Evaluation of adverse drug reactions in patients of schizophrenia in tertiary care teaching hospitals in Central India

Background: For decades, it has been observed that mental health is shrouded in stigma and discrimination. The scope, severity, and expense of impairment and costs to people, families, and societies are staggering. Mental illnesses are among the most frequent illnesses, affecting over a quarter of the population in any given year. According to national institute of mental health and neurosciences, Bangalore, the prevalence of schizophrenia has been considered as 4/1000 for all ages and both sexes. Aim and Objectives: The objectives of this study were to as follows: (1) To evaluate adverse drug reactions (ADRs) in patients with schizophrenia who received antipsychotic treatment and (2) to compare ADRs in typical versus atypical antipsychotic agents in schizophrenic patients. Materials and Methods: A total of 50 schizophrenic patients were enrolled for evaluating adverse effects to antipsychotic drugs. During the research, all ethical precautions were taken. All patients were followed up by medical history, history of drugs, and any severity of adverse drug reaction. Causality assessment was graded by Naranjo scale. Result: Among all of the antipsychotic drugs, risperidone (05%), quetiapine (04%), and aripiprazole (04%) have shown lowest propensity to cause serious adverse event. These drugs are most commonly prescribed drugs and are least likely to affect quality of life of patient. However, the risk of extrapyramidal symptoms is lower with olanzapine (05%) than haloperidol (34%) and even in case with risperidone at higher dose (20%). Although atypical antipsychotics such as olanzapine (46%) have shown maximum potential to produce metabolic side effect such as dyslipidemia and hyperglycemia compared to that of other antipsychotics. Conclusion: The most common adverse effects were found with typical and atypical antipsychotics such as weight gain, drowsiness, constipation, sedation, dyslipidemia, and hypotension.

COVID-19 vaccination and recurrent anterior uveitis

A 35-year-old Asian Indian female previously diagnosed with bilateral anterior uveitis and on oral methotrexate developed bilateral anterior uveitis following first/second dose of coronavirus disease 2019 (COVID-19) vaccination. She had skipped her weekly dose of oral methotrexate following first dose of vaccination. Following the second dose, she reduced her oral methotrexate from 25 to 15 mg on her own, but did not stop like the previous occasion. She had extensive workup for her uveitis in the past with only positive severe acute respiratory syndrome coronavirus (SARS-CoV-2) antibodies. She developed unilateral anterior uveitis after she had COVID-19 in July 2022, which resolved with topical steroids and continuation of immunosuppression. This report illustrates that COVID-19 or its vaccination may presumably play a role in triggering the immune system and can cause recurrent ocular inflammation even in the absence of an extraocular inflammation.

A prospective study of adverse drug reactions of antipsychotic drugs in a tertiary care public psychiatry hospital

