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Pulmonary edema is a rare complication occurring after naloxone administration, but the causal relationship remains insufficiently investigated. We aimed to determine the likelihood of naloxone as the causative agent in published cases of pulmonary edema. A literature search was conducted across multiple databases, utilizing database-specific search terms such as "pulmonary edema/chemically induced" and "naloxone/adverse effects." Each case report was evaluated using the Naranjo scale, a standardized causality assessment algorithm. We identified 49 published case reports of pulmonary edema following naloxone administration. The median total dose of naloxone was 0.2 mg for patients presenting following a surgical procedure and 4 mg for out-of-hospital opioid overdoses. Based on the Naranjo scale, the majority of cases were classified as "possible" (n = 38) or "probable" (n = 11) adverse reactions, while no "definite" cases of naloxone-induced pulmonary edema were identified. Many patients were classified as "possible" due to limited patient information or other potential risks, such as fluid administration or airway obstruction. Forty-six of 49 patients survived (94 percent). Pulmonary edema may occur after both low and high doses of naloxone; however, low doses were primarily reported in the surgical population. Despite this complication, the majority of patients survived. Furthermore, no case report in our analysis was classified as a "definite" case of naloxone-induced pulmonary edema which limits the establishment of causality. Future studies should explore patient risk factors, including surgical versus outpatient setting and opioid-naïve versus opioid-tolerant for developing pulmonary edema and employ a causality assessment algorithm. These case reports suggest pulmonary edema can occur following naloxone administration, irrespective of dose. According to the Naranjo scale, there were no definite cases of naloxone-induced pulmonary edema. Overall, we suggest the benefits of naloxone administration outweigh the risks. Naloxone should be administered to treat opioid overdoses while monitoring for the development of pulmonary edema. [ABSTRACT FROM AUTHOR]

Key Clinical Message: Dolutegravir, the most recent antiretroviral drug with high efficacy, good tolerability, infrequent drug–drug interactions, and a favorable safety profile has not been reported in current literature as a cause of acquired sideroblastic anemia. Here, we present a 35‐year‐old male patient who was diagnosed with acquired sideroblastic anemia to Dolutegravir therapy. [ABSTRACT FROM AUTHOR]

Vincristine (VCR) as a key drug for the treatment of acute lymphoblastic leukemia (ALL) is associated with neurotoxicity. We present a young man with a history of controlled childhood seizures who was diagnosed with pre-B-cell ALL and developed generalized tonic-clonic seizures following the Cancer and Leukemia Group B (CALGB) 8811 regimen. The patient also received oral itraconazole to prevent fungal infection initiated by chemotherapy. Possible causes of seizure, including electrolyte abnormalities, hypoglycemia, central nervous system infection or inflammation, were ruled out. According to the Naranjo Adverse Drug Reaction Scale, the patient’s seizure had been attributed to VCR, possibly secondary to concomitant use of itraconazole and doxorubicin. The patient successfully recovered after discontinuation of VCR and supportive care. Clinicians should be aware of the possibility of vincristine-induced seizure in adult patients, especially with the concomitant use of drugs known to have potential drug-drug interactions.

Key Clinical Message Dolutegravir, the most recent antiretroviral drug with high efficacy, good tolerability, infrequent drug–drug interactions, and a favorable safety profile has not been reported in current literature as a cause of acquired sideroblastic anemia. Here, we present a 35‐year‐old male patient who was diagnosed with acquired sideroblastic anemia to Dolutegravir therapy.

