English abstract
Introduction: Cutaneous adverse drug reactions (CADR) from all
regions of Oman are monitored by spontaneous adverse reaction
reporting and monitoring system.
Methods: A total of 100 patients with cutaneous adverse drug
reactions were analyzed in a cohort study for 15 months from 1st
June 2005 to 31st August 2006.
Results: Out of 100, 85 cases were reported in one year time;
from 1st of June 2005 to 31st of May 2006, where 80 were Omani
patients and 5 expatriates. Therefore, the incidence was found to be
36 cases per million of total population of Oman (85/ 2,340,815),
and 45 per million of Omani population (80/ 1,781,558) for that
period. CADR patients comprised 8.5% of the total admitted
patients in the skin ward at Al-Nahda Hospital; a tertiary
dermatology center. While incidence of CADR among outpatients
attending dermatology clinics in Al-Nahda hospital was found to
be only 0.3%. Under reporting was the main reason behind this
low incidence. However, relatively higher incidence was reported
in cases of Toxic Epidermolytic Necrosis (TEN); 2 per million.
The clinical patterns and the drugs causing CADR are remarkably
similar to those observed in other countries except for minor
variations. Urticaria followed by Fixed Drug Eruptions (FDE)
and Maculopapular Eruptions (MPE) were the most common
reactions. Based on WHO definition of severe ADR; 21% of the
cases were classified as severe reactions. One death reported a case
of TEN due to Intramuscular Diclofenac. Non-steroidal,antiinflammatory drugs (NSAIDs) and the antimicrobial agents
were the most frequent offending drugs. Most cases of TEN were
caused by injection Diclofenac, where most of FDE were caused
by NSAIDs.
Conclusion: Based on these results; it was recommended in
a circular no. 44/2007/47 from the Director General of the
Directorate of Drug Control to restrict the use of Diclofenac
Injection
