Causality, Severity and Preventability Assessment of Adverse Cutaneous Drug Reaction: A Prospective Observational Study in a Tertiary Care Hospital

Padmavathi, S; Manimekalai, K; Ambujam, S

doi:10.7860/jcdr/2013/7430.3753

Cited by 17 publications

(14 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Offending drug was not recognized by Lee [ 4 ] and Lee et al [ 10 ] in 71.6% and 23% of patients, respectively. Concurrent intake of multiple drugs [ 10 , 16 ], multiple FDE [ 17 ], controversial usefulness of patch test [ 18 ], self-medication, and inaccurate past medical history reported by the patients [ 19 ] are the most important impediments for determination of culprit drugs.…”

Section: Discussionmentioning

confidence: 99%

“…In most studies, multifocal or generalized FDE is not common [ 4 , 10 , 16 ], and bullous type of GFDE is its rare form, which must be differentiated from Stevens-Johnson syndrome and toxic epidermal necrolysis [ 7 , 10 ]. Repeated intake of causative drug or related drugs, in addition to old lesions, induces new lesions which occasionally become generalized [ 1 , 19 ]. We think dissemination in most of our cases may be associated with atypical presentation, unawareness of FDE on the part of general practitioners, self-medication, and confusing history reported by the patients, which resulted in delay in diagnosis and avoidance of culprit drug.…”

Section: Discussionmentioning

confidence: 99%

“…In a case series by Patro et al [ 16 ] and another study by Lee et al [ 10 ], recognition of incremental drug was not possible in most of the patients with multifocal FDE or GFDE because of multiple drug intake. The difference of causative drugs in various areas may be dependent on self-medication in the community [ 20 ], genetic predisposition [ 23 ], concurrent intake of multiple drugs [ 16 ], and popular drugs in each region [ 19 ].…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Clinical Features and Drug Characteristics of Patients with Generalized Fixed Drug Eruption in the West of Iran (2005–2014)

Kavoussi

Rezaei

Derakhshandeh

et al. 2015

Dermatology Research and Practice

View full text Add to dashboard Cite

Background. Generalized fixed drug eruption is a specific variant of fixed drug eruption with multifocal lesions. Diagnosis of this drug reaction is straightforward, but occasionally recognition of the causative drug is not possible. This study was aimed at evaluating the clinical features and culprit drugs in generalized fixed drug eruptions in the west of Iran. Method. This cross-sectional study was carried out on 30 patients with criteria of generalized fixed drug eruption over 9 years. Demographic, clinical, and drug intake information were collected. Results. Out of 30 patients (17 females and 13 males) with the mean age of 26.67 ± 10.21 years, 28 (93.3%) and 2 (6.7%) cases had plaque and bullous clinical presentation, respectively. Upper limbs were the most common (90%) site of involvement. The antibiotic group, especially cotrimoxazole (26.1%), was reported to be the most common offending drug, but the causative drug was not determined in 7 (23.3%) patients. Conclusion. Many cases of generalized fixed drug eruption firstly presented as limited lesions and led to generalized lesion due to repeated intake of the causative drug. No causative drug was found in some patients, which might be associated with concurrent intake of several drugs, multiple FDE, and peculiarity of the patch test.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Clinical Features and Drug Characteristics of Patients with Generalized Fixed Drug Eruption in the West of Iran (2005–2014)

Kavoussi

Rezaei

Derakhshandeh

et al. 2015

Dermatology Research and Practice

View full text Add to dashboard Cite

show abstract

“…This serves as useful reference to alert clinicians to the likelihood of a particular drug causing a suspected reaction. To assess the level of severity of reported ADRs Hartwig's scale was used, which revealed that moderate cases were 26(52%), mild cases were 17(34%) and 7(14%) of severe cases, which is similar to a study conducted by Padmavathi S et al 9 Most of the patients on multiple drug therapy developed more number of moderate level severity reaction than others. Drug stopped 27(54%) was the foremost line of management of ADRs while supplement added were 13(26%), drug replaced 12(24%), dose altered 2(4%) and no change was made with the suspected drug in 2(4%).…”