Background: Antipsychotic drugs are commonly used pharmacological agents, which have varied adverse reactions. There is a need to investigate the prevalence of these adverse reactions due to the implications for clinical practice and research. Studies on the prevalence of these adverse reactions are few, especially from Indian subcontinent. Aim and Objectives: The objectives of this study were as follows: (i) To investigate the drug emergent adverse drug reactions (ADRs) in patients who are on antipsychotic drugs and (ii) to study the severity of ADRs due to antipsychotic agents and association between the adverse reaction and the suspected drug. Materials and Methods: This is a prospective observational study, in which 99 patients out of 120 patients suffering with mental illness were enrolled. Base-line investigations such as CBP, ESR, serum creatinine, serum electrolytes, serum cholesterol, serum prolactin, and FBS (fasting blood sugar) were performed and the same were repeated at 1st month and 3rd month and checked for any abnormality. Any suspected ADRs were noted after 1 month and 3 months in patients after starting the treatment with antipsychotic drugs. The patients were assessed with semi-structured interview, the patient rated side effects scale (LUNSERS), and an adverse drug probability scale (Naranjo probability scale). The results were analyzed with SPSS software. The ADRs in patients were also compared between in-patients and out-patients. Results: The atypical drugs particularly risperidone and olanzapine were commonly prescribed for the patients, than typical antipsychotic drugs such as haloperidol. Out of the 99 patients, risperidone was prescribed for 56.6% of patients, olanzapine was prescribed for 40.4% patients, amisulpride was prescribed for 1% of patient, and haloperidol for 2% of patients. About 79% of the patients under study developed ADRs within a month and 21% developed after a month. These drugs were given twice-daily dosage regimen for 89.9% of the patients than once daily dosage regimen, which is 10.1%. Forty-one were in-patients and 58 patients were out-patients. Among the in-patients, risperidone drug was given for 28 (68.3%) patients, olanzapine was given for 11 (26.8%) patients, amisulpride for 1 (2.4%) patient, and haloperidol for 1 (2.4%) patients. The most common ADRs in in-patients was EPS (90.24%) with a statistically significant P < 0.0001. In out-patients, risperidone was prescribed for 28 (48.3%) patients, olanzapine was given for 29 (50%) patients, and haloperidol for 1 (1.7%) patient. The most common ADR among out-patients was sedation (82.75%) with P = 0.0001, which is statistically significant. The ADRs were “significant” according to LUNSERS overall score and are “probable” according to Naranjo’s probability assessment scale. Conclusion: The most common antipsychotic drugs used were risperidone and olanzapine. The common drug emergent adverse reactions were EPS and sedation when the drugs were prescribed twice-daily dosage regimen. The time taken for these ADRs to emerge is ?1 month. The ADRs are significant according to LUNSERS and probable due to suspected drug according to Naranjo’s probability assessment scale. In comparison between in-patients and out-patients, EPS was found more among in-patients and sedation in out-patients. Depending on the intensity of the ADRs, the antipsychotics drug dosage was reduced or drug changed or another was added to combat the ADRs.

Evaluation of adverse drug reactions in patients with Type II diabetes mellitus in tertiary care hospitals, Bhopal

Background: Pharmacovigilance is the science which deals with adverse drug reactions (ADRs) appear after long and short drug treatment. ADRs monitoring is essential to gain knowledge of drugs reaction for betterment of mankind. In the present study, observation of ADRs in Type II diabetic patients was conducted in tertiary care hospitals, Bhopal. ADRs reported in the present study were diarrhea, myalgia, flatulence, palpitations, rash, itching, etc., in patients receiving oral hypoglycemic agents. So through this observation, we want to acknowledge the various adverse effects occurred by oral hypoglycemic agents for reduction of morbidity and mortality in Type II Diabetic patients. Aims and Objectives: (1) The objectives of the study were to ADRs monitoring in Type II Diabetic patients receiving oral anti-diabetic agents and (2) to compare ADRs in conventional versus newer anti-diabetic agents therapies in Type II Diabetic patients. Materials and Methods: 150 patients were enrolled for evaluating adverse effects with oral antidiabetic agents. All patients were followed up by medical history, history of drugs, and any severity of ADR. Causality was graded by Naranjo scale. Results: 45 patients (30%) with mean age of 64.6 year (SD = 2.41) complained adverse effects and out of which 17 (11.3%) patients were reported to the physician. The most common adverse effect was found with sulfonylureas, biguanides, and thiazolidinediones such as hypoglycemia, weight gain, gastrointestinal (GI) disturbances allergic reactions, and dizziness probability of adverse effects more common in females (64.17%) in comparison to male (35.29%) patients. Conclusion: In Type II Diabetic patients receiving oral antidiabetic agents provides a fruitful information about a ADRs and enhance knowledge about pharmacovigilance to health-care providers. However, predominance of adverse effects in female diabetic patients was reported. Hypoglycemia, weight gain, and GI tract disturbances were observed frequently with oral antidiabetic agent in middle age diabetic patients. By this information, we can prevent drug related complications and improve quality of life of a person

Study of pattern & distribution of adverse drug reactions in acute coronary syndrome patients in a tertiary care hospital

