Skin rash on site of application of Dashanga Lepa (polyherbal formulation): A rare and unexpected drug reaction.

Dashanga Lepa is a polyherbal preparation of Ayurveda, used to treat many skin ailments and rheumatoid arthritis. However, its toxicological property has not been reported so far. We report a rare case of cutaneous adverse reaction in the form of skin rash following the application of Dashanga Lepa. A 42-year-old female patient with a Pittakaphalaprakruthi (constitution) developed skin rashes, soon after the application of Dashanga Lepa over the applied area, which disappeared after stopping the suspected drug and starting treatment with Shatadhauta ghritha. The patient was again treated with the same formulation after a span of a month, which led to the reappearance of a similar type of rash. The temporal relationship, positive dechallenge, and rechallenge are strong associations between the event and formulation. No such reaction was noticed by any other patient with the suspected medicine.

INTRODUCTION

Dashanga Lepa[1] is a polyherbal formulation consisting of 10 different herbs, such as, Shirisha (Albizzia lebbeck), Yashtimadhu (Glycyrrhiza glabra), Tagara (Valeriana wallichi), Rakta chandana (Pterocarpus santalinus), Ela (Elettaria cardomum), Jatamanshi (Nardostachys jatamansi), Haridra (Curcuma longa), Daruharidra (Berberis aristata), Kushta (Saussurea lappa), and Sugandha bala (Coleus vettiveroides).[2] It is used as a topical treatment in conditions like visarpa (herpes), Visha visphota (skin eruptions due to poison) and Dushta vrana (non-healing wound).[1] This formulation is found to be safe and dermatological manifestations are extremely rare. This article discusses a case of skin rash in a patient with rheumatoid arthritis, on the site of application of Dashanga Lepa. There is a strong association between the event and formulation. This kind of reaction with Dashanga Lepa is rare and unexpected. Recurrence of such a type of reaction is avoidable by properly detecting, evaluating, understanding and reporting such an event.

CASE REPORT

A 42-year-old, married, diabetic female presented with skin rash on the area around the knee joint, with itching, after applying Dashanga Lepa. She was suffering from rheumatoid arthritis since five years. The patient was admitted to KLE Ayurveda Hospital, Belgaum, Karnataka, for the treatment of rheumatoid arthritis. She was treated with Agnitundi vati (AFI), one tablet b.i.d and in the afternoon, Valuka Sweda (Mud fomentation therapy) followed by Dashanga Lepa as local application on both knee joints once a day. Agnitundi vati was stopped after three days and the remaining medications were continued. On the fifth day she was prescribed Dashanga Lepa twice a day (Morning and evening). Along with the above mentioned medications she was taking 1 tablet, 500 mg of Metformin (SR) in morning for her diabetes. The patient suddenly developed itching and redness with rashes around the applied areas, with a gap of 10 minutes of the second application.

Her history includes type-2 diabetes mellitus managed uneventfully with Metformin, since five years. She did not have any history of allergic skin diseases. Her Prakruti (constitution) was assessed as Pitta kapha prakriti (Pitta kapha constitution) by a standard questionnaire.[3] A lepa (semisolid paste) was prepared by mixing the Churna (Powder) of Dashanga Lepa (purchased from a Good Manufacturing Practices (GMP) certified company) with warm water.

Presentation of her condition was sudden, after the application of Dashanga Lepa, with itching, redness and rashes on and around the site of the application. The application of Dashanga Lepa was stopped immediately. The rashes were treated with a local application of Shatadoutha Ghritha[4] twice daily. No change was made in any other treatment. Within two days of treatment, the patient was completely relieved from the itching, rashes, and redness.

After one month of the above-mentioned incidence, the same patient was admitted for a second course of treatment. During this time she was given a similar line of treatment with Valukasweda, Agnitundivati and Dashanga Lepa. Even this time, the patient developed similar kind of rashes in the first application itself, for which application of Dashanga Lepa was stopped and she was treated again with Shatadoutha ghritha, twice daily and the patient was completely relieved from the symptoms on the third day.

Informed consent was obtained from the patient for documenting and publication. A copy of the written consent is available for review with the Editor-in-Chief of this journal.

DISCUSSION

Skin eruption is a commonly seen as a cutaneous adverse drug reaction.[5] Dermatological reaction to Dashanga Lepa is very rare. There are reports of skin rashes on the site of application, after topical application of Diclofenac gel.[6] This case report elaborates a case of skin rash on the site of application of Dashanga Lepa. There has been a temporal relationship, positive dechallenge and rechallenge, which points toward an association between the suspected formulation and the event. Causality assessment was done by the World Health Organization (WHO)-Uppsala Monitoring Center (UMC) Causality Assessment Scale and Naranjo's Adverse Drug Reaction (ADR) Probability Scale; the scores of which are Possible and Probable (Score 8) with Dashanga Lepa administration, respectively and severity was moderate. No such reaction was noticed by any other patient on the application of Dashanga Lepa and this points toward the susceptibility of the patient toward the reaction.

The technique of preparation of the Lepa, which the physician has followed is bit a different from the standard reference. As per classics[2] all the 10 ingredients need to be powdered and made into a kalka (semisolid paste) form and during application it is to be mixed with Ghritha (Ghee). Here Ghritha may help in preventing the toxic effects of the formulation and moreover, Ghritha has an antidotal effect in Pitta prakriti.[7] Many of ingredients of Dashanga Lepa have not been reported for their toxicity. However, Veleriane alkaloid, which is an active chemical constituent of Tagara (Valeriana wallichi) and Jatamanshi (Nardostachys jatamansi) has been reported to produce allergic reactions and contact dermatitis.[8] Furthermore, Costus oil (Kushta) has been seen to result in allergic contact dermatitis when used externally.[9] Hence, in this case, we believe that the event may have occurred because of improper selection of the treatment vehicle or sensitivity of some ingredients of the Dashanga Lepa.

This may be a good example for an unexpected or idiosyncratic reaction, because it is difficult to predict the cause and effect relation in modern pharmacology, like subacute thyroiditis following ginger consumption;[10] thus, it may be grouped under type-B type of the adverse drug reaction.

Such unpredictable adverse reactions are not necessarily due to errors or negligence. It is difficult to predict host susceptibility to such a response and thus, it becomes very important to document, evaluate and report such reactions. The present case shows that such rare and unpredictable adverse reactions are possible with Ayurvedic medications and the physicians need to be more vigilant to try and understand such reactions, so as to prevent its recurrence.

Such reports show the importance of the establishment of a pharmacovigilance cell in all Ayurvedic hospitals, so that information regarding ADR related to Ayurvedic formulations can be generated to study the ADR of Ayurvedic single herbs and formulations effectively.

This case has been reported to the National Pharmacovigilance Center for Ayurveda, Siddha and Unani (ASU) drugs on 10 November, 2011 and response is awaited (verified on 11 August, 2012).