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Hydroxyurea (Hydroxyurea) - Drug Withdrawal Syndrome Neonatal - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Drug Withdrawal Syndrome Neonatal (6)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Hydroxyurea where reactions include drug withdrawal syndrome neonatal. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Hydroxyurea side effects in male

Reported by a physician from Germany on 2012-05-22

Patient: male, weighing 2.3 kg (5.1 pounds)

Reactions: Premature Baby, Oesophageal Atresia, Maternal Exposure Timing Unspecified, Drug Withdrawal Syndrome Neonatal

Drug(s) suspected as cause:
Omeprazole

Meperidine HCL
    Dosage: unk

Melperon ^CT-Arzneimittel^
    Dosage: 1tablet,tid
    End date: 2010-02-18

Folsaeure ^hevert^

Morphine Sulfate
    Dosage: 40 mg, daily
    Start date: 2009-10-13

Antacida FNA
    Dosage: unk

Morphine Sulfate
    Dosage: 300 mg,daily
    End date: 2010-06-13

Hydroxyurea
    Dosage: 1000 mg,daily
    Start date: 2009-10-13
    End date: 2010-02-18

Agomelatine
    Dosage: 25 mg, daily
    End date: 2010-02-18

Haldol
    Dosage: unk
    End date: 2010-02-18



Possible Hydroxyurea side effects in male

Reported by a physician from Germany on 2012-05-16

Patient: male, weighing 2.3 kg (5.1 pounds)

Reactions: Oesophageal Atresia, Drug Withdrawal Syndrome Neonatal

Drug(s) suspected as cause:
Meperidine HCL
    Dosage: unk, see text
    Indication: Maternal Exposure During Pregnancy
    Start date: 2009-10-13
    End date: 2010-06-13

Valdoxan
    Dosage: 25 mg, daily
    Indication: Maternal Exposure During Pregnancy
    End date: 2010-02-18

Morphine
    Dosage: 300 mg, daily
    Indication: Maternal Exposure During Pregnancy
    End date: 2010-06-13

Hydroxyurea
    Dosage: 1000 mg, daily
    Indication: Maternal Exposure During Pregnancy
    Start date: 2009-10-13
    End date: 2010-02-18

Melperon
    Dosage: 1 tablet, tid
    Indication: Maternal Exposure During Pregnancy
    End date: 2010-02-18

Morphine
    Dosage: 40 mg, daily
    Start date: 2009-10-13

Other drugs received by patient: Antacida FNA / 01021901 /; Folic Acid; Omep / 00661201 /; Haldol



Possible Hydroxyurea side effects in male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-15

Patient: male

Reactions: Maternal Drugs Affecting Foetus, Oesophageal Atresia, Drug Withdrawal Syndrome Neonatal

Drug(s) suspected as cause:
Morphine
    Dosage: 300 [mg/d (bis 40) ]/ slow dosage increase from 40 to 300 mg/d max since 20th gw^
    Indication: Pain
    Start date: 2009-10-13
    End date: 2010-06-13

Meperidine HCL
    Dosage: up to 9 times per day (max), only if needed
    Indication: Pain
    Start date: 2009-10-13
    End date: 2010-06-13

Hydroxyurea
    Dosage: 1000 [mg/d ]/1000 mg was the maximum dosage
    Indication: Sickle Cell Anaemia
    Start date: 2009-10-13
    End date: 2010-02-18

Melperon
    Dosage: 3x1 tbl./d;dosage unknown
    Indication: Depression
    End date: 2010-02-18

Valdoxan
    Dosage: 25 mg daily
    Indication: Depression
    End date: 2010-02-18

Other drugs received by patient: Haldol; Omep / 00661201 /; Antacids; Folic Acid



Possible Hydroxyurea side effects in male

Reported by a consumer/non-health professional from Germany on 2012-05-11

Patient: male, weighing 2.0 kg (4.4 pounds)

Reactions: Oesophageal Atresia, Drug Withdrawal Syndrome Neonatal

Drug(s) suspected as cause:
Valdoxan
    End date: 2010-02-18

Morphine Sulfate
    Dosage: also orally
    Start date: 2009-10-14
    End date: 2010-06-13

Hydroxyurea
    Start date: 2009-10-14
    End date: 2010-02-18

Melperone HCL
    Dosage: 1df:3x1 tablet
    End date: 2010-02-18

Haldol

Meperidine HCL
    Start date: 2009-10-14
    End date: 2010-06-13

Other drugs received by patient: Folic Acid; Omeprazole



Possible Hydroxyurea side effects in male

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

Patient: male, weighing 2.3 kg (5.1 pounds)

Reactions: Oesophageal Atresia, Drug Withdrawal Syndrome Neonatal, Congenital Choroid Plexus Cyst, Foetal Exposure Timing Unspecified

Drug(s) suspected as cause:
Morphine
    Dosage: slow dosage increase from 40 to 3oo mg/d max since 20th gw
    Indication: Pain
    Start date: 2009-10-13
    End date: 2010-06-13

Melperone
    Dosage: 3x1 tbl./d; dosage unknown
    Indication: Depression
    End date: 2010-02-18

Meperidine HCL
    Dosage: up to 9 times per day (max), only if needed
    Indication: Pain
    Start date: 2009-10-13

Hydroxyurea
    Dosage: varying doses up to max. 1000 mg/day
    Indication: Sickle Cell Anaemia
    Start date: 2009-10-13
    End date: 2010-02-18

Antidepressants
    Indication: Depression
    End date: 2010-02-18

Other drugs received by patient: Omeprazole; Antacids; Haldol; Folic Acid



Possible Hydroxyurea side effects in male

Reported by a physician from Germany on 2012-05-09

Patient: male

Reactions: Oesophageal Atresia, Drug Withdrawal Syndrome Neonatal

Drug(s) suspected as cause:
Melperone

Morphine

Hydroxyurea

Meperidine HCL

Valdoxan

Other drugs received by patient: Haldol; Folic Acid; Antacida; Omeprazole

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