Background & objectives: With the availability of a wide range of drugs to treat patients with acute coronary syndrome (ACS), adverse drug reactions (ADRs) have become inevitable in clinical practice. Thorough knowledge of such reactions is essential for the treating physician for optimal treatment and better outcomes. There are many scales to define, measure and assess the ADRs, but there is a dearth of data available on such drug reactions among ACS patients. Hence, this study attempted to analyze the pattern, causality, severity, predictability and preventability of ADRs in ACS patients. All the ADRs reported during the study period were analyzed for causality by the World Health Organization–Uppsala Monitoring Centre (WHO-UMC), Naranjo’s and Karch and Lasagna scales; severity by modified Hartwig and Siegel scale; predictability by Rawlins and Thompson criterion and preventability by Schumock and Thornton scale. Methods: A single-centre, record-based analysis for the occurrence of ADRs was done among ACS patients admitted to the department of Cardiology between January and October 2017. Demographic data, comorbid conditions, reported ADRs and ADR assessment details were noted from the hospital case records and ADR monitoring centre (AMC) records. The data were analyzed and presented in a descriptive manner using percentages, mean and standard deviation. The Pearson’s chi-squared test was used to ascertain the significance of the association between different groups. Results: Out of 324 patients under evaluation, 67 had developed one or more ADRs. There were 30 different types of ADRs reported, headache being the most common. Among the drugs, heparin was the most common factor, causing 27 per cent of ADRs. Definite causality of a suspected drug causing ADRs was seen in 11.9 (n=8), nine (n=6) and 7.5 (n=5) per cent cases as per WHO-UMC, Naranjo (Naranjo algorithm) and Karch and Lasagna scales, respectively. In the severity of ADRs, the most severe reactions according to the modified Hartwig-Siegel scale (level 4a in our study) were seen in 17.5 (n=12) per cent of patients, and the rest were either level 2 or 3 reactions. Nearly 92.5 (n=62) per cent of reactions were predictable according to the Rawlins and Thompson criterion. Application of the modified Schumock-Thornton scale showed that 22.4 per cent of ACS patients had preventable reactions, and the rest were not preventable.Interpretation & conclusions: The study results suggest that ADRs are relatively common among ACS patients. Most of these can be identified and assessed for causality, severity, predictability and preventability using various available scales. Diligent pharmacovigilance for identifying and assessing ADRs may help manage and mitigate morbidity associated with these in high-risk ACS patients.

A retrospective cross-sectional study to evaluate the adverse drug reactions reported in the tertiary care health center in Northern India

Background: In terms of morbidity and death, adverse drug reactions (ADR) have been highlighted as a worldwide burden. Determining the origin of ADRs remains a tough issue and no one approach for determining causation has been adopted as the gold standard throughout the world. Aim and Objectives: The objectives of the present study were (1) to evaluate the causality of ADRs using World Health Organization-Uppsala Monitoring Center (WHO-UMC) and Naranjo Algorithm ADRs causality assessment tools and (2) to evaluate the agreement and correlation between two universally used approaches for causality assessment of ADRs viz. WHO-UMC system and Naranjo algorithm. The secondary objective was to assess the reported ADRs in a tertiary care hospital in Northern India. Materials and Methods: The present study was a retrospective cross-sectional study. A total of 180 patients of ADRs from different departments of tertiary care hospital which were reported by Pharmacovigilance unit over a period of April 2018 to May 2019 were assessed. The causality assessment for these reported ADRs were done by WHO-UMC system and Naranjo algorithm. The agreement between these two methods calculated by Cohen’s kappa (?) statistics and Spearman’s correlation was used to evaluate the correlation between these two methods. Results: According to WHO-UMC criteria, 55.5% of adverse event instances were of the probable type, 34.4% were possible, 9.4% of cases were improbable, and 0.5% of cases were definite. According to the Naranjo methodology, 80.5% of adverse outcomes were likely, while 19.4% were feasible. The WHO and Naranjo causality comparisons had a positive and fair agreement (= 0.29), according to Cohen’s kappa test. Between the WHO-UMC scale and the Naranjo algorithm, the Spearman’s correlation coefficient was determined to be 0.409. Conclusion: “Probable” was the most common causality category observed by the WHO-UMC scale and the Naranjo algorithm. The WHO-UMC scale and the Naranjo algorithm have a good and reasonable agreement.