A severe medical condition known as Stevens-Johnson syndrome (SJS) is marked by a cutaneous and mucosal reaction from the use of specific medications. The prodromal illness is followed by severe mucocutaneous symptoms in this immune-mediated disease. We describe the clinical history of a 55-year-old Caucasian woman who was exposed to cephalosporins. In resource-constrained countries and hospitals where cutaneous biopsy is not readily available, it is not easy to diagnose Steven Johnson Syndrome. This is particularly true in countries where the incidence of infectious diseases such as scarlet fever and measles is high and the early symptoms of SJS can be mistaken for these conditions. We used the Naronjo scale to confirm the probable association of the drug with the syndrome. Physicians while writing prescriptions for their patients need to warn them of potential side effects and they should keep in mind conditions like Stevens-Johnson syndrome. This case report highlights the need for improved knowledge and understanding of SJS among healthcare practitioners in resource-limited communities where the prevalence of infectious diseases is high. [ABSTRACT FROM AUTHOR]

Background & Objective: Breast cancer (BC) is the leading cause of cancer mortality among women in different countries around the world, including India. Monoclonal antibodies (MoAbs) have emerged as a promising targeted treatment for BC, improving the survival rate of these patients with minimum adverse effects. This study aimed to investigate the severity of the adverse effects of MoAbs in an Indian population. Materials & Methods: This longitudinal descriptive study was conducted on 120 BC patients over six months in a tertiary care hospital in Bangalore, India, in 2020. A data collection form was used to gather relevant data. The collected data were analyzed by SPSS Version 21, using Chi-square and Fisher’s exact tests. A P-value less than 0.05 was considered statistically significant. Results: Among 97 patients evaluated in this study (including 29 patients in the nonexposed group), the adverse effects of BC were observed in all age groups. Most adverse effects were attributed to trastuzumab (37.50%; CI: 31.6-44) and bevacizumab (26.78%; CI: 20.9-31.8). The MoAbs were well tolerated by the patients, causing minimum adverse effects that were manageable by supportive therapy. Anemia was the most prevalent adverse effect. Evaluation of the null hypothesis indicated that the adverse effects of MoAbs depended on their amount and composition. The results of analysis using the Naranjo scale revealed that most of the adverse effects were probable (67%) and possible (32%), respectively. Also, according to the WHO scale, most of the adverse effects were under the categories of probable (61.20%) and possible (38.14%), respectively. Conclusion: Based on the present results, the adverse effects of MoAbs were manageable by supportive care. Anemia was found to be the most prevalent adverse effect. Meanwhile, no potential adverse cardiovascular event was observed in patients on trastuzumab, except one case of dilated cardiomyopathy. [ABSTRACT FROM AUTHOR]

Background: Few Saudi studies have examined adverse drug reactions (ADRs) in patients with rheumatoid arthritis (RA) receiving intravenous (IV) originator biologics. Therefore, this study aimed to evaluate the prevalence, types, and predictors of ADRs following long-term IV originator biologic use in patients with RA. Patients and methods: This retrospective, single-center study included adult patients with RA who received IV originator biologics between 2015 and 2020. Medical records were reviewed and data regarding ADRs were collected and evaluated for causality using the Naranjo scale. Binary logistic regression analysis was performed to identify the odds for and factors associated with developing ADRs for each biologic. Results: A total of 129 patients (87.6% women) with a mean (standard deviation) age of 54 (13) years were included in this study. A total of 1963 doses of tocilizumab (38.76%), rituximab (38.76%), abatacept (13.95%), and infliximab (8.53%), were administered during the study period. ADRs with a Naranjo score ≥ 1 were experienced by 103 (78%) patients, with an average of 2.2 events per patient. Infection (26.6%) and skin and mucous membrane disorders (14.18%) were the most commonly reported ADRs. Abatacept was associated with a significantly higher risk of multiple ADRs than the other biologics (adjusted odds ratio: 3.145, 95% confidence interval 1.004–9.854, p = 0.049). Conclusion: There was a high prevalence of ADRs among patients with RA receiving biologics. Abatacept was associated with a greater risk of multiple ADRs than other biologics. Infection was the most common ADR. Future multicenter longitudinal studies are warranted.

