DOI: http://dx.doi.org/10.18203/2320-6012.ijrms20163292

Fixed drug eruptions: causing drugs, pattern of distribution and causality assessment in a leading tertiary care hospital

Rahul Saini, Bhawana Sharma, Prem Kumar Verma, Seema Rani, Garima Bhutani

Abstract


Background: It is bitter truth that there is no drug in this world which is without an adverse drug reaction (ADR). After the clinical trials when the drug comes in market or when it is taken by variety of population then actual reality of the drug comes out about its efficacy and adverse drug reactions. Fixed drug eruption is also one such type of ADR in which a specific type of lesions occurs over the skin after the drug is taken.

Methods: We have conducted a clinical, observational study, in BPS Government Medical College, Khanpur Kalan, Sonepat, Haryana, India over a period of eight months. In that period we have found 159 patients having adverse drug reactions. Patients of both genders, under all age group were included in the study.

Results: Out of 159 adverse drug reactions reports 69 (43.39%) were cutaneous adverse drug reaction report, 45 (28.30%) cases were of fixed drug eruption (FDE). Out of these 45 cases seen, there were 4 males (8.88%) and 41 females (91.11%). Flouroquinolone antibiotics like ciprofloxacin, ofloxacin and norofloxacin were the most common drugs causing fixed drug eruption followed by nitroimadazole antibiotic like metronidazole, tinidazole and NSAIDS like diclofenac, paracetamol and meftal spas in our study. FDE are more common in upper limbs extremities followed by lower limb extremities than face and trunk. Causality assessment was done with the help of WHO UMC scale and we found that association was possible in all the cases.

Conclusions: Fixed drug eruptions are one of the major types of adverse drug reactions and should be assessed and reported.


Keywords


Pharmacovigilance, FDE, ADR

Full Text:

PDF

References


Patro N, Panda M, Jena M, Mishra S. Multifocal Fixed Drug Eruptions: A Case Series. Int. J. Pharm. Sci. Rev. Res., 2013;23(1):63-6.

Wolff K, AJ Richard, Surmond D. Colour atlas and synopsis of Clinical Dermatology: 5th edition. McGraw Hill: 2005:556.

Kavoussi H, Rezaei M, Derakhshandeh K, Moradi A, Ebrahimi A, Rashidian H, et al. Clinical Features and Drug Characteristics of Patients with Generalized Fixed Drug Eruption in the West of Iran (2005–2014). Derm Res Prac. 2015;15:4 .

Mehta TK, Marquis L, Shelty JN. A Study of seventy cases of drug eruptions. Ind J Derm, Vene Lep. 1971;37:1-5.

Sharma VK, Dhar S, Gill AN. Drug related involvement of specific sites in fixed eruptions: a statistical evaluation. J Dermatol. 1996;23:530-4.

Sharma VK, Sethuraman G, Kumar B. Cutaneous Adverse drug reaction patterns to Antimicrobial drugs in North- India. J Assoc Physicians India. 1998;46:1012.

Gowri Thilagam T, Parameswari R, Shanthi M, Uma D, Mathivani M. A study of drugs causing fixed drug eruptions in a Tertiary Care Hospital. Int J Phar Life Sci. 2013;4(10): 3018-22.

Bertram G.K, Susan B.M, Anthony JT. Basic and clinical pharmacology. 11th edition. 2009:73.