Effectiveness And Safety Assessment Of Fixed Dose Combination Of Non-Steroidal Antiinflammatory Drugs Prescribed For Orthopedic Patients

Objective: Many Fix Dose Combinations (FDCs) being introduced in India are usually irrational. The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions, for instance, pediatric formulations of nimesulide+paracetamol. Despite their wide clinical use, their gastro-intestinal toxicity is a major limitation. The aim of the present work was to evaluate the efficacy and safety of FDCs in non-steroidal anti-inflammatory drugs in the orthopedic department at a tertiary care teaching hospital. To study the effectiveness and safety parameters of fixed-dose combinations of Non-Steroidal Anti-inflammatory Drugs. Methods: This prospective, observational study was conducted among 150 out-patients of the orthopedic ward over a period of July 2013 to December 2013(Each combination with 50 patients). Three fixed-dose combinations utilized were paracetamol+diclofenac, paracetamol+ibuprofen and paracetamol+nimesulide. The effectiveness was analyzed by using Visual Analogue Scale (VAS) and Disease Activity Scale (DAS) and the safety criteria were analyzed by using the WHO probability scale and Naranjo scale. 150 orthopedic patients attending Out Patient Department were included. 50 participants for each of the combinations of fixed-dose combination (FDCs) of NSAIDs. Results: Out of 150 patients 33 patients developed adverse effects, and 17(51.51%) adverse effects due to the combination of Paracetmol+Nimuselide, 11(33.34%) adverse effects due to the Paracetamol+Ibuprofen and 5 (15.15%) were due to the combination of Paracetamol+Diclofenac. The maximum effectiveness (3.55±0.208) showed in the combination of paracetamol+diclofenac compared to the other two combinations. Conclusion: It was concluded from this study that the effectiveness and safety profile of PCM+DICLO is better than the other two FDCs.

Drug Utilization Evaluation Of Benzodiazepines In A Tertiary Care Hospital

Objective: To assess the rationale use of benzodiazepines among various departments in a multi-speciality hospital. Methods: A prospective study was conducted with a sample size of 200 for a period of six months. Data was collected from patients based on inclusion and exclusion criteria. Naranjo Adverse Drug Reaction Probability Scale and Drug Interaction Probability Scale (DIPS) were used as a study tool to measure the causality of adverse drug reactions and drug interactions. Based on the dosage of various benzodiazepines DDD was calculated and compared with WHO Anatomical Therapeutic Chemical (ATC) classification Defined Daily Dose (DDD). Results: BZD’s were mostly prescribed in males (74.5%) and married patients (86.5%) were more exposed to benzodiazepines compared to others. Lorazepam (70.1%) was found to be the most commonly used drug, mainly prescribed for sedation, followed by anxiety. DDD was calculated and majority of patients had DDD in accordance with WHO standard. Based on cost analysis, Clobazam was found to be the high cost and Lorazepam being the low-cost drug. The results of drug utilization evaluation of benzodiazepines study were compiled and reported to the respected department physician and their feedback was collected. Conclusion: The study showed a rational utilization of benzodiazepines and the negative outcomes of BZDs can be reduced by providing drug-related information to the prescribers and consumers.

Study of adverse drug reactions in a tertiary care hospital

Background: The objectives of the study were to evaluate incidence and preventability of adverse drug events (ADEs) and potential ADEs and to analyse preventable events to develop prevention strategies.Methods: The study was retrospective observational study conducted at a rural tertiary care hospital at Maharashtra, for 12 months. Patients of both gender and all age group were included in the study. These entire adverse drug reactions were reported either by the PVPI assistance and/or hospital staff and their severity and causality assessments was performed as per Naranjo’s and Hartwig’s assessment criteria respectively. Data was analyzed by using Microsoft Excel.Results: There were total 256 ADR (adverse drug reactions) were reported in 12 months from January 2018 to December 2018 in various departments of the study center. Most of the adverse drug reactions were reported among age group of 21–40 years patients. Rash and itching (69) were most commonly reported ADR’s. ART (31.25%), antibiotics (28.90%) were reported to induce maximum number of ADRs. Most of the adverse drug reactions were possible (194, 75.78%) and mild (208, 81.25%) in nature.Conclusions: The antibiotics, ART drugs were most common drugs to reported ADRs. The commonly reported reactions were rash and itching.

