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Original Article
A Study on Genital Fixed Drug Eruption in a Tertiary Care Hospital Sanjay Kumar Kanodia, amoolya K. Seth, Shailja ratan ShuKla ABSTRACT
erythema at or around the existing lesion was considered as Background: Genital fixed drug eruption (FDE) present as single
oval lesion, most commonly over glans penis and are many Results: Thirty eight cases (35 males and 3 females) were
times wrongly diagnosed and treated as sexually transmitted enrolled in the study with clinical diagnosis of FDE. The lesions were most commonly present on the glans penis (68.42%) as Objectives: The aim of this study was to present a series of
hyperpigmented macule (47.36%) accompanied with pruritus cases of genital lesions with fixed drug eruptions, diagnose (71.05%), burning (55.26%) and pain sensation (28.94%). the suspected drug and identify the change in pattern of drugs Oral rechallenge test showed positive result in 29 cases with nimesulide (35.29%) as the most common offending drug Methods and Material: Patients with the genital FDE were
followed by fluconazole (25.52%) and tetracycline (14.70%).
interviewed for onset and duration the disease with history of Conclusion: The study emphasizes the changing trend of genital
all drugs taken and a list of suspected drugs was made for FDE and the importance of oral provocation test for diagnosing each patient. Rechallenge test (oral provocation test) was done genital fixed drug eruptions. The findings in this study is in for the suspected drug with a quarter of a single therapeutic contrast to the previous studies which showed antimicrobials dose, followed if necessary, by a step-wise increase to one half, (tetracyclines) as the commonest cause of genital FDE’s.
one full and double of a dose for subsequent days. A definite Key Words: Fixed drug eruptions(FDE), Genital lesions, Oral rechallenge test (oral provocation test), Nimesulide KeY MeSSAGe
With the changing trend, time and availability, nimesulide is emerging as common cause of genital FDEs.
and interrogated regarding the onset and the duration of the Genital lesions of any kind are a cause of confusion to the disease. They were also asked about the history of all the drugs dermatologists, because of their varying possible causes. Genital which they had taken. A list of suspected drugs was made for each fixed drug eruption (FDE) in particular, is the cause for apprehen- patient on the basis of their detailed history. Systemic examination sion in the sufferer. These appear as oval, erythematous macules and routine blood examination along with liver and renal function and recur at the same areas following every administration of the tests were done for each patient. Sexually transmitted diseases responsible drug [1].The patients are often unaware of the nature were ruled out by the clinical examination and the relevant lab- of the drugs which are consumed by them and do not relate their The rechallenge test (oral provocation test) was done for the sus- The incidence of FDE induced by a specific drug depends on the pected drug after taking a written consent from the patients. It frequency of the agent which is used in a given part of the world [2]. was started with a quarter of a single therapeutic dose, followed if Although a large number of drugs have been incriminated to cause necessary, by a step-wise increase to one half, one full and double FDE, certain drugs have been found to be responsible more often. of a dose for subsequent days. A definite erythema at or around The aim of this study was to identify the agents which commonly the existing lesion indicated a positive provocation test. The drugs caused genital FDE in the patients of a tertiary care hospital in the which were used for the provocation test included nimesulide, ampicillin, teracycline, fluconazole, cotrimoxazole and aspirin as per the history of the suspected drugs for FDE. The rechallenge MATeRIAl And MeThOdS
was considered to be negative if exacerba tion of the lesion was not This study was done from February 2009 to March 2011 after seen within 24 hours, even after the administration of the double obtaining ethical approval from the institution where it was done. dose. Biopsies were not done at the genital site in any of the cases Patients with the clinical diagnosis of genital FDE were enrolled because of ethical and medical reasons.
Journal of Clinical and Diagnostic Research. 2011 August, Vol-5(3): 700-702 Sanjay Kumar Kanodia et al., Genital fixed drug eruption in a tertiary care hospital dISCuSSIOn
A total of thirty eight patients (35 males and 3females) with genital The observations of the present study implicated nimesulide as the FDE, in the age group of 13 to 56 years (mean age = 27.5 years), most common agent which caused genital FDE, which differed from visited the dermatology outpatients department. The duration of the findings of other studies. In earlier studies, antimicrobials were the lesions varied from 2 days to 3 years. A maximum number of the most commonly implicated drugs for FDE, with tetracycline on patients had lesions on the glans penis (68.42%). Hyperpigmented the top of the list in the three series [2-5]. In studies on genital FDE in macular lesions were present in 18 patients (60.52%). The most the premillenium era, tetracycline was the widely used drug. In the common symptoms which were presented by most of the patients context of NSAIDs also, acetyl salicylic acid and phenylbutazone were pruritus (71.05%), followed by a burning sensation (55.26%).
