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Cutaneous Adverse Drug Reactions in a Tertiary Teaching Hospital: A Prospective, Observational Study
Anuja Jadhav1, Sharmila Patil2, Isheeta Manchanda2
1Consultant Dermatologist, Dermastudio Skincare and Aesthetic Clinic, Mumbai, Maharashtra, India.
Indian Journal of Dermatology
|January 24, 2022
Summary
Fixed drug eruption is the most common skin reaction to drugs, often linked to antibiotics. Most reactions were deemed probably caused by the medication, based on causality assessment.
Area of Science:
- Dermatology
- Pharmacovigilance
- Clinical Medicine
Background:
- Cutaneous adverse drug reactions (cADRs) are common and can manifest in various clinical patterns.
- Identifying causative drugs and assessing causality are crucial for patient safety and effective management.
Purpose of the Study:
- To describe the clinical presentations of cADRs.
- To identify drugs commonly associated with cADRs.
- To assess the causality of cADRs using the Naranjo scale.
Main Methods:
- Prospective, observational study including patients with suspected cADRs at a tertiary hospital.
- Exclusion of viral exanthemas.
- Documentation of reaction patterns, associated drugs, and causality assessment using the Naranjo scale.
Main Results:
- Sixty-five patients were included, with skin lesions appearing after a median of 2 days.
- Fixed drug eruption (33.8%) was the most common pattern, followed by pigmentation (20%) and maculo-papular rashes (18.5%).
- Antibacterial agents (49.2%) were most frequently implicated, followed by nonsteroidal anti-inflammatory drugs (21.5%) and beta-lactam antibiotics (18.5%).
- The majority of cADRs (87.7%) were assessed as having a "probable" association with the drug.
Conclusions:
- Fixed drug eruption is the predominant clinical presentation of cADRs.
- Antimicrobial agents are the most frequently associated drug class with cADRs.
- Most cADRs exhibit a probable causal link to the implicated medication as per the Naranjo scale.
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