Phenytoin induced toxic epidermal necrolysis: a case report

Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), are severe idiosyncratic reactions characterized by fever and mucocutaneous lesions leading to necrosis and sloughing of the epidermis. The usage of anticonvulsants like carbamazepine, phenytoin, lamotrigine, phenobarbital are associated with high risk for occurrence of TEN. We present a case of toxic epidermal necrolysis in a 30 year old female probably induced by phenytoin. A 30 year old female was admitted to the emergency medicine department of KIMS hospital, Bengaluru. Lesions over the lips and oral cavity, multiple fluid filled blisters were present diffusely all over the body. Patient had a past history of oral cavity lesions with injection phenytoin. Patient is a known epileptic of over 12 years and was on treatment. Patient had a seizure attack 3 days back and visited nearby hospital and did not inform the doctor of her allergy to phenytoin. Patient was given inj phenytoin after which she developed oral lesions and also presented with fluid filled bullae all over the body. A diagnosis of toxic epidermal necrolysis was made based on clinical history and Scoreten score and was treated with betadine wash, fluconazole and antibiotics .The lesions improved significantly with the above management and patient recovered enough to be discharged from the hospital after 5 days. Severe and serious reactions such as toxic epidermal necrolysis can be caused by commonly used drugs like phenytoin.

Furosemide induced bullous pemphigoid: a case report

Bullous pemphigoid is an acquired autoimmune disease characterized by subepidermal vesicles and bullae. The etiology is mostly idiopathic with the highest occurrence in elderly patients. However, it is now well-accepted that bp has been triggered by or associated with drug therapy. Over 50 agents have been implicated as a cause of Drug-induced bullous pemphigoid, including diuretics, ace inhibitors, and antibiotics. We present a case of Bullous pemphigoid in a 75 year old male probably induced by furosemide. A 75 year old male was admitted to the dermatology department of KIMS hospital, Bengaluru. Presented with multiple tense bullae and vesicles over both upper limbs, forearm and few collapsed bullae and vesicles over the extensor aspect of forearm. Patient had a past history of myocardial infarction and undergone coronary artery bypass grafting for the same and treated with multiple medications. Among the treatment given injection furosemide was the one of the drug, after which he developed lesions and also presented with fluid filled bullae. A diagnosis of bullous pemphigoid was made based on clinical history and was treated with prednisolone, halobetasol and antibiotics. The lesions improved significantly with the above management and patient recovered enough to be discharged from the hospital after 5 days. Severe and serious reactions such as bullous pemphigoid can be caused by used drugs like furosemide.

A study of adverse drug reaction profile of tuberculosis patients attending DOTS center at Dr. Bhim Rao Ambedkar memorial hospital, Raipur, Chhattisgarh, India

Background: Tuberculosis is second leading cause of death in the world. The causative organism is Mycobacterium tuberculosis. The objective was to study the adverse reactions of the patients attending the DOTS center and to assess their causality and severity of reported ADRs.Methods: Present study was a prospective observational study carried at the DOTS center of Dr. Bhim Rao Ambedkar Memorial Hospital, Raipur, Chhattisgarh, India between August 2011 to July 2012 (One year). The patients were monitored for adverse drug reactions. The assessment of ADRs were based upon the WHO assessment scale, Naranjo scale, European A.B.O scale.Results: Total number of patients attending DOTS center was 816. The number of males (428) exceeded that of females (388). Majority of patients in this study belonged to 21-30 years (26.96%) next 31-40 years (25.24%) and 41-50 years (16.5%) of age group. Prevalence of ADRs were more in males (57%) than in females 32 (43%). Majority of ADRs reported were moderate 33 (35.22%) followed by 29 (46,77%) were mild, no severe ADRs reported. According to severity of ADRs seen were gastritis 28 (45%) followed by 10 (16% ) rashes , 10 (16,12%) of arthralgia, 3 (4.83%) of hepatitis, 6 (9.7%) of peripheral neuropathy, 2 (3%) onsets of ADRs after starting anti-tubercular drug were 12 (19.35%) in 0-1 week followed by 19 (30%) ADRs showed onset in 1-2 week and 2-3 week, 8 (13%) in 3-4 week 3 (5%) in 4-5 week and 1 (2%) in 5-6 week.Conclusions: The casual link between the ADRs and the suspected anti-tubercular drug by Naranjo scale definitely relationship was established between the anti-tubercular drug and ADRs in 7 (11.25%) patient while 22 (35.45%) probable and 33 (53.22%) ADRs were categorized as possible.

