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Epzicom (Abacavir / Lamivudine) - Foetal Exposure During Pregnancy - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Foetal Exposure During Pregnancy (21)

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

Possible Epzicom side effects in male

Reported by a physician from France on 2012-08-15

Patient: male

Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Dysphonia, Oral Candidiasis, Foetal Heart Rate Disorder, Oesophageal Atresia, Venous Thrombosis Limb, Cough, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event

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

Epzicom
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-15

Patient: female, weighing 1.9 kg (4.2 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Epzicom
    Indication: Antiretroviral Therapy

Kaletra
    Indication: Antiretroviral Therapy



Possible Epzicom side effects in

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient:

Reactions: LOW Birth Weight Baby, Foetal Growth Restriction, Small FOR Dates Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Norvir
    Dosage: 200 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Prezista
    Dosage: 1200 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Epzicom
    Dosage: 1 df, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Retrovir
    Dosage: 2000 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16

Isentress
    Dosage: 800 mg, qd
    Indication: HIV Infection
    Start date: 2011-11-15
    End date: 2012-05-16

Intelence
    Dosage: 400 mg, qd
    Start date: 2011-11-15
    End date: 2012-05-16



Possible Epzicom side effects in female

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

Patient: female, weighing 0.4 kg (0.9 pounds)

Reactions: Neural Tube Defect, Spina Bifida, Foetal Exposure During Pregnancy, Arnold-Chiari Malformation, Cerebral Ventricle Dilatation, Meningomyelocele

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Indication: HIV Infection
    Start date: 2010-12-13

Viramune
    Dosage: 400mgd per day
    Indication: HIV Infection



Possible Epzicom side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21

Patient: female

Reactions: Foetal Growth Restriction, Small FOR Dates Baby, Foetal Exposure During Pregnancy

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

Retrovir
    Indication: Maternal Exposure Timing Unspecified

Intelence
    Indication: Maternal Exposure Timing Unspecified

Norvir
    Indication: Maternal Exposure Timing Unspecified

Epzicom
    Indication: Maternal Exposure Timing Unspecified

Isentress
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-24

Patient:

Reactions: Neural Tube Defect, Foetal Exposure During Pregnancy, Meningomyelocele, Cerebral Ventricle Dilatation

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Indication: HIV Infection
    Start date: 2010-12-13

Viramune
    Dosage: 400mgd per day
    Indication: HIV Infection



Possible Epzicom side effects in

Reported by a consumer/non-health professional from Japan on 2012-05-09

Patient:

Reactions: Premature Baby, Live Birth, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Norvir
    Indication: Antiretroviral Therapy
    Start date: 2009-11-05
    End date: 2010-12-27

Reyataz
    Indication: Antiretroviral Therapy
    Start date: 2009-11-05
    End date: 2010-12-27

Epzicom
    Indication: Antiretroviral Therapy
    Start date: 2009-11-05
    End date: 2010-12-27



Possible Epzicom side effects in male

Reported by a physician from France on 2012-02-17

Patient: male

Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Oral Candidiasis, Foetal Heart Rate Disorder, Dysphonia, Oesophageal Atresia, Venous Thrombosis Limb, Cough, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Epzicom
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-08

Patient: male

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Congenital Choroid Plexus Cyst

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

Epzicom
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in male

Reported by a physician from Japan on 2012-01-31

Patient: male, weighing 2.7 kg (5.9 pounds)

Reactions: Foetal Exposure During Pregnancy, Anaemia

Drug(s) suspected as cause:
Retrovir
    Dosage: 20.8mg per day
    Administration route: Oral
    Indication: Prophylaxis Against HIV Infection
    Start date: 2011-11-29
    End date: 2012-01-09

Epzicom
    Dosage: 1iuax per day
    Indication: HIV Infection

Norvir
    Dosage: 1iuax per day
    Indication: HIV Infection

Retrovir
    Dosage: 400mg per day
    Start date: 2011-11-29
    End date: 2011-11-29

Lexiva
    Dosage: 2iuax per day
    Indication: HIV Infection



Possible Epzicom side effects in male

Reported by a physician from France on 2012-01-04

Patient: male

Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Dysphonia, Fungal Infection, Oral Candidiasis, Foetal Heart Rate Disorder, Oesophageal Atresia, Venous Thrombosis Limb, Oxygen Saturation Decreased, Cough

