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Premarketing Surveillance of Oral Ibuprofen Solution in Febrile Children

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Abstract

Objective

Ibuprofen is as effective as paracetamol (acetaminophen) as an antipyretic and analgesic agent in paediatric patients. Ibuprofen is considered to be well tolerated; however, there are reports on gastrointestinal bleeding or renal adverse effects among children treated with ibuprofen. Oral ibuprofen suspension was recently registered and approved by the Ministry of Health in Israel as an antipyretic and analgesic agent. Before distribution of the drug to pharmacies, we aimed to follow possible adverse effects among children receiving ibuprofen suspension in several paediatric wards and clinics.

Design

Children with fever needing antipyretic medication received ibuprofen oral suspension 5 to 10 mg/kg/dose. In each case the age of the patient, gender, diagnosis, number of ibuprofen doses, duration of treatment and any adverse reactions were reported.

Results

1564 children from 14 paediatric wards (11 hospitals) and from five paediatric and family clinics participated in the study; 882 males and 682 females. The patients, aged 3.6 ± 4.2 years (range 1 month to 16.5 years), received 2.4 ± 3 (range 1 to 22) doses of ibuprofen suspension for 1.56 ± 2.11 (range 1 to 20) days. Adverse reactions were reported among 26 patients (1.66%) [95% confidence interval (CI) 1.1–2.4]; 18 children (1.15%) [95% CI 0.7–1.8] vomited immediately after the administration of the drug and it was not readministered. Two children (0.12%) [95% CI 0.02–0.46] had abdominal pain that resolved spontaneously, two patients reported nausea, and two other children had diarrhoea. Eight children (0.51%) reported experiencing a ‘bitter taste’ from the medication, of whom one patient discontinued the medication while the other seven continued it.

Conclusions

The adverse reactions following administration of oral ibuprofen suspension reported in our study were low in frequency, mild and disappeared spontaneously. However, continuing reporting on its tolerability is needed.

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Notes

  1. 1Trade name is used for identification purposes only and does not imply product endorsement.

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Acknowledgements

The study was supported by Teva-Abic Marketing Ltd, Netanya, Israel. The authors wish to thank Ms Hanna Gotlieb and Ms Pnina Mugami from Teva-Abic Ltd and Ms Malka Guttman from the Clinical Pharmacology Unit, Assaf Harofeh Medical Center, for supporting and encouraging this study.

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Authors and Affiliations

  1. Clinical Pharmacology Unit, Assaf Harofeh Medical Center, Zerifin, Israel

    M. Berkovitch & M. Bulkowstein

  2. Pediatric Emergency Unit, Soroka Medical Center, Beer-Sheva, Israel

    J. Press

  3. Department of Pediatrics, Western Galilee Hospital, Nahariya, Israel

    L. Even

  4. Pediatric Daycare, Kaplan Medical Center, Rehovot, Israel

    J. Barash

  5. Department of Pediatrics, Rambam Medical Center, Haifa, Israel

    R. Brik & M. Mosleh

  6. Department of Pediatrics, The E. Wolfson Medical Center, Holon, Israel

    D. Tasher

  7. Department of Pediatrics, Ha’Emek Medical Center, Haifa, Israel

    R. Marom

  8. Department of Pediatrics, Sieff Hospital, Haifa, Israel

    A. S. Luder

  9. Department of Pediatrics, Carmel Medical Center, Haifa, Israel

    Y. Hecht

  10. Pediatric Emergency Department, Shiba Medical Center, Tal-Hashomer, Israel

    M. Rubinshtein

  11. Department of Pediatrics, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel

    S. Ben-Shachar

  12. Department of Pediatrics, Sapir Medical Center, Kfar-saba, Israel

    R. Talmor, A. Zviel, A. Kiro, L. Piglansky, V. Pinsk & Y. Uziel

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  1. M. Berkovitch
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  2. J. Press
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  3. M. Bulkowstein
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  4. L. Even
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  5. J. Barash
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  6. R. Brik
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  7. D. Tasher
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  8. R. Marom
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  9. A. S. Luder
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  10. Y. Hecht
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  11. M. Rubinshtein
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  12. M. Mosleh
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  13. S. Ben-Shachar
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  14. R. Talmor
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  15. A. Zviel
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  16. A. Kiro
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  17. L. Piglansky
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  18. V. Pinsk
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  19. Y. Uziel
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Corresponding author

Correspondence to M. Berkovitch.

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Berkovitch, M., Press, J., Bulkowstein, M. et al. Premarketing Surveillance of Oral Ibuprofen Solution in Febrile Children. Clin. Drug Investig. 21, 821–825 (2001). https://doi.org/10.2165/00044011-200121120-00004

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  • DOI: https://doi.org/10.2165/00044011-200121120-00004

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