory Tract Congestion, Lacrimation Increased, Rash Maculo-Papular, Toxic Skin Eruption, Keratitis, Inflammation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2008-12-21
    End date: 2009-04-18

Lamictal
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2009-03-31
    End date: 2009-04-15

Other drugs received by patient: Norlevo; Clobazam



Possible Depakene side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-05-18

Patient: 73 year old female

Reactions: Rhabdomyolysis, Hypercreatininaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Depakene
    Dosage: 400 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-08
    End date: 2011-12-13

Escitalopram
    Dosage: 5 mg
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-11-07
    End date: 2011-12-13

Fluvastatin
    Dosage: 80 mg
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-03-09
    End date: 2011-12-13

Pantoprazole
    Dosage: 40 mg
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-07-11
    End date: 2011-12-13

Tramadol Hydrochloride
    Dosage: 150 mg
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-12-07
    End date: 2011-12-13

Ultracet
    Dosage: 3 df
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-01
    End date: 2011-12-13



Possible Depakene side effects in 61 year old male

Reported by a physician from Japan on 2012-05-17

Patient: 61 year old male

Reactions: Anaemia

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Depakene
    Dosage: daily dose: 8ml
    Administration route: Oral
    Indication: Partial Seizures With Secondary Generalisation
    Start date: 2012-03-09
    End date: 2012-04-19

Keppra
    Administration route: Oral
    Start date: 2012-03-11
    End date: 2012-03-18

Keppra
    Administration route: Oral
    Indication: Partial Seizures With Secondary Generalisation
    Start date: 2012-03-19
    End date: 2012-03-25

Other drugs received by patient: Lamictal; Phenobarbital TAB; Diapp



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