Purpose: This study aimed to assess the type, severity, seriousness, reasons, and outcomes of adverse drug reactions (ADRs) in the reports submitted to the regional spontaneous ADR database. Methods: A retrospective observational study was conducted to analyze all the Tabuk Health Affairs hospitals in Saudi Arabia submitted to SFDA from January 2020 to December 2020. The database was structured according to the Saudi ADR form’s fields. The Naranjo algorithm was used to assess the causes of the ADRs (sFDA, 2022). Results: For 1 year, 2,349 ADR reports, along with 242 suspected drugs for 4,114 reactions, were submitted to SFDA. We found more males than females had ADRs (56.1% vs. 43.8%, P

Vincristine (VCR) as a key drug for the treatment of acute lymphoblastic leukemia (ALL) is associated with neurotoxicity. We present a young man with a history of controlled childhood seizures who was diagnosed with pre-B-cell ALL and developed generalized tonic-clonic seizures following the Cancer and Leukemia Group B (CALGB) 8811 regimen. The patient also received oral itraconazole to prevent fungal infection initiated by chemotherapy. Possible causes of seizure, including electrolyte abnormalities, hypoglycemia, central nervous system infection or inflammation, were ruled out. According to the Naranjo Adverse Drug Reaction Scale, the patient's seizure had been attributed to VCR, possibly secondary to concomitant use of itraconazole and doxorubicin. The patient successfully recovered after discontinuation of VCR and supportive care. Clinicians should be aware of the possibility of vincristine-induced seizure in adult patients, especially with the concomitant use of drugs known to have potential drug-drug interactions. [ABSTRACT FROM AUTHOR]

Aim: An observational study to find out rationality of polypharmacy in geriatric medicine OPD in tertiary care hospital. Material and methods: Patient with age of 65 years and above fulfilling the inclusion criteria was enrolled after written informed consent. 171 patients were included in this study. Prescription of patient enrolled was be noted down in a paper to be retain for further analyses in case record form. These increases was categories into various category required for application of beer's and STOPP/START criteria. Every visit was be utilized for detail prescription (change if any) and find ADR. Patient was be given telephone number to primary investigator observe reported ADR since beginning further detailed information regarding any ADR was be taken out to be analysed by using Naranjo Scale and Hartwig's Severity scale. Results: The frequency distribution of age intervals of the study subjects. 88.9% patients were in the age range of 65-75 years, 10.5% in 76-85 years and 0.6% in the age range of more than 85 years. Mean age was 69.15±4.82 years with median of 67 years. It is observed that 737% were make and 26.3% were females. Polypharmacy present includes subjects as 63% not definitely inappropriate and 37% potentially inappropriate. Polypharmacy present includes subjects as 73.7% START, 26.3% STOPP. 79.3% were possible and 20.97% were probable. [83.9 %] were Level - 1 and [16.1%] were level -3. Total 62 ADR were reported in which 22 patients were taking potential inappropriate medication, but this association is insignificant. In polypharmacy present, 61.3% were present and 63.6% were absent. The association was not significant and p value in 0.812. Conclusion: We concluded that the AGS Beers Criteria in clinical practise in the geriatric population should inspire the prescribers. Strict measures should be adopted to implement medical reconciliation practises in centres caring for older patients with numerous comorbidities because the problem of polypharmacy and potentially inappropriate treatment is rising in developing countries. [ABSTRACT FROM AUTHOR]

Ciprofloxacin, among the many Fluoroquinolones, has been widely used as a broad‐spectrum antibiotic due to its wide range of action and relatively safe adverse effect profile. However, among the cutaneous adverse drug reactions due to Ciprofloxacin, toxic epidermal necrolysis occurring along with cholestatic hepatitis is a rare one. Here, we present a case of a 22‐year‐old male patient who was diagnosed with toxic epidermal necrolysis with cholestatic hepatitis secondary to Ciprofloxacin. Naranjo adverse drug reaction probability scale was used for the causal association. [ABSTRACT FROM AUTHOR]

