Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India

Authors

  • Vijaya Chandra Reddy Konda Department of Pharmacology, Sri Venkateswara Institute of Medical Sciences, Sri Padmavathi Medical College for Women, Tirupati, Andhra Pradesh, India
  • Sree Surya Durga Devi Pilla ADR Monitoring Centre, Sri Venkateswara Institute of Medical Sciences, Sri Padmavathi Medical College for Women, Tirupati, Andhra Pradesh, India
  • A. Surekha Department of Dermatology, Sri Venkateswara Institute of Medical Sciences, Sri Padmavathi Medical College for Women, Tirupati, Andhra Pradesh, India
  • K. R. Subash Department of Pharmacology, Sri Venkateswara Institute of Medical Sciences, Sri Padmavathi Medical College for Women, Tirupati, Andhra Pradesh, India
  • K. Umamaheswara Rao Department of Pharmacology, Sri Venkateswara Institute of Medical Sciences, Sri Padmavathi Medical College for Women, Tirupati, Andhra Pradesh, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20185085

Keywords:

Adverse drug reaction monitoring centre, Cutaneous adverse drug reactions, Causality, Pharmacovigilance

Abstract

Background: Skin is the most common organ involved in adverse reactions due to drugs. With newer drugs released into market every year, there is changing pattern of the reported cutaneous adverse drug reactions (ADRs). In order to ensure safer use of medicines in patients, there is need for continuous monitoring of ADRs. This is a retrospective study to analyse spontaneously reported cutaneous ADRs.

Methods: All the cutaneous ADRs reported between January 2017 and September 2018 were analysed for clinical patterns, suspected medications, causality, severity and preventability.

Results: Of the 1035 reports received during the study period, 232 (22.41%) included cutaneous reactions. 113 (48.7%) were male and 119 (51.29%) were female. Maculopapular rash 70 (30.17%), pruritus 31 (13.36%), palmar plantar erythrodysesthesia 30 (12.93%), acne 19 (8.19%), urticaria 16 (6.89%) and fixed drug eruptions (FDE) 13 (5.6%) were the common clinical patterns. Antimicrobial agents followed by anticancer drugs, nonsteroidal anti-inflammatory drugs (NSAIDs), hormones and related drugs, and antiepileptic drugs were the common suspected group of drugs. Causality assessment as done by WHO-UMC scale showed that 3 (1.29%) were certainly related, 174 (75%) were probably related and 55 (23.7%) were possibly related to the suspected medication.

Conclusions: Cutaneous ADRs are most frequently reported ADRs in the present study. With newer drugs released into market, there is a need for continuous monitoring of use of drugs to promote safer use of medicines in patients.

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Published

2018-12-24

How to Cite

Konda, V. C. R., Pilla, S. S. D. D., Surekha, A., Subash, K. R., & Rao, K. U. (2018). Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India. International Journal of Basic & Clinical Pharmacology, 8(1), 27–33. https://doi.org/10.18203/2319-2003.ijbcp20185085

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Original Research Articles