An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India

Background: There were 4.1% of all new cases and 19% of previously treated patients were diagnosed with either multidrug resistant or rifampicin resistant tuberculosis in 2016. In the state of Uttar Pradesh, there were 2.16 new cases and 44,531 previously treated cases. The objectives of the study were to assess the predisposing factors, causality assessment, severity grading and avoidability of the adverse drug reactions (ADRs) of the antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This prospective observational study was conducted for 12 months at a tertiary care hospital. The patients with MDR tuberculosis on treatment with DOTS Plus regimen under RNTCP and who met the inclusion exclusion criteria were recruited after informed consent. ADRs were monitored daily till the patients remained admitted and thereafter monthly. Predisposing factors were recorded. Causality assessment was performed by Naranjo scale and WHO UMC scale, severity by Hartwig’s scale and avoidability by Halla’s scale.Results: There were 115 patients were recruited, 70 developed at least one ADR. 98 ADRs were reported. The commonest ADR reported were – gastrointestinal (38.76%), neurological (21.24%) and hepatobiliary (8.16%). Diabetes and HIV predisposed to development of ADRs. 58.18% ADRs were classified as possible and 37.5% as probable by Naranjo’s scale. 51.02% ADRs were classified as probable and 42.83% as possible by WHO-UMC. 56% were classified as mild, 36% moderate, and 6% severe via Hartwig’s scale. 51 ADRs were classified as avoidable and 40 ADRs were possibly avoidable.Conclusions: Monitoring and assessment of ADRs is necessary to promote awareness, curb resistance and maintain adherence.

Medication Therapy Management Practice of A Chronic Disease Patient with Adverse Drug Reactions Caused by Candesartan / 中国药房

OBJECTIVE： To provide reference for the evaluation of the correlation between drugs and adverse drug reaction （ADR） and the implementation of medication therapy management （MTM）. METHODS： Clinical information of a elderly patient with chronic disease （hypertension and coronary heart disease） whose suffered from leukocyte and platelet counts reduction and abnormal liver biochemical examination after taking candesartan were analyzed retrospectively in outpatient department of Tianjin Third Central Hospital. MTM pharmacists analyzed the correlation of candesartan with ADR using Naranjo evaluation scale method. The reasons for abnormal liver biochemical examination were analyzed by Naranjo evaluation scale method combined with Roussel Uclaf causality analysis method （called RUCAM method for short）. The medication reconciliation was conducted according to the results， and pharmacists cooperated with doctors to set individualized medication regimen and follow-up. RESULTS： By Naranjo evaluation scale method， analysis results showed that candesartan was “probably related” to ADR. By RUCAM method， analysis results showed that candesartan was “probably related” to liver biochemical abnormalities. MTM pharmacists suggested that candesartan should be stopped in time and the patient’s medication should be adjusted. The physician and the patient adopted the pharmacist’s advice. After 38 days of drug withdrawal， the patient’s ADR symptoms disappeared， and leukocyte count， platelet count and liver biochemical examination were normal. After adjustment of medication， the patient was followed up for 6 months with normal blood pressure. CONCLUSIONS： Naranjo evaluation scale method and RUCAM are simple and feasible in evaluating the correlation of drugs with ADR and hepatotoxicity. The two methods are consistent in evaluating the correlation between drugs and hepatotoxicity. Naranjo scale method and RUCAM method can be combined to analyze the correlation between drugs and ADR with abnormal liver biochemical examination.

