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Serious skin reactions from Carbamazepine : reports from Thaivigibase

Serious skin reactions from Carbamazepine : reports from Thaivigibase. Health Product Vigilance Center (HPVC) Food and Drug Administration, Ministry of Public Health, Thailand. Introduction.

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Serious skin reactions from Carbamazepine : reports from Thaivigibase

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  1. Serious skin reactions from Carbamazepine : reports from Thaivigibase Health Product Vigilance Center (HPVC) Food and Drug Administration, Ministry of Public Health, Thailand

  2. Introduction • The most serious skin reactions reported from prescribing some group of drugs are Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). • These reactions can lead patients severely ill and finally dead.

  3. Introduction • On December 2007, US. Food and Drug Administration (FDA) issued an alert for healthcare professionals concerning the dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy.

  4. Introduction • The latest information about the genetic association of some drugs- serious reactions has been clarified. • The HLA- B*1502 allele (which caused SJS) is significantly more common in patients exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians and Thais.

  5. Introduction • Descriptive analysis of adverse reactions from carbamazepine use in Thaivigibase would be compared those reactions to the new information in Thai patients. • Proper recommendation and regulatory action would be performed from this experience.

  6. Review of Carbamazepine • Carbamazepine is labeled for use in the following indication; Bipolar I disorder, acute manic and mixed episodes, Epilepsy, Partial, generalized, and mixed types , Glossopharyngeal neuralgia and Trigeminal neuralgia.

  7. Side effects and toxicity • Carbamazepine can produce dose-related adverse effects, which include dizziness, diplopia, nausea, ataxia, and blurred vision. Rare idiosyncratic adverse effects include aplastic anemia, agranulocytosis, thrombocytopenia, Stevens-Johnson syndrome and asymptomatic elevation of liver enzymes.

  8. Objectives • To describe and characterize skin and appendage adverse drug reaction reported in patients receiving carbamazepine in Thailand from Thaivigibase. • 5 years experience

  9. Methodology • During 2003 to 2007, we carried out a retrospective search in the Thaivigibase of spontaneous adverse drug reaction database. • Reports were included if they had been recorded at least one prescription of carbamazepine from the hospitals and clinics between January 1, 2003 to December 31, 2007.

  10. Methodology • A search of preferred term for potential cases were all reports of skin and appendage disorders. • Information on patient demographic information , medical history, clinical conditions and concomitant drug and sources of reports were collected.

  11. Methodology • Reports were excluded if they had no record of carbamazepine for suspected or concomitant drug during the study period. • Descriptive statistics was calculated. The analysis was performed with chart and cumulative percentage.

  12. Results • A total of 1,132 reports with 1,769 adverse reactions were reported during study period. • Most reports came from general hospitals (25.49%), center hospitals (25.04%) and community hospitals (19.80%).

  13. The percentage of reports categorized by source of report

  14. Results • The age range of reported cases was 3 months to 89 years (median, 44 years). • 693 reports of 1,132 reports (61.21%.) were male. • 19 of 154 reports (12.33%) with allergic history information had carbamazepine associated reaction experience.

  15. Results • 648 reports (57.24%) were serious adverse drug reactions. Almost of them (83.48%) resulted in admitted or prolonged hospitalization. • Two fatal outcome cases were reported due to Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN).

  16. Results • 1,230 of 1,769 events (69.53%) were described as skin reaction • Stevens Johnson syndrome (SJS) was the most frequently reported event (32.85%) • followed by maculo-pupular rash ((13.50%) and rash (11.95%).

  17. Results • Other severe skin reaction including 1.10.55% of erythema multiforme (EM) 2.3.09% of toxic epidermal necrolysis (TEN)

  18. The percentage of skin reactions

  19. Conclusions • Stevens Johnson Syndrome (SJS) was the highest reported adverse drug reactions. • Our findings are consistent with available evidence with the literature reported.

  20. Recommendations • Further analytical study and pharmacogenomic study should be conducted. • HPVC center will collaborate with the genetic section to study the association and further reducing these severe skin reactions

  21. Recommendations • The cost-effectiveness study on gene testing before prescribing carbamazemine is ongoing performed.

  22. Acknowledgements • Networking centers contributing data to the Health Product Vigilance Center. • All staffs at Health Product Vigilance Center, FDA, Thailand.

  23. Thank you for your attention

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