Section: Discussionmentioning

confidence: 67%

Pharmacist Mediated Assessment and Reporting of Adverse Drug Reactions in a Tertiary Care Hospital

Zia¹,

Pradeepthi²,

Ashwini³

et al. 2018

IJOPP

View full text Add to dashboard Cite

Background: ADRs are one of the foremost reasons of illness and death, adding to overall preventive medicine cost. Reporting of such adverse drug reactions are critical parameter of medical treatment. The present study assess the clinical pharmacist role in drug monitoring to detect and intercept adverse drug reaction in a health care setting, Method: A prospective observational was conducted at tertiary care hospital in Vijaypur city. A total of 50 suspected adverse effects were recognized and documented during the study period of six months. The suspected adverse effects were assessed for its causality and severity by using Naranjo's and Hartwig's scale. Results: Overall 50 ADRs were identified and documented during the study period. Most of the reported ADRs in this study were Type A 34(68%). Drug dose and frequency 18(33.96%), Age 15(28.3%) and polypharmacy 10 (18.86%) were the furthermost protruding predisposing factors of ADRs were observed. Antibiotics were the common class of drugs involved in producing ADRs 14(28%).Causality assessment by Naranjo's scale presented that majority of the reported ADRs were found to be probable 26(52%), possible 19(38%) and definite 3 (6%). Severity assessment by Hartwig's scale showed that 26(52%) ADRs were moderate, 17 (34%) ADRs were mild and 7(14%) ADRs were of severe. Withdrawal of the drug 27(54%) as a management intervention was the core line of the adverse drug effect management. Conclusion: Clinical Pharmacist preparedness towards pharmacovigilance approach and proximity for drug monitoring resulted in greater interception and reporting of adverse effect ensuring patient drug related safety.

show abstract

“…Recent studies from India suggest that fixed drug eruptions (FDEs) account for 20–43% of all cutaneous adverse drug reaction (CADR) patterns. [ 1 2 ] Exact pathogenesis remains obscure but intraepidermal CD8 + T cells that persist at the previous injury site mediate and are directly implicated in the epidermal injury causing localized cutaneous changes. [ 3 ] FDE has multiple variants, including generalized, linear, bullous, urticarial, pigmenting, nonpigmenting, wandering, eczematous, psoriasiform, erythema dyschromicum perstans like, vulvitis and oral FDE.…”

Section: Introductionmentioning

confidence: 99%

Bullous fixed drug eruption probably induced by paracetamol

Mukhopadhyay

et al. 2016

Indian J Dermatol

View full text Add to dashboard Cite

We report a case of a 42-year-old male who presented with second episode of bullous eruptions after ingestion of paracetamol. There were no systemic complaints. The temporal correlation with the drug, history of a similar episode and the quick improvement led us to a diagnosis of bullous fixed drug due to paracetamol. Applying Naranjo's algorithm, a causality score of 8 was obtained and was categorized as probable reaction to paracetamol. Clinicians should be vigilant of the possible adverse reactions to drugs with robust safety profiles. Drug alert cards could play an important role in preventing recurrences.

show abstract

Causality, Severity and Preventability Assessment of Adverse Cutaneous Drug Reaction: A Prospective Observational Study in a Tertiary Care Hospital

Cited by 17 publications

References 5 publications

Clinical Features and Drug Characteristics of Patients with Generalized Fixed Drug Eruption in the West of Iran (2005–2014)

Clinical Features and Drug Characteristics of Patients with Generalized Fixed Drug Eruption in the West of Iran (2005–2014)

Pharmacist Mediated Assessment and Reporting of Adverse Drug Reactions in a Tertiary Care Hospital

Bullous fixed drug eruption probably induced by paracetamol

Contact Info

Product

Resources

About