ABSTRACT
Paracetamol is a commonly used antipyretic and analgesic with a weak anti-inflammatory action with a good safety profile in children and adults. This has resulted in its over prescription and large over the counter sale. Thus, adverse drug reactions due to paracetamol may be easily overlooked resulting in delay in diagnosis. Author present a case report of a 12 year old boy with bullous fixed drug eruptions due to paracetamol while he tolerated NSAIDS well. This highlights the need of adverse drug reaction monitoring and reporting, for early detection and prompt treatment of drug related morbidity and the cautious use of even the most commonly used drugs.
ABSTRACT
Fixed drug eruption (FDE) is a most commonly with adverse drug reaction seen with use of Non-steroidalanti-inflammatory drugs (NSAIDs) in particular nimesulide followed by antibiotics and anticonvulsants. Etoricoxib is a selective cyclo-oxygenase isoenzyme-2 inhibitor which is superior to conventional NSAIDs and causes less side effects. Authors present a case of fixed drug eruption due to etoricoxib in a male patient. A 50-year-old patient presented to Outpatient Department (OPD) of Dermatology of a Tertiary Care Hospital with complains of skin rashes over lips, oral cavity, trunk, both the upper and lower limbs, palm, soles, scrotum and glans penis since a week. The detailed history of the patient revealed the use of etoricoxib a week back, prescribed for low back pain. It was suspected that the cutaneous drug reaction was due to the use of etoricoxib. The suspected drug etoricoxib was stopped, patient was admitted and managed symptomatically. The above reaction was assessed to be “possible” as per WHO-UMC and Naranjo causality scale, “moderate” on Hartwig’s scale and “Probably preventable” according to Schumock and Thornton criteria. This case reporting was done to sensitize the prescribers regarding rare side effects of the above drug and the need to confirm past history of drug reaction before prescription.
ABSTRACT
Background: Various studies have found the overall incidence of cutaneous adverse drug reactions (CADR’s) in developed countries as 1-3%, while the incidence in developing countries is thought to be higher between 2 and 5%. FDEs’ share is seen to be about 15 -30% of all CADR’s as reported in various studies. Aim of the research work was to study the clinical and epidemiological features of fixed drug eruptions and to identify probable culprit drug or drugs using Naranjo ADR probability scale and to provide information to the patient regarding the drug responsible for his/her drug rash.Methods: A total of 180 patients of fixed drug eruptions were taken up for study who presented to skin OPD at a tertiary centre of North India. Diagnosis was made on the basis of history of drug intake prior to drug eruption, repetition of similar lesions on same as well as new sites on intake of same drug with improvement of skin lesions on discontinuation of the causative drug. Further on examination, skin lesions with typical morphology compatible with FDE were seen. Causality of the FDE was assessed according to the NARANJO ADR probability scale.Results: A total of 180 patients of FDE were studied. Males outnumbered the females. The most common class of drug implicated was antimicrobials seen in 115 patients followed by NSAIDS 65 patients. Regarding the clinical presentation both skin and mucosal involvement was seen. The most common skin lesions were erythematous to hyperpigmented and violaceous macules followed by bullous FDE.Conclusions: In summary, early recognition of FDE is important not only for the dermatologists but also for the clinicians of other specialties, so that the culprit drug is recognized and stopped immediately. Drug reactions are a common reason for litigation and has medicolegal pitfalls.
ABSTRACT
Fixed drug eruptions (FDEs) may account for 16-21% of all cutaneous drug eruptions. Recent research suggests a cell-mediated process that initiates both the active and quiescent lesions. The major categories of causative agents of fixed drug eruption include antibiotics, antiepileptics, nonsteroidal anti-inflammatory agents, sildenafil, and phenothiazines, although numerous other agents and certain foods such as cashews and licorice have also been reported as causative agents. A 38 year old male presented to the dermatology OPD with hyperpigmented and erythematous macular eruptions on the neck, chest, right arm, left scapular region, left wrist and left knee. The eruptions were associated with burning sensation and itching. He informed having taken medications for gastroenteritis the night before. The medications were Ofloxacin and Ornidazole (FDC), Omeprazole and Domperidone (FDC) and Paracetamol. He gave a history of a similar event, a year ago, with the same antimicrobial combination (Ofloxacin and Ornidazole), although the macular eruptions were restricted to the neck, arm and knee with bleb formation and severe burning sensation. Since the macular eruptions reoccurred, although with extra regions being affected, a diagnosis of FDEs was made. The most probable cause for these FDEs seems to be FDC of Ofloxacin and Ornidazole, because the patient gives history of taking Omeprazole and Paracetamol before without any FDEs. According to Naranjo’s Adverse Drug Reaction Probability Scale, the FDC of Ofloxacin and Ornidazole is a definite cause for the FDEs. (Score = 9).