Study aim to describe the spontaneous reporting of the adverse drug reactions (ADRs) among the patients admitted to medicine department of a tertiary care hospital. A prospective observational study was conducted over a period of four months at the medicine department. On the daily basis, all the patients aged >18 years admitted to the internal medicine department were followed and analyzed for occurrence of ADRs. Naranjo scale was used to determine causal relationship between the ADRs and suspected drugs. The nature of ADRs and its severity was assessed using the Hartwig scale. A total of 4,530 patients were screened for the ADRs, out of which 90 ADRs were developed in the 89 patients. The overall incidence of ADRs was found to be 1.96% in the studied population. The most common ADRs encountered during the study period were type A (augmented). The least number of ADRs were observed in the age group of 31–40 years. Furthermore, the more significant number of male patients suffered from a severe type of ADRs as compared to females. Sixteen ADRs were of the mucocutaneous type of reaction followed by dizziness in 12 cases. The higher number of patients recovering from the ADRs was in the age group 41–60 years. The outcomes of ADRs were not found to be statistically significant with gender and age groups. There is a strong need to extend the monitoring and reporting of the ADRs to ensure the patient safety. However, the overall incidence of ADRs appeared to be less in our study, highlighting the need for strengthening reporting system of ADRs. The results indicate that elderly patients are at significant risk of developing ADRs. [ABSTRACT FROM AUTHOR]

Background: Contradictory studies reporting vast heterogeneity in the teicoplanin-induced thrombocytopenia (TIT) incidence exist. Objective: To identify the incidence of TIT associated with teicoplanin dosing range (6-12 mg/kg/dose) and the risk factors of TIT. Methods: This retrospective observational study included adult patients who received teicoplanin for =3 consecutive days over a period of 3.5 years. Thrombocytopenia was defined as a platelet count of <100 × 10³/µL coupled with at least a 25% drop from the baseline count. The TIT incidence was assessed using the adverse drug reaction probability scale (Naranjo scale). Results: Data from 482 patients who received teicoplanin and met the predefined inclusion criteria were included in the analyses. The cohort presented a mean age of 53.5 ± 19 years, where 72.4% were male, and 49.2% exhibited normal baseline renal function. Teicoplanin was most commonly used for bacteremia (n = 134), and the most common isolated pathogen being Staphylococcus aureus (n = 221). The TIT incidence was 4.6% (the possible and probable category using the Naranjo scale; 22/482). The median time to first platelet count dropped to <100 × 10³/µL after teicoplanin initiation was 5 (interquartile range [IQR], 3-10) days and 8 (IQR, 5-14) days till the maximum platelet count dropped. None of the tested patient variables were found to be independently associated with an increased risk of thrombocytopenia. Conclusion and Relevance: The overall TIT incidence was low across our study cohort, including critically ill patients. Our study results may aid in the optimal monitoring of such serious teicoplanin-induced adverse effects. [ABSTRACT FROM AUTHOR]

