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2019 Month : August Volume : 8 Issue : 34 Page : 2662-2666

Cutaneous Adverse Drug Reactions to Polyherbal Formulations - A Retrospective Study.

Sandhya Somasekharan Nair1, Smitha Ancy Varghese2

Corresponding Author:
Dr. Smitha Ancy Varghese,
Villa No. 3, Pebble Gardens,
Chembazhanthy, P. O.
Trivandrum-695587, Kerala, India.
E-mail: smitharijo@gmail.com

ABSTRACT

BACKGROUND

Although considered natural, herbal therapies can cause allergic reactions and even potentially dangerous side effects. In this article, we address cases of cutaneous adverse drug reactions (CADR) which are possibly related to polyherbal formulations (PHF).

METHODS

A retrospective study of ten years was carried out where the case sheets of patients admitted in dermatology ward of a tertiary care centre with cutaneous drug reactions were reviewed. Cases with clinical diagnosis of CADR along with history of intake of PHF were analysed. Demographic data, clinical type of drug reaction, drug history and blood investigations were recorded. Naranjo score was done to determine causality.

RESULTS

28 out of 506 patients (5.53%) where diagnosed with CADR possibly due to PHF (10 had maculopapular exanthema, 7 had exfoliative dermatitis, 4 cases had TEN, 2 had SJS, 2 had urticaria, and one patient each had DHS, angioedema, and fixed drug eruptions. Naranjo score of 5-6 implied ‘possible’ causality. Most were in the 30-40 years age group. Female to male ratio was 1.15:1. The commonest systemic association included hepatic involvement followed by renal involvement. All patients were treated with the withdrawal of the culprit drug and administration of systemic steroids and supportive measures. One patient with extensive TEN expired, thus giving a mortality rate of 3.4%.

CONCLUSIONS

PHF have an untapped potential that should be utilised. However, these drugs need to be scrutinised in the same way as any modern drug, i.e., via randomised controlled clinical trials.

KEY WORDS

Cutaneous Adverse Drug Reactions, Polyherbal Formulations

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