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).

Clonazepam associated hypothyroidism: Aforethought on a concealed dilemma.

Subclinical hypothyroidism or mild thyroid failure is a familiar problem, with a prevalence of 3-15% in a population without any known overt thyroid disorder. The prevalence increases with age and is relatively higher among females. Subclinical hypothyroidism is defined as serum thyroid stimulating hormone (TSH) levels above the upper limit of normal (4 mU/L) while the triiodothyronine (T3) and thyroxine (T4) enduring within the normal range. Additionally, there exists a log-linear relationship between TSH and circulating T3 and T4; hence, measurement of serum TSH becomes mandatory for diagnosing mild thyroid failure when free T3and T4 are lying within normal limits. Though, autoimmune thyroid disease is the most common cause for elevated TSH; thyroid functions can be afflicted by long-term consumption of drugs like lithium, amiodarone. The causal relationship between benzodiazepine class of drugs, particularly clonazepam and subclinical hypothyroidism has never been established clinically, yet there are some pre-clinical studies to claim the effect of benzodiazepine on thyroid functions; operating at various levels – hypothalamus, thyroid gland, peripheral cells and nuclear receptors. Henceforth, we would like to report a rare occurrence of subclinical hypothyroidism in an elderly female receiving clonazepam for her underlying psychiatric illness.

Pattern and incidence of adverse drug reactions observed in cardiac clinic of tertiary hospital, Hakeem Abdul Hameed Centenary Hospital, Jamia Hamdard, New Delhi.

Background: The aim of the present study was to monitor the incidence and pattern of adverse drug reactions (ADRs) in cardiac care unit at Hakeem Abdul Hameed (HAH) Centenary Hospital. Methods: Study was conducted with the permission of Institutional Ethics Committee. Patients visiting medicine outpatient department, cardiac clinic, medical ward, and emergency departments over a period of 15 months were recruited. ADRs were recorded on the prescribed form. Causality assessment was done using Naranjo probability scale. 223 patients of hypertension and stable coronary artery disease were enrolled of which 48.9% were males and 51.1% females. The most common prescribed drugs were ace-inhibitors, angiotensin receptor blocker, and beta-blockers. Other prescribed drugs were calcium channel blockers, statins, nitrates, and antiplatelets. Results: A total of 44 ADRs were recorded. 26 ADRs were seen in females and 18 in males. Statins were the commonest drug associated with ADRs (29.5%) in our study. The most common organ system associated with ADRs in the present study was central nervous system followed by skin 15.9% each. The incidence of ADRs was about 20% of which 20% ADRs were probable, and 80% were possible. Maximum ADRs occurred in patients prescribed statins followed by beta-blockers and angiotensin receptor blockers. Conclusion: There is a need for conducting such studies in more and more patients to see the pattern of ADRs in cardiac patients. More information will help in reducing the ADR occurrence and making drug use more rational and safe for patients.

Ciprofloxacin induced erythema multiforme: a case report.