Majed Al Jeraisy,1,2 Shaden Al Osaimi,1 Abdullah Al Hawas,1 Alanoud Muamar,1 Lamia Aleidi,3 Njoud Khonain,4 Mostafa A Abolfotouh2 1College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia; 2King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia; 3Unaizah College of Pharmacy, Qassim University, Riyadh, Saudi Arabia; 4College of Pharmacy, Princess Noura Bint Abdulrahman University, Riyadh, Saudi ArabiaCorrespondence: Mostafa A AbolfotouhKing Abdullah International Medical Research Center (KAIMRC)/King Saud bin-Abdulaziz University for Health Sciences (KSAU-HS), Ministry of National Guard- Health Affairs, P.O. Box 3660, Riyadh, 11426, Saudi ArabiaTel +966 11 429-4460; +966 503659204Fax +966 11 429-4440Email mabolfotouh@gmail.comBackground: Patients allergic to antibiotics are at higher risk of receiving treatment with a broader spectrum, more harmful, and expensive agents. The aims of this study were (1) to assess the quality of documentation of antibiotics allergies in the electronic medical records (EMR) in a Pediatric tertiary care setting, and (2) to determine the validity of physicians’ decision to hold antibiotics prescriptions.Methods: This is a retrospective cohort study at King Abdullah Specialized Children Hospital, Riyadh, Saudi Arabia. A review of the EMR and all Adverse Drug Reaction (ADR) reports of pediatric patients 1– 14 years old, with a documented allergy to antibiotics from June 2016 until June 2019. The quality of documentation of antibiotics allergy was assessed based on the presence of four parameters: 1) allergy alert notification, 2) allergy severity classification, 3) setting notes, and 4) symptoms’ description. In addition, all physicians’ reports of allergy to antibiotics were cross-classified according to their corresponding ADR reports, and the validity of physicians’ documentation of allergy was assessed.Results: Of a total of 105 Pediatric patients’ EMR, documentation of antibiotics allergy was available in 98 (93.3%), with the presence of symptoms description (83%), allergy notes (87%), severity (67%), and signs of alert (50.8%). Overall documentation quality was good for only 23.5% of patients, while it was poor for 35.7%. Physicians’ documentation of antibiotics allergy was 0.82 sensitive [with 0.18 risk of allergy] and 0.60 specific [with 0.40 unnecessary restrictions of prescriptions]. Of all children with possible/actual allergies, only 38.9% were referred to the immunology clinic.Conclusion: The quality of documentation of antibiotic allergy in children and the validity of physicians’ decisions are less than satisfactory. Therefore, improving communications between all healthcare providers regarding patients’ allergy status and follow-up for further assessment of the reaction is recommended to improve patient care.Keywords: flagging, drug allergy, allergy documentation, quality, Naranjo scale

Abstract Ciprofloxacin, among the many Fluoroquinolones, has been widely used as a broad‐spectrum antibiotic due to its wide range of action and relatively safe adverse effect profile. However, among the cutaneous adverse drug reactions due to Ciprofloxacin, toxic epidermal necrolysis occurring along with cholestatic hepatitis is a rare one. Here, we present a case of a 22‐year‐old male patient who was diagnosed with toxic epidermal necrolysis with cholestatic hepatitis secondary to Ciprofloxacin. Naranjo adverse drug reaction probability scale was used for the causal association.

Abstract Background Alemtuzumab is a T cell depleting antibody agent used as induction immunosuppressant therapy in solid organ transplant recipients. In addition, it is being increasingly used to treat severe or glucocorticoid-resistant graft rejection. Despite the effectiveness of the treatment, severe adverse events have been reported related to alemtuzumab administration. We present a similar event illustrating the severity of this adverse drug reaction (ADR) and we highlight the structure causality assessment provides in approaching such a case. Case presentation We report a case of life-threatening respiratory failure after alemtuzumab administration in a 17 year old paediatric kidney transplant recipient. He developed near fatal severe respiratory and circulatory failure based on acute respiratory distress syndrome (ARDS) with diffuse alveolar oedema and haemoptysis hours after his second alemtuzumab administration. As it was questionable whether alemtuzumab could be regarded as the origin of his reaction and in order to assess the causality of this reaction as well as to structure clinical reasoning, we applied a widely used ADR probability scale to systematically review our case. Discussion and conclusions Our case shows a severe ADR after alemtuzumab administration. It illustrates the importance of proper causality assessment, the structure it provides and the benefit of a clinical pharmacology consultation when a severe reaction is suspected to be an ADR. By taking our case as an example, we demonstrate the added value of structured causality assessment to clinical reasoning and in generating differential diagnoses.

