Fixed Drug Eruption - An analysis.

Narmadha Devi, T G (2011) Fixed Drug Eruption - An analysis. Masters thesis, Madras Medical College, Chennai.


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INTRODUCTION : World Health Organisation has defined a drug as “a substance or product that is used or intended to be used to modify or explore physiological system or pathological state of the recipient”. Adverse drug reaction is defined by WHO as “a response to a drug that is noxious, unintended and undesired and occurs at doses used in man for modification of physiological function”. ADRs affect upto 7% of the general population and constitute upto 8% of hospital admissions. Cutaneous ADRs are among the more commonly observed adverse reactions to medications. Among the various morphological drug reaction patterns encountered, Fixed Drug Reactions account for upto one third of cases. According to many Indian studies, Fixed drug eruption is the most common cutaneous adverse drug reaction pattern, constituting 25-40% of cases. In the western world, it is next only to maculopapular rash as the common cause of CADR. Several studies analysing the epidemiological, pathophysiological, pharmacological and clinical aspects of FDE are available in literature. Though clinically less severe, FDE causes cosmetic embarrassment in many patients. AIMS OF THE STUDY : To find out the incidence, age and sex distribution of Fixed Drug Eruption among patients attending the Department of Dermatology, Government General Hospital, Chennai. * To find out the proportion of FDE cases among various cutaneous adverse drug reactions. * To find out the common offending drugs and study the drug specific clinical patterns and sites of involvement in the FDE cases. * To study the different parameters of fixed drug reaction - Number of episodes in a patient and mean length of time from drug exposure to the development of FDE lesions during initial and subsequent episodes. * To confirm the drugs responsible for causation through patch testing. * To study the various histopathological characteristics of fixed drug eruptions. * To ascertain the role of CD8+ T-cells in causation through Immunohistochemistry. CONCLUSION : 1. The incidence of Fixed Drug Eruption among Dermatology OPD attendees from Aug 2008 to Aug 2010 was found to be 0.54%. 2. The main age group affected was 21 – 30 years. 3. An almost equal sex incidence. was observed with the male to female ratio being 1.23:1. 4. The incubation period observed during the first and subsequent episodes was 13.4 days and 4.6hrs respectively. 5. The most common offenders were fluoroquinolones especially ciprofloxacin seen in 14.5% of cases and levofloxacin in 10.5% of cases. The next common offender was cotrimoxazole inducing FDE in 11.8% of cases. Nonsteroidal antiinflammatory drugs were the causative drugs in 19.73% of cases with diclofenac being the main inducer followed by paracetamol. 6. Classical presentation was seen in 81.57% of cases. The other two morphological patterns encountered were Bullous FDE(18.42%) and Nonpigmenting FDE(1.33%). 7. Multifocal pattern was the most common pattern of distribution of lesions. Solitary and generalised patterns were also encountered. 8. Extremities were the most frequently involved sites seen in 44.73% of cases, followed in decreasing order of frequency by trunk, face, oral mucosa, genital mucosa, lips and palms and soles. 9. There was no statistically significant difference between males and females regarding the site of involvement . Clinically mucosal lesions and lesions on the palms and soles were more commonly encountered in males. Involvement of the lip was commonly seen in females. 10. Though statistically insignificant, clinically significant associations were observed regarding drug specific site of involvement. Phenytoin induced FDE exclusively on the trunk. Paracetamol was observed to induce bullous FDE preferentially on palms and soles Ciprofloxacin induced lesions mainly on the extremities. 11. The rate of occurrence of associated local and systemic symptoms was 78.95% and 14.47% respectively which is relatively high when compared to previous studies. 74 12. Drug patch tests done to establish the causality of offending drugs revealed positivity in 32.9% of patients. The testing was found to be positive when done on lesional skin when compared to nonlesional skin. 13. Histopathological examination of biopsy specimens produced consististent findings in all the 33 cases in whom biopsy was performed. 14. Immunohistochemical analysis done using antibodies to CD8 revealed positivity in both acute and chronic cases, establishing the role of these cells in causation of FDE. In the current study, the number of patients observed was less when compared to the previous studies. So statistical analysis did not reveal any significance regarding the sex specific and drug specific site of involvement.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Fixed Drug Eruption ; An analysis.
Subjects: MEDICAL > Dermatology Venereology Leprosy.
Depositing User: Subramani R
Date Deposited: 05 Jul 2017 06:11
Last Modified: 05 Jul 2017 09:19

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