A fixed dose combination of ofloxacin and ornidazole induced fixed drug eruptions

Fixed drug eruptions (FDEs) may account for 16-21% of all cutaneous drug eruptions. Recent research suggests a cell-mediated process that initiates both the active and quiescent lesions. The major categories of causative agents of fixed drug eruption include antibiotics, antiepileptics, nonsteroidal anti-inflammatory agents, sildenafil, and phenothiazines, although numerous other agents and certain foods such as cashews and licorice have also been reported as causative agents. A 38 year old male presented to the dermatology OPD with hyperpigmented and erythematous macular eruptions on the neck, chest, right arm, left scapular region, left wrist and left knee. The eruptions were associated with burning sensation and itching. He informed having taken medications for gastroenteritis the night before. The medications were Ofloxacin and Ornidazole (FDC), Omeprazole and Domperidone (FDC) and Paracetamol. He gave a history of a similar event, a year ago, with the same antimicrobial combination (Ofloxacin and Ornidazole), although the macular eruptions were restricted to the neck, arm and knee with bleb formation and severe burning sensation. Since the macular eruptions reoccurred, although with extra regions being affected, a diagnosis of FDEs was made. The most probable cause for these FDEs seems to be FDC of Ofloxacin and Ornidazole, because the patient gives history of taking Omeprazole and Paracetamol before without any FDEs. According to Naranjo’s Adverse Drug Reaction Probability Scale, the FDC of Ofloxacin and Ornidazole is a definite cause for the FDEs. (Score = 9)

Amoxycillin and clavulanic acid induced Stevens-Johnson syndrome: a case report

Stevens-Johnson syndrome (SJS) is an immune complex mediated hypersensitivity complex that typically involves the skin and the mucous membranes. Various etiologic factors (e.g., infection, drugs and malignancies) have been implicated as causes of Stevens-Johnson syndrome. However, as many as half of the cases are idiopathic. Bastuji and Roujeau proposed that the denomination of Stevens-Johnson syndrome should be used for a syndrome characterized by mucous membrane erosions and widespread small blisters that arise on erythematous or purpuric maculae that are different from classic targets. In this case report, a 6 year old girl who was administered a cough syrup (containing bromhexine, guaiphenesin, diphenhydramine and phenylephrine) and amoxycillin and clavulanic acid dispersible tablet for the treatment of cough developed pruritic skin eruptions all over the body along with painful erosions on the tongue, buccal mucosa, genital and anal mucosa. A diagnosis of Stevens-Johnson syndrome was made. Amoxycillin and clavulanic acid combination was identified as the culprit based on the temporal relationship between the drug administration and the appearance of the rashes and based on a number of SJS reports implicating amoxycillin and clavulanic acid having been published before. The cough syrup and amoxycillin and clavulanic acid combination tablets were immediately stopped. Symptomatic treatment was administered. The child improved and was later discharged. Causality assessment using Naranjo adverse drug reaction probability scale revealed that amoxycillin and clavulanic acid combination was a possible cause for the harmful cutaneous adverse reaction with a score of 4

Impact of educational intervention on awareness of pharmacovigilance among medical undergraduates in Karnataka, India: a cross-sectional study

Background: India being a part of national pharmacovigilance program (NPP), its contribution to UMC (Uppsala monitoring centre) is very little and pharmacovigilance program of India (PvPI) is still in its infancy. Lack of vibrant reporting culture necessitates bringing the awareness and importance of it. Objective of this study was to assess the level of knowledge, awareness, and the method of application of pharmacovigilance (PV) and to evaluate the impact of an educational intervention among second year medical students for improving awareness of pharmacovigilance.Methods: This was a cross-sectional questionnaire based study conducted among 146 students in a tertiary care teaching hospital in B.G. Nagara, Mandya, Karnataka, India. Purpose of the study was explained to all the participants. Pretest questionnaires were distributed and filled questionnaires were collected following the educational intervention through continued medical education (CME), same questionnaire was given as post-test questionnaire. Both the test results were analysed to know the educational impact.Results: Out of 146, a total 130 medical students were involved in pre and post-test questionnaire. The overall response rates between pre and post intervention had improved in majority of the medical undergraduates which brings out the effectiveness of intervention for improving the reporting system.Conclusions: Educational intervention was more effective in improving student’s knowledge, awareness and applications of pharmacovigilance. Early sensitization through educational interventions in II phase of MBBS itself enhances the reporting frequency in future through their active participation & emphasizing the need to design the suitable strategies to develop vibrant as well as voluntary reporting culture

A fixed dose combination of ofloxacin and ornidazole induced fixed drug eruptions