Few Saudi studies have examined adverse drug reactions (ADRs) in patients with rheumatoid arthritis (RA) receiving intravenous (IV) originator biologics. Therefore, this study aimed to evaluate the prevalence, types, and predictors of ADRs following long-term IV originator biologic use in patients with RA. This retrospective, single-center study included adult patients with RA who received IV originator biologics between 2015 and 2020. Medical records were reviewed and data regarding ADRs were collected and evaluated for causality using the Naranjo scale. Binary logistic regression analysis was performed to identify the odds for and factors associated with developing ADRs for each biologic. A total of 129 patients (87.6% women) with a mean (standard deviation) age of 54 (13) years were included in this study. A total of 1963 doses of tocilizumab (38.76%), rituximab (38.76%), abatacept (13.95%), and infliximab (8.53%), were administered during the study period. ADRs with a Naranjo score ≥ 1 were experienced by 103 (78%) patients, with an average of 2.2 events per patient. Infection (26.6%) and skin and mucous membrane disorders (14.18%) were the most commonly reported ADRs. Abatacept was associated with a significantly higher risk of multiple ADRs than the other biologics (adjusted odds ratio: 3.145, 95% confidence interval 1.004–9.854, p = 0.049). There was a high prevalence of ADRs among patients with RA receiving biologics. Abatacept was associated with a greater risk of multiple ADRs than other biologics. Infection was the most common ADR. Future multicenter longitudinal studies are warranted. [ABSTRACT FROM AUTHOR]

This study aimed to assess the type, severity, seriousness, reasons, and outcomes of adverse drug reactions (ADRs) in the reports submitted to the regional spontaneous ADR database. A retrospective observational study was conducted to analyze all the Tabuk Health Affairs hospitals in Saudi Arabia submitted to SFDA from January 2020 to December 2020. The database was structured according to the Saudi ADR form's fields. The Naranjo algorithm was used to assess the causes of the ADRs (sFDA, 2022). For 1 year, 2,349 ADR reports, along with 242 suspected drugs for 4,114 reactions, were submitted to SFDA. We found more males than females had ADRs (56.1% vs. 43.8%, P < 0.05). Antimicrobial drugs (26.9%), hematologic drugs (19.7%), and neuropsychiatric drugs (12.9%) were responsible for most ADRs. Most of the reactions were associated with the use of ciprofloxacin (7.7%), followed by the combination of lopinavir and ritonavir (4.1%). Two deaths resulted from salbutamol and cefazolin use. Based on the results of the Naranjo assessment of causality, cardiovascular events (9.9%) exhibited the highest score (≥9) for a causal relationship with the suspected drugs, followed by dermatological events (9.5%). The spontaneous report database is an important and valuable source of aftermarket authorization safety information. In our study, most drugs used as antimicrobial, cardiovascular, and hematologic therapies were associated with a higher risk of developing severe and serious events. We recommend monitoring and using medications optimally to ensure patient safety. [ABSTRACT FROM AUTHOR]

Objective: Benzodiazepines have been reported to cause photosensitivity reactions. We characterized the clinical presentation and diagnosis of benzodiazepine‐associated photosensitivity and adjudicated these cases for a causal association with benzodiazepines. Methods: A literature search on PubMed's "MeSH" search feature and CINAHL (1964 to 2019) was performed using search terms: benzodiazepine, photosensitivity, and photosensitivity disorders/chemically induced. We applied the Naranjo scale, a standardized causality assessment algorithm, to identified cases. Results: We identified eight published cases, with 50% of patients being female with a mean age of 46.3 years. Alprazolam, tetrazepam, clobazam, and clorazepate induced phototoxic reactions. Chlordiazepoxide induced one photoallergic reaction. Photosensitivity occurred between 1‐3 days (37.5%), 7‐14 days (25%), and >14 days (25%). Photosensitivity resolved after drug discontinuation within 2 weeks (62.5%). Benzodiazepine rechallenge confirmed photosensitivity in 75% of cases. Photopatch testing was negative in two patients; however, these patients had positive oral provocation testing. However, an oral photoprovocation test, an ideal diagnostic test, was not administered to several patients. Despite these challenges, the Naranjo scale identified 5 cases as definite benzodiazepine‐induced photosensitivity. Conclusion: Five benzodiazepines induced photosensitivity reactions. Five patients showed a definite association with the Naranjo scale. Reporting to pharmacovigilance databases may help identify other benzodiazepines causing photosensitivity reactions. [ABSTRACT FROM AUTHOR]