Erythema multiforme (EM) is an acute, self-limited, and sometimes recurring skin condition that is considered to be a type IV hypersensitivity reaction associated with certain infections, medications, and other various triggers like flavorings and preservatives, such as benzoic acid and cinnamon, immunologic disorders, such as transient selective C4 deficiency of infancy, collagen diseases, vasculitides, sarcoidosis, non-Hodgkin lymphoma, leukemia, multiple myeloma, myeloid metaplasia, and polycythemia, physical or mechanical factors, such as tattooing, radiotherapy, cold, and sunlight, foods, including salmon berries and margarine, malignancy, and hormonal. EM may be present within a wide spectrum of severity. EM minor represents a localized eruption of the skin with minimal or no mucosal involvement. According to a consensus definition, Stevens-Johnson syndrome (SJS) was separated from the EM spectrum and added to toxic epidermal necrolysis (TEN). The two spectra are now divided into the following: (1) EM consisting of erythema minor and major and (2) SJS/TEN. Ciprofloxacin is a second generation fluoroquinolone. Fluoroquinolones are rapidly bactericidal in vitro and are considerably potent against Escherichia coli and various species of Salmonella, Shigella, Enterobacter, Campylobacter, and Neisseria. Mainly used in urinary tract infections, prostatitis, sexually transmitted diseases, gastrointestinal and abdominal infections, respiratory tract infections, bone-joint and soft tissue infections. Metronidazole is a nitroimidazole antimicrobial medication used particularly for anaerobic bacteria and protozoa. It is on the World Health Organizations list of essential medicines, a list of the most important medications needed in a basic health system. Here we report the case of a 39-year-old male patient who presented with EM to the dermatology outpatient department, Adichunchanagiri Hospital and Research Centre. The patient gave a history of taking antimicrobials ciprofloxacin and metronidazole for the treatment of a non-healing wound on the right leg which he sustained in a road traffic accident. The review of the literature has revealed very rare associations of metronidazole and pantoprazole with EM, but cases of ciprofloxacininduced EM have been reported. Hence, the reported adverse drug reaction has been attributed to ciprofloxacin. In this event, casualty assessment using Naranjo’s scale revealed that ciprofloxacin was a probable cause for the adverse drug reaction.

Phenytoin/albendazole induced exanthematous eruptions: a case report.

Exanthematous drug eruptions, often called “drug rashes” or “maculopapular eruptions” by non-dermatologists are the most common form of cutaneous drug eruption. Cutaneous reactions are among the most common adverse effects of drugs, including penicillins, cephalosporins, sulfonamides, and allopurinol (with an incidence of up to 50 cases per 1000 new users), and particularly the aromatic amine anti-seizure medications, including carbamazepine, phenytoin, and lamotrigine (with an incidence of up to 100 cases per 1000 new users). Phenytoin is a hydantoin derivative anticonvulsant drug used primarily in the management of complex partial seizures and generalized tonic-clonic seizures. Albendazole is a benzimidazole medication used for the treatment of a variety of parasitic worm infestations. Carbamazepine and phenytoin are among the most common causes of antiepileptic drug-related cutaneous adverse reactions. Manifestations range from a mild erythematous maculopapular rash to life-threatening Stevens-Johnson syndrome and toxic epidermal necrolysis. Albendazole induced rashes and urticaria have been reported in less than 1% of the patients. Here we present the case of a 12-year-old male patient who came to the dermatology outpatient department with complaints of itching and maculopapular eruptions all over the body. The patient gave a history of taking tablet phenytoin and tablet albendazole for neurocysticercosis since 1-week. There was no fever or any other systemic manifestations. There was no history of any other drug intake. A diagnosis of phenytoin/albendazole induced exanthematous eruptions was made. Both the medications were discontinued, and the patient was advised to take syrup sodium valproate 200 mg BD. For the rashes and itching, the patient was advised to take tablet hydroxyzine HCl 10 mg OD, tablet prednisolone and tablet levocetirizine for 5 days. Improvement was seen and the itching reduced. Rechallenge was not done. In this event, casualty assessment using Naranjo adverse drug reaction probability scale revealed that phenytoin/albendazole were probable causes for the adverse drug reaction.

Phenobarbital induced erythroderma: a case report.

Phenobarbital (PHB) (International Non-proprietary Name) or Phenobarbitone (British Approved Name) is a long acting barbiturate and the most widely used antiseizure medication globally. Fever, skin reactions, limb edema, and drug-induced hypersensitivity have been reported in children because of various drugs, mainly aromatic antiepileptic drugs such as phenytoin, PHB, carbamazepine, and primidone. The skin reactions differ in severity and range from a mild maculopapular erythema to exfoliative dermatitis. A 2-month-old male baby was brought to the dermatology out-patient department with complaints of redness and scaling all over the body (erythroderma) after 2-3 weeks of PHB treatment for convulsions. PHB was stopped, and corticosteroids (topical and systemic) were started. The baby improved over a period of 2 weeks. According to Naranjo’s adverse drug reaction probability scale, the causality relation between erythroderma and PHB was found to be a probable one.