Fixed drug eruptions (FDEs) may account for 16-21% of all cutaneous drug eruptions. Recent research suggests a cell-mediated process that initiates both the active and quiescent lesions. The major categories of causative agents of fixed drug eruption include antibiotics, antiepileptics, nonsteroidal anti-inflammatory agents, sildenafil, and phenothiazines, although numerous other agents and certain foods such as cashews and licorice have also been reported as causative agents. A 38 year old male presented to the dermatology OPD with hyperpigmented and erythematous macular eruptions on the neck, chest, right arm, left scapular region, left wrist and left knee. The eruptions were associated with burning sensation and itching. He informed having taken medications for gastroenteritis the night before. The medications were Ofloxacin and Ornidazole (FDC), Omeprazole and Domperidone (FDC) and Paracetamol. He gave a history of a similar event, a year ago, with the same antimicrobial combination (Ofloxacin and Ornidazole), although the macular eruptions were restricted to the neck, arm and knee with bleb formation and severe burning sensation. Since the macular eruptions reoccurred, although with extra regions being affected, a diagnosis of FDEs was made. The most probable cause for these FDEs seems to be FDC of Ofloxacin and Ornidazole, because the patient gives history of taking Omeprazole and Paracetamol before without any FDEs. According to Naranjo’s Adverse Drug Reaction Probability Scale, the FDC of Ofloxacin and Ornidazole is a definite cause for the FDEs. (Score = 9)

Amoxycillin and clavulanic acid induced Stevens-Johnson syndrome: a case report

Stevens-Johnson syndrome (SJS) is an immune complex mediated hypersensitivity complex that typically involves the skin and the mucous membranes. Various etiologic factors (e.g., infection, drugs and malignancies) have been implicated as causes of Stevens-Johnson syndrome. However, as many as half of the cases are idiopathic. Bastuji and Roujeau proposed that the denomination of Stevens-Johnson syndrome should be used for a syndrome characterized by mucous membrane erosions and widespread small blisters that arise on erythematous or purpuric maculae that are different from classic targets. In this case report, a 6 year old girl who was administered a cough syrup (containing bromhexine, guaiphenesin, diphenhydramine and phenylephrine) and amoxycillin and clavulanic acid dispersible tablet for the treatment of cough developed pruritic skin eruptions all over the body along with painful erosions on the tongue, buccal mucosa, genital and anal mucosa. A diagnosis of Stevens-Johnson syndrome was made. Amoxycillin and clavulanic acid combination was identified as the culprit based on the temporal relationship between the drug administration and the appearance of the rashes and based on a number of SJS reports implicating amoxycillin and clavulanic acid having been published before. The cough syrup and amoxycillin and clavulanic acid combination tablets were immediately stopped. Symptomatic treatment was administered. The child improved and was later discharged. Causality assessment using Naranjo adverse drug reaction probability scale revealed that amoxycillin and clavulanic acid combination was a possible cause for the harmful cutaneous adverse reaction with a score of 4

Practice patterns and outcomes with the use of regorafenib in metastatic colorectal cancer: Results from the Regorafenib in Metastatic colorectal cancer - An Indian exploratory analysis study

Background: Regorafenib is considered a standard of care as third-line therapy in metastatic colorectal cancers (mCRCs). Materials and Methods: The study was based on a computerized clinical data form sent to oncologists across the country for entry of anonymized patient data. The data entry form was conceived and generated by the coordinating center's (Tata Memorial Hospital) gastrointestinal medical oncologists and disseminated through personal contacts at academic conferences as well as through E-mail to various oncologists across India. Results: A total of 19 physicians contributed data resulting in 80 patients receiving regorafenib who were available for the evaluation of practice patterns. The median age was 55 years (range: 24–75). Majority had received oxaliplatin-based (97.5%), irinotecan-based (87.5%), and targeted therapy (65%), previously. Patients were primarily started on reduced doses of regorafenib upfront (160 mg – 28.8%, 120 mg – 58.8%, and 80 mg – 12.5%). The median duration of treatment (treatment duration) with regorafenib was 3.1 months (range: 0.5–18), while the median progression free survival was 3.48 months (range: 2.6–4.3). Forty-five percent of patients required dose modifications due to toxicities, and the most common were (all grades) hand-foot syndrome (68.8%), fatigue (46.3%), mucositis (37.6%), and diarrhea (31.3%). Conclusions: Majority of physicians in this collaborative study from India used a lower dose of regorafenib at the outset in patients with mCRC. Despite a lower dose, there was a significant requirement for dose reduction. Duration of treatment with regorafenib as an efficacy end point in this study is similar to available data from other regions as it is the side effect profile