were found to be the most common offending agents in these studies. Out of the 38 cases, the rechallenge test was positive in 34 patients with various doses of drugs as shown in Table 2. The onset of the Nimesulide is a nonsteroidal, anti-inflammatory agent with anti- lesion was noticed as early as 3 hours to a maximum of 23 hours pyretic and analgesic properties, which is commonly prescribed (mean=8.5hours) after the administration of the drug. Nimesulide in India [6].The dermatological side effects which were previously was the most common offending agent, affecting 12 patients reported with respect to its use were pruritus, urticaria, purpura, (35.29%), followed by fluconazole in 8(25.52%) and tetracycline in maculopapular rash and localized toxic pustuloderma [7, 8].There 5 patients (14.70%). The test was positive for half the drug dose are only a limited number of studies on FDE which are the secondary in 18 cases, followed by positivity for a full dose in 9 and positivity effects of nimesulide [9,10]. To the best of our knowledge, there is for a 1/4th dose of the drug in 6 cases. We considered the drug no previously reported study which has expressed nimesulide as to be responsible for FDE only, in cases where the rechallenge test was positive. The blood and systemic examination showed no With the changing times, the trend of drug use also changes. The abnormality in all the patients, except for one case where the liver increasing use of nimesulide and fluconazole, with the over- the- function test results were marginally high [Table/Fig-1 & 2].
counter availability of these drugs in the Indian market, could be one of the reasons for the increased reporting of their adverse effects. The under reporting of the side effects of nimesulide in the western literature may be possibly due to its non-availability in This study also emphasizes the importance of the rechallenge test (oral provocation test) for pin pointing the diagnosis of fixed drug Key Words: Fixed drug eruptions(FDE), Genital lesions, Oral rechallenge test (oral provocation test), Nimesulide eruptions, specifically so in genital cases where a biopsy is not possible due to the chances of scarring and for ethical reasons. The provocation testing is both safe and reliable and it must be done to confirm the cause of the fixed drug eruptions [11]. The administration of graded doses is a rational approach so as to elicit the signs of reactivation at the minimum dose [12]. It is interesting to note that in our study, only three females re- ported with genital FDE, who were referred by gynaecologists for ruling out venereal diseases. This can be explained on the basis of the stigma and embarrassment due to genital problems in females, because of which they probably do not report to dermatology As FDE are sometimes confused with multiple venereal diseases, it is of utmost importance for all the medical specialists to study the entity of and to identify genital FDE clinically and by doing the [Table/Fig-1]: Characteristic features in patients with fixed drug eruptions
provocation test so that these cases are not missed.
[Table/Fig-2]: Results of Rechallenge test with suspected drugs in patients with fixed drug eruptions
*Out of total 38 cases, 34 cases showed positive result and 4 cases negative result to rechallenge test.
Journal of Clinical and Diagnostic Research. 2011 Aug, Vol-5(4): 700-702 Sanjay Kumar Kanodia et al., Genital fixed drug eruption in a tertiary care hospital ReFeRenCeS
[8] Lateo S, Boffa MJ. Localised toxic pustuloderma which is associated [1] Baker H. Fixed eruptions. Text Book of Dermatology, Third ed, Editors, with nimesulide therapy and confirmed by patch testing. Br J Dermatol. Blackwell Scientific Publications, Oxford. 1979; p 1121-22. [2] Pasricha JS. Drugs causing fixed eruptions. Br J Dermatol. [9] Corderio MR, Gonacalo M, Fernandes B, Oliveira H, Figuedo A. Positive lesional patch tests in fixed drug eruptions from nimesulide. [3] Sehgal VH, Gangwani OP. Genital fixed drug eruptions. Genitourin [10] Valsecchi R , Reseghetti A, Cainelli T. Bullous and erosive stomatitis [4] Pandhi RK, Kumar AS, Satish DA, Bhutani LK. Fixed drug eruptions which is induced by nimesulide. Dermatology. 1992;185:74-5.
on male genitalia: a clinical and etiological study. Sexually transmitted [11] Baer RL, Witten VN. Drug eruptions. A review on the selected aspects of an age-old but always timely and fascinating subject. In: Yearbook of [5] Csonka GW, Rosedale N, Walkden L. Balanitis due to fixed drug dermatology series 1960-61. Chicago: Yearbook Medical Publishers, eruptions which are associated with tetracycline therapy. Brit J Vener [12] Kauppinen K. Cutaneous reactions to drugs, with special reference to [6] Malhotra S, Pandhi P. Analgesics for pediatric use. Indian J Pediatics. severe bullous muco-cutaneous eruptions and sulphonamides. Acta Derm Venereol [Suppl] (Stockh) 1972;52:68.
[7] Kanwar AJ, Kaur S, Thami GP. Nimesulide induced purpura. name, addreSS, telePhone, e-mail id oF the C-90, Sethi Colony, Jaipur-302004Phone numbers-09928977411 1. Asst.Professor, Department of Dermatology, Venereology and Leprosy, National Institute of Medical Science & Research, Nims University, Jaipur-303121.
2. Associate Professor, Department of Psychiatry, National Institute of Medical Science & Research, Nims University, Jaipur-303121.
3. Professor & Head, Department of Dermatology, Venereology and Leprosy, National Institute of Medical Science & Research, Nims University, Jaipur-303121.
Journal of Clinical and Diagnostic Research. 2011 August, Vol-5(4): 700-702


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