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Depakene (Valproic Acid) - Foetal Exposure During Pregnancy - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Foetal Exposure During Pregnancy (23)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Depakene (Valproic Acid) where reactions include foetal exposure during pregnancy. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Depakene side effects in male

Reported by a physician from Italy on 2012-08-10

Patient: male

Reactions: Spina Bifida, Premature Baby, Foetal Exposure During Pregnancy, Meningomyelocele

Drug(s) suspected as cause:
Depakene
    Indication: Maternal Exposure Timing Unspecified

Depakene
    Indication: Bipolar Disorder



Possible Depakene side effects in

Reported by a physician from France on 2012-08-03

Patient:

Reactions: Clubbing, Retrognathia, Congenital Renal Cyst, Multiple Congenital Abnormalities, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Keppra
    Dosage: 250mg per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-04-06

Depakene
    Dosage: 500mg twice per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-11
    End date: 2012-02-01

Lamictal
    Dosage: 25mg twice per day
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-04-06



Possible Depakene side effects in female

Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-07-13

Patient: female

Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy, Limb Malformation

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-20

Patient: female

Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy, Congenital Teratoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Clobazam
    Dosage: 5 mg in the morning and 10 mg in the evening
    Start date: 2009-02-01
    End date: 2009-03-01

Clobazam
    Start date: 2009-03-01
    End date: 2009-03-31

Keppra
    End date: 2009-03-01

Depakene
    End date: 2009-03-31

Keppra
    Start date: 2009-03-01
    End date: 2009-03-31

Clobazam
    End date: 2009-02-01



Possible Depakene side effects in

Reported by a consumer/non-health professional from Brazil on 2012-06-04

Patient:

Reactions: Ultrasound Scan Abnormal, Dandy-Walker Syndrome, Foetal Exposure During Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in

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

Patient:

Reactions: Foetal Anticonvulsant Syndrome, Congenital Hand Malformation, Foetal Exposure During Pregnancy, Exomphalos, Limb Malformation, Neck Deformity, Talipes, Abortion Induced, Foetal Malformation

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in

Reported by a consumer/non-health professional from Brazil on 2012-06-01

Patient:

Reactions: Dandy-Walker Syndrome, Foetal Exposure During Pregnancy

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-05-14

Patient: male

Reactions: Foetal Exposure During Pregnancy, Hypospadias

Drug(s) suspected as cause:
Levothyroxine Sodium
    Indication: Maternal Exposure Timing Unspecified

Tegretol
    Indication: Maternal Exposure Timing Unspecified

Depakene
    Indication: Maternal Exposure Timing Unspecified

Diethyl-Stilbestrol TAB
    Indication: Maternal Exposure Timing Unspecified



Possible Depakene side effects in female

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-05-11

Patient: female

Reactions: Congenital Hand Malformation, Blindness Congenital, Foetal Exposure During Pregnancy, Congenital Anomaly, Heart Disease Congenital, Congenital Hearing Disorder, Gastrostomy

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-04-25

Patient: male

Reactions: Polydactyly, Foetal Exposure During Pregnancy, Finger Deformity

Drug(s) suspected as cause:
Depakene
    Indication: Product Used FOR Unknown Indication

Depakene
    Indication: Maternal Exposure Timing Unspecified



Possible Depakene side effects in male

Reported by a physician from Switzerland on 2012-04-04

Patient: male, weighing 4.0 kg (8.8 pounds)

Reactions: Foetal Exposure During Pregnancy, Ill-Defined Disorder

Drug(s) suspected as cause:
Haldol
    Indication: Maternal Exposure Timing Unspecified

Abilify
    Indication: Maternal Exposure Timing Unspecified

Methadone HCL
    Indication: Maternal Exposure Timing Unspecified

Depakene
    Indication: Maternal Exposure Timing Unspecified



Possible Depakene side effects in female

Reported by a health professional (non-physician/pharmacist) from Belgium on 2012-04-03

Patient: female

Reactions: Congenital Hand Malformation, Blindness Congenital, Foetal Exposure During Pregnancy, Congenital Anomaly, Congenital Hearing Disorder, Heart Disease Congenital

