An observational study of cutaneous adverse drug reactions in a teaching hospital

Int J Clin Pharm. 2015 Dec;37(6):996-9. doi: 10.1007/s11096-015-0161-9. Epub 2015 Aug 4.

Abstract

Background: Pharmacotherapy is often impeded by adverse drug reactions (ADRs). Among these ADRs cutaneous reactions are the major class being easily identified and reported. If not noted early it has potential to develop into serious lesions.

Objective: To evaluate the clinical patterns of various drug induced cutaneous reactions. Setting A Teaching hospital in India. Methods All suspected cutaneous reactions to systemic drugs which were submitted to the ADR monitoring centre during a 6-month period (March 2014-August 2014) were analysed. Causality relationship, severity assessment and preventability assessment was also done.

Results: Out of 134 cutaneous ADRs, 56 % occurred in females, majority of cases were found in the age group of 41-50 years. The most common type of ADR was maculopapular rash (46.3 %) and majorly implicated drug class was antibiotics (51.3 %). Most (72.3 %) were mild. Polypharmacy and multiple comorbid conditions were important predisposing factors. Over half of the cases (58 %) were not preventable.

Conclusion: Cutaneous adverse reaction patterns and their causes vary as the result of changing use of drugs. In India, antibiotics are responsible for the majority of the cutaneous adverse drug reactions, and maculopapular rash is the side effect that is most reported.

Keywords: ADR; Causality; Cutaneous reactions India; Maculopapular rash; Pharmacovigilance India.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Anti-Bacterial Agents / adverse effects
  • Causality
  • Comorbidity
  • Drug Eruptions / epidemiology
  • Drug Eruptions / pathology*
  • Drug Monitoring
  • Female
  • Hospitals, Teaching
  • Humans
  • India
  • Male
  • Middle Aged
  • Parapsoriasis / pathology
  • Polypharmacy
  • Skin / pathology

Substances

  • Anti-Bacterial Agents