Fixed drug eruption (FDE) is a type of drug-induced skin reaction pattern that characteristically recurs at the same skin or mucosal site. Paracetamol is one of the common drugs prescribed as analgesic–antipyretic agent in all age group of patients. FDE is a well-reported, but uncommon side-effect of paracetamol, usually the classic, pigmenting type most commonly found in children and adolescents. We present a case of 52 years old male patient who developed FDE over the glans penis following paracetamol use

Dakhale, Ganesh N.

Hire, Rohan C.

Kale, A. S.

Kamble, Amruta

Sontakke, Smita

English

International Journal of Basic & Clinical Pharmacology

Print ISSN 2319-2003 | Online ISSN 2279-0780doi: 10.5455/2319-2003.ijbcp20140429IJBCP International Journal of Basic & Clinical Pharmacologywww.ijbcp.com International Journal of Basic & Clinical Pharmacology | March-April 2014 | Vol 3 | Issue 2 Page 399Case ReportParacetamol induced fi xed drug eruption: a case reportRohan C. Hire, Smita Sontakke, Ganesh N. Dakhale*, Amruta Kamble, A. S. KaleINTRODUCTIONFixed drug eruption (FDE) is a cutaneous adverse drug reaction commonly seen in children and adolescents that is frequently misdiagnosed, leading to recurrent eruptions when the offending drug is readministered.1 The diagnostic hallmark is its recurrence at previously affected sites. Paracetamol is a readily available over the counter (OTC)antipyretic. Despite its widespread use, adverse reactions are unusual at therapeutic dose. Its cutaneous adverse effects are rare, varying from transient pruritis or maculopapular rash to Stevens-Johnson syndrome and even fatal toxic epidermal necrolysis.2 FDE to paracetamol is well-reported in children and adolescents but is rare in elderly and very few reports are available.2,3 Here, we describe a case of 52 years old male patient who developed FDE over the glans penis following paracetamol use.CASE REPORTA 52 years old male patient was brought with a history of erythematous rash that started on back and gradually became generalized all over the body sparing palms, soles, and mucosal surfaces over a period of 5 days. Rashes were well-circumscribed, 5-7 cm in size with a burning sensation without itching and blebs or pustules formation. These rashes were associated with intermittent moderate grade fever without chills and rigors. There was no history of similar complaints in the past. Hence, the provisional diagnosis of generalized erythematous rash of allergic origin was made. After admission, patient was given tablet paracetamol 500 mg three times a day, tablet prednisolone 10 mg twice a day and tablet chlorpheniramine maleate 25 mg twice a day. This oral treatment was also supplemented with intravenous fl uids. The same day, late in the evening patient accidently noticed erythematous, macular, multiple lesions with size varying between 1 and 2 mm over the glans penis after retracting the prepuce. There was no itching, scaling or burning over the glans. Immediately, withdrawal of paracetamol was initiated suspecting it to be the causative agent. Thereafter, erythema associated with the lesions over the glans started subsiding over next 2 days. On the 3rd day after withdrawal of tablet paracetamol, erythematous lesions over the glans completely evolved into hyperpigmented lesions in the phase of recovery. The probability of FDE due to paracetamol cannot be ruled out after applying Naranjo’s ABSTRACTFixed drug eruption (FDE) is a type of drug-induced skin reaction pattern that characteristically recurs at the same skin or mucosal site. Paracetamol is one of the common drugs prescribed as analgesic–antipyretic agent in all age group of patients. FDE is a well-reported, but uncommon side-effect of paracetamol, usually the classic, pigmenting type most commonly found in children and adolescents. We present a case of 52 years old male patient who developed FDE over the glans penis following paracetamol use.Keywords: Skin eruptions, AcetaminophenDepartment of Pharmacology, Government Medical College, Nagpur - 440 003, Maharashtra, IndiaReceived: 27 December 2013Accepted: 02 February 2014*Correspondence to:Dr. Ganesh N. Dakhale,Email: gndakhle@rediffmail.com© 2014 Hire RC et al. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.Hire RC et al. Int J Basic Clin Pharmacol. 