ABSTRACT
Background: Although extensively studied in adults, Nonsteroidal anti-inflammatory drug (NSAID) hypersensitivity in children, especially in young children, remains a poorly defined area in both its clinical and epidemiologic aspects. Methods: The present observational study was conducted in the department of Dermatology of a tertiary care hospital in Eastern India. Twenty children (20) were screened with suspected NSAID-associated fixed drug eruption (FDE) in the outpatient department. A thorough history taking and clinical examination was performed for each of the cases of FDE. These cases were then managed conservatively after discontinuation of the suspected medication. Rechallenge with the putative offending drug was not done due to ethical reasons. WHO-UMC Causality Assessment criteria and Naranjo probability scale were used for causality assessment of each of the cases of FDE. The severity of reported reactions was assessed by using Modified Hartwig and Siegel Scale and Preventability of the ADRs was assessed by Modified Schumock and Thornton Scale. Results: Patients aged between 5 to 12 years and with a male preponderance of 3:2. The offending NSAID was ibuprofen for 8 of the patients, paracetamol and diclofenac for 4 each and ketorolac for 4 of the patients. These patients were prescribed the offending drugs for fever, rheumatoid arthritis and minor trauma. For each patient, history and clinical signs was consistent with the diagnosis of drug-induced FDEs. Causality assessment for each of the cases revealed ‘possible’ association predominantly (80%). Severity of the suspected ADR (adverse drug reaction) assessed using Modified Hartwig and Siegel Scale, revealed that the ADRs were mild(30%) to moderate (70%) in severity and of ‘probable’ preventibility (90%). Conclusions: 20 new cases of NSAID-induced FDEs over a period of 6 months suggest that this is not a rare entity as was presumed. There is a growing need for a strict monitoring of such off label offending drugs, known to cause ADRs especially among pediatric patients to ensure safe and rational therapeutics.
ABSTRACT
A fixed drug eruption (FDE) is a distinct drug induced reaction pattern that characteristically recurs at the same site on the skin or mucosa. We report a case of bullous FDE following ingestion of cetirizine, a common treatment for allergic disorders but a rare causative agent for cutaneous adverse drug reaction.
ABSTRACT
The reasons of same site recurrence in fixed drug eruptions (FDEs) remain to be clarified. Although the nature of antigen in FDE is unknown, drug metabolites could play a role for antigen formation. Cytochrome p450 isozymes (CYPs) are important enzymes for drug metabolism. This study was done to examine the role of CYPs in FDEs. Provoked lesion was compared with non-provoked lesion by the same drug on the same patient to overcome inter-individual variations of CYPs. The reverse transcriptase-polymerase chain reaction (RT-PCR) with primers for CYPs and the immunohistochemistry (IHC) with anti-CYPs, pancytokeratin, and leukocyte common antigen (LCA) antibodies were conducted. The causative drugs were different in 13 patients who conducted RT-PCR, and the result could not be analyzed by the cause. The levels of CYP2C8/19 and CYP2E1 mRNAs increased significantly in provoked lesions. The keratinocytes in cases of mefenamic acid-induced FDEs stained strongly with anti-CYP2C9 antibody not with the other three antibodies (CYP1A1, CYP2E1, and CYP3A4). The FDE cases from doxycycline, which is not metabolized by CYP2C9 enzyme, and those from chlormezanone did not react to anti-CYP2C9 antibody. The cells stained with CYP antibodies did not react with anti-LCA antibody but with anti-pancytokeratin antibody. The number of cells which reacted to anti-LCA antibody clearly increased in the provoked lesions, regardless of the cause. The above results suggest that CYPs may contribute the drug antigen formation and different levels of CYPs between provoked and non-provoked lesions can play a role for the same site recurrence of lesions in FDEs.