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. InTROduCTIOn
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
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[5] Csonka GW, Rosedale N, Walkden L. Balanitis due to fixed drug
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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
Bilt-ekon organ inform zdrav 2010; (26)3: 1-5hUman enhanCement and health Care: some ethiCal issUes izBoljŠeVanje ^loVeKa in zdraVstVeno VarstVo: neKaj eti^nih VpraŠanj in motenj, hkrati pa lahko iste metode slu`ijo tudi za izbolj{evanje nekaterih lastnosti in zmo`nosti modern biotechnologies make treatment of diseases pri zdravih ljudeh. modafinil je npr. sredstvo za and disorders incr
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