2014 Apr;3(2):399-400 International Journal of Basic & Clinical Pharmacology | March-April 2014 | Vol 3 | Issue 2 Page 400doi: 10.5455/2319-2003.ijbcp20140429Cite this article as: Hire RC, Sontakke S, Dakhale GN, Kamble A, Kale AS. Paracetamol induced fi xed drug eruption: a case report. Int J Basic Clin Pharmacol 2014;3:2:399-400.scale of causality assessment of adverse drug reactions with a score of six. Laboratory investigations such as hemoglobin, complete blood count, and blood sugar level were found to be within normal limits. Rest of the treatment was continued and the initial symptoms improved over next 5 days.DISCUSSIONDrug eruptions have been found to contribute to 5-7% among all type of cutaneous drug reactions.4,5 FDE is a cutaneous type of hypersensitivity reaction to drugs. Paracetamol-induced FDE is reported in literature in less than 1.5% of all cases of FDEs.2 FDE is a hypersensitivity reaction mediated by T cells recognizing haptenated drug antigens presented by epidermal cells. It was recently shown that the most probable effecter cells in established FDE are cytotoxic CD8-positive T cells with natural killer cell-associated molecules resembling effecter cells found in toxic epidermal necrolysis. In fully evolved FDE that eventually resolves, high numbers of intraepidermal suppressor CD4+, CD25+, Foxp3+ regulatory T cells counteract the cytotoxic cells and ameliorate the damage.6FDEs are sharply marginated, round, erythematous to violaceous, 2-10 cm plaques occurring after ingestion of the drug. The lesions usually fl are within 30 min to 8 hrs after drug intake; mean length of time from drug intake to the onset of symptoms is approximately 2 hrs.7 The acute infl ammation disappears within a few days, leaving circumscribed hyperpigmentation for months or even years.8 FDEs characteristically recur in the same location after repeated ingestion of the drug. The antimicrobial drug combination trimethoprim-sulfamethoxazole has been reported as the most common cause of FDE.7,9 Other causes include antimicrobials such as tetracyclines, erythromycin, tinidazole, ampicillin, griseofulvin, clindamycin, albendazole, non-steroidal anti-infl ammatory drugs agents such as aspirin, ibuprofen, diclofenac sodium, piroxicam, paracetamol1 and other drugs like barbiturates.10There are previous reports establishing FDE producing potential of paracetamol.6,8,11 However in this case, the patient suffered from FDE due to paracetamol for the fi rst time in his life though there was history of taking paracetamol many times earlier without any such occurrence. We tried to fi nd out the cause of this new onset FDE to paracetamol even though patient had received it many times in the past. Is this due to the concomitantly administered drug (pheniramine maleate, prednisolone)? We extensively searched the literature about the drug interactions among these three but couldn’t fi nd any satisfactory explanation for this. It is probably the gradual accumulation of memory T cells over a certain period responsible for such new onset FDEs occurring for the fi rst time even though there was history of drug exposure many times in the past.To conclude, in countries where many drugs are available OTC which can produce serious as well as non-serious adverse reactions, it becomes very diffi cult to identify the exact etiological agent when such a reaction occurs. Even previous history of uneventful administration of any commonly used OTC drug does not make it safe for future unadvised administration.Funding: No funding sourcesConfl ict of interest: None declaredEthical approval: Not requiredREFERENCES1. Nino M, Francia MG, Costa C, Scalvenzi M. Bullous fi xed drug eruption induced by paracetamol: report of a pediatric case. Case Rep Dermatol. 2009;1(1):56-9.2. Fathallah N, Salem CB, Slim R, Boussofara L, Ghariani N, Bouraoui K. Acetaminophen-induced cellulitis-like fi xed drug eruption. Indian J Dermatol. 2011;56(2):206-8.3. Drummond C, Fischer G. Vulval fi xed drug eruption due to paracetamol. Australas J Dermatol. 2009;50:118-20.4. Bigby M. Rates of cutaneous reactions to drugs. Arch Dermatol. 2001;137(6):765-70.5. Lee AY. Fixed drug eruptions. Incidence, recognition, and avoidance. Am J Clin Dermatol. 2000;1(5):277-85.6. Bremec T, Demsar J, Luzar B, Adamic M, Pavlovic MD. Longstanding truncal hyperpigmented patches in a young man. Clin Exp Dermatol. 2010;35:e56-7.7. Shiohara T. Fixed drug eruption: pathogenesis and diagnostic tests. Curr Opin Allergy Clin Immunol. 2009;9:316-21.8. Silva A, Proenc EA, Carvalho C, Senra V, Orosario CA. Fixed drug eruption induced by paracetamol. Paediatr Dermatol. 2001;18(2):163-64.9. Bayazit EO, Bayazit H, Ozarmagan G. Drug related clinical pattern in fi xed drug eruption. Eur J Dermatol. 2000;10(4):288-91.10. Savin JA. Current causes of fi xed drug eruptions. Br J Dermatol. 1970;83(5):546-9.11. Mahboob A, Saeed T. Drugs causing fi xed eruptions: a study of 450 cases. Int J Dermatol. 1998;37(11):833-8.

Paracetamol induced fixed drug eruption: a case report

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Paracetamol induced fixed drug eruption: a case report

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