Adverse event resulted in: life threatening event

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

Retrovir
    Indication: Maternal Exposure Timing Unspecified

Epzicom
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-12-22

Patient: 35 year old female

Reactions: Liver Function Test Abnormal, Foetal Exposure During Pregnancy, Nephropathy

Drug(s) suspected as cause:
Epzicom
    Dosage: 1tab per day
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25

Kaletra
    Dosage: 4tab per day
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2011-11-25



Possible Epzicom side effects in male

Reported by a physician from France on 2011-12-21

Patient: male

Reactions: Foetal Exposure During Pregnancy, Foetal Cardiac Disorder, Tracheomalacia, Salivary Hypersecretion, Oesophageal Atresia, Cough, Oxygen Saturation Decreased, Laryngeal Disorder

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Epzicom
    Dosage: 600mg per day
    Indication: HIV Infection
    Start date: 2011-05-04
    End date: 2011-09-11

Kaletra
    Dosage: 2unit per day
    Indication: HIV Infection
    Start date: 2011-05-04
    End date: 2011-09-11



Possible Epzicom side effects in male

Reported by a physician from France on 2011-12-21

Patient: male

Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Oral Candidiasis, Dysphonia, Foetal Heart Rate Disorder, Oesophageal Atresia, Venous Thrombosis Limb, Cough, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event

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

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in male

Reported by a physician from France on 2011-12-09

Patient: male

Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Dysphonia, Foetal Heart Rate Disorder, Oral Candidiasis, Oesophageal Atresia, Venous Thrombosis Limb, Cough, Oxygen Saturation Decreased

Adverse event resulted in: life threatening event

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

Epzicom
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in male

Reported by a physician from Japan on 2011-12-08

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: Anaemia Neonatal, Foetal Exposure During Pregnancy, Neonatal Tachypnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Retrovir
    Dosage: 2amp per day
    Indication: HIV Infection
    Start date: 2010-06-29
    End date: 2010-06-29

Reyataz
    Dosage: 300mg per day
    Indication: HIV Infection
    Start date: 2009-11-01
    End date: 2009-12-22

Kaletra
    Dosage: 2tab twice per day
    Indication: HIV Infection
    Start date: 2009-12-23

Norvir
    Dosage: 100mg per day
    Indication: HIV Infection
    Start date: 2009-11-01
    End date: 2009-12-22

Epzicom
    Dosage: 1tab per day
    Indication: HIV Infection
    Start date: 2009-11-01
    End date: 2011-02-08

Other drugs received by patient: Magnesium Sulfate; Efavirenz; Ritodrine Hydrochloride; Ritodrine Hydrochloride



Possible Epzicom side effects in male

Reported by a physician from Japan on 2011-12-06

Patient: male

Reactions: Anaemia, Foetal Exposure During Pregnancy, Tachypnoea

Adverse event resulted in: hospitalization

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

Epzicom
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified

Norvir
    Indication: Maternal Exposure Timing Unspecified

Reyataz
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in male

Reported by a physician from France on 2011-11-14

Patient: male

Reactions: Regurgitation, Drooling, Foetal Exposure During Pregnancy, Tracheomalacia, Fungal Infection, Foetal Heart Rate Disorder, Oral Candidiasis, Dysphonia, Oesophageal Atresia, Venous Thrombosis Limb, Oxygen Saturation Decreased, Cough

Adverse event resulted in: life threatening event

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

Epzicom
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-09

Patient: female

Reactions: Underweight, Foetal Exposure During Pregnancy

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

Reyataz
    Indication: Maternal Exposure Timing Unspecified

Epzicom
    Indication: Maternal Exposure Timing Unspecified

Retrovir
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-07

Patient: male

Reactions: Penile Curvature, Foetal Exposure During Pregnancy, Hypospadias

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

Truvada
    Indication: Maternal Exposure Timing Unspecified

Kaletra
    Indication: Maternal Exposure Timing Unspecified

Epzicom
    Indication: Maternal Exposure Timing Unspecified



Possible Epzicom side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-04

Patient: male

Reactions: Penile Curvature, Foetal Exposure During Pregnancy, Maternal Exposure During Pregnancy, Hypospadias

Drug(s) suspected as cause:
Kaletra
    Indication: Maternal Exposure During Pregnancy

Epzicom
    Indication: Maternal Exposure During Pregnancy

Truvada
    Indication: Maternal Exposure During Pregnancy

Invirase
    Indication: Maternal Exposure During Pregnancy

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