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

Reported by a physician from France on 2012-03-28

Patient: male, weighing 2.7 kg (5.9 pounds)

Reactions: Weight Decreased, Metabolic Acidosis, Kidney Enlargement, Foetal Exposure During Pregnancy, Hearing Impaired, Dysplasia, Echography Abnormal, External Auditory Canal Atresia, Anogenital Warts

Drug(s) suspected as cause:
Keppra
    Indication: Epilepsy
    End date: 2010-05-01

Keppra
    Start date: 2010-01-01

Donormyl
    Indication: Poisoning Deliberate
    Start date: 2010-05-22
    End date: 2010-05-22

Urbanyl
    Indication: Epilepsy
    End date: 2010-05-01

Depakene
    Indication: Epilepsy
    End date: 2010-05-01

Other drugs received by patient: Ciprofloxacin HCL



Possible Depakene side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-27

Patient:

Reactions: Ear Malformation, Metabolic Acidosis, Kidney Enlargement, Foetal Exposure During Pregnancy, Hearing Impaired

Drug(s) suspected as cause:
Urbanyl
    Indication: Maternal Exposure Timing Unspecified

Keppra
    Indication: Maternal Exposure Timing Unspecified

Depakene
    Indication: Maternal Exposure Timing Unspecified

Doxylamine Succinate
    Indication: Maternal Exposure Timing Unspecified



Possible Depakene side effects in

Reported by a physician from Egypt on 2012-03-23

Patient:

Reactions: Caesarean Section, Haemorrhage, Foetal Exposure During Pregnancy, Sepsis, Hypoxia, Encephalitic Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

Reported by a physician from France on 2012-03-19

Patient: male

Reactions: Myoclonus, Foetal Anticonvulsant Syndrome, Dysmorphism, Speech Disorder Developmental, Foetal Exposure During Pregnancy, Hypospadias, Learning Disorder

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in

Reported by a physician from France on 2012-03-08

Patient:

Reactions: Spina Bifida, Foetal Exposure During Pregnancy, Abortion Induced

Adverse event resulted in: death

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-02-22

Patient: male

Reactions: Congenital Nose Malformation, Foetal Anticonvulsant Syndrome, Dysmorphism, Prominent Epicanthal Folds, Foetal Exposure During Pregnancy, Mental Retardation, Clinodactyly, Congenital JAW Malformation

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-01-25

Patient: male

Reactions: Foetal Anticonvulsant Syndrome, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-01-19

Patient: male

Reactions: Cardiac Murmur, Dysmorphism, Congenital Hair Disorder, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Hypertelorism of Orbit, Poor Sucking Reflex, Excessive Skin, LOW SET Ears, Hypotonia

Drug(s) suspected as cause:
Depakene



Possible Depakene side effects in male

Reported by a lawyer from Denmark on 2012-01-18

Patient: male

Reactions: Foetal Exposure During Pregnancy, Congenital Foot Malformation, Epilepsy Congenital

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Frisium
    Indication: Epilepsy

Depakene
    Indication: Epilepsy

Keppra
    Dosage: 4000 mg
    Indication: Epilepsy

Zonegran
    Dosage: 200 mg
    Indication: Epilepsy

Phenobarbital TAB
    Dosage: 180 mg
    Indication: Epilepsy



Possible Depakene side effects in male

Reported by a physician from Japan on 2011-12-05

Patient: male, weighing 3.9 kg (8.6 pounds)

Reactions: Foetal Exposure During Pregnancy, Spine Malformation

Drug(s) suspected as cause:
Lamictal
    Indication: Epilepsy

Lamictal
    Dosage: 300mg per day

Lamictal
    Dosage: 200mg per day
    Start date: 2010-11-01

Depakene
    Dosage: 600mg per day
    Indication: Epilepsy
    Start date: 2007-09-01
    End date: 2010-12-27

Lamictal
    Dosage: 400mg per day

Depakene
    Dosage: 200mg per day
    Start date: 2010-12-28
    End date: 2010-12-30

Other drugs received by patient: Phenobarbital TAB



Possible Depakene side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2011-12-05

Patient: female

Reactions: Hand Deformity, Dysmorphism, Educational Problem, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Depakene

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