aimi,1 Abdullah Al Hawas,1 Alanoud Muamar,1 Lamia Aleidi,3 Njoud Khonain,4 Mostafa A Abolfotouh21College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia; 2King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia; 3Unaizah College of Pharmacy, Qassim University, Riyadh, Saudi Arabia; 4College of Pharmacy, Princess Noura Bint Abdulrahman University, Riyadh, Saudi ArabiaCorrespondence: Mostafa A AbolfotouhKing Abdullah International Medical Research Center (KAIMRC)/King Saud bin-Abdulaziz University for Health Sciences (KSAU-HS), Ministry of National Guard- Health Affairs, P.O. Box 3660, Riyadh, 11426, Saudi ArabiaTel +966 11 429-4460; +966 503659204Fax +966 11 429-4440Email [email protected] Background: Patients allergic to antibiotics are at higher risk of receiving treatment with a broader spectrum, more harmful, and expensive agents. The aims of this study were (1) to assess the quality of documentation of antibiotics allergies in the electronic medical records (EMR) in a Pediatric tertiary care setting, and (2) to determine the validity of physicians' decision to hold antibiotics prescriptions. Methods: This is a retrospective cohort study at King Abdullah Specialized Children Hospital, Riyadh, Saudi Arabia. A review of the EMR and all Adverse Drug Reaction (ADR) reports of pediatric patients 1– 14 years old, with a documented allergy to antibiotics from June 2016 until June 2019. The quality of documentation of antibiotics allergy was assessed based on the presence of four parameters: 1) allergy alert notification, 2) allergy severity classification, 3) setting notes, and 4) symptoms' description. In addition, all physicians' reports of allergy to antibiotics were cross-classified according to their corresponding ADR reports, and the validity of physicians' documentation of allergy was assessed. Results: Of a total of 105 Pediatric patients' EMR, documentation of antibiotics allergy was available in 98 (93.3%), with the presence of symptoms description (83%), allergy notes (87%), severity (67%), and signs of alert (50.8%). Overall documentation quality was good for only 23.5% of patients, while it was poor for 35.7%. Physicians' documentation of antibiotics allergy was 0.82 sensitive [with 0.18 risk of allergy] and 0.60 specific [with 0.40 unnecessary restrictions of prescriptions]. Of all children with possible/actual allergies, only 38.9% were referred to the immunology clinic. Conclusion: The quality of documentation of antibiotic allergy in children and the validity of physicians' decisions are less than satisfactory. Therefore, improving communications between all healthcare providers regarding patients' allergy status and follow-up for further assessment of the reaction is recommended to improve patient care. [ABSTRACT FROM AUTHOR]

Background: Alemtuzumab is a T cell depleting antibody agent used as induction immunosuppressant therapy in solid organ transplant recipients. In addition, it is being increasingly used to treat severe or glucocorticoid-resistant graft rejection. Despite the effectiveness of the treatment, severe adverse events have been reported related to alemtuzumab administration. We present a similar event illustrating the severity of this adverse drug reaction (ADR) and we highlight the structure causality assessment provides in approaching such a case.Case Presentation: We report a case of life-threatening respiratory failure after alemtuzumab administration in a 17 year old paediatric kidney transplant recipient. He developed near fatal severe respiratory and circulatory failure based on acute respiratory distress syndrome (ARDS) with diffuse alveolar oedema and haemoptysis hours after his second alemtuzumab administration. As it was questionable whether alemtuzumab could be regarded as the origin of his reaction and in order to assess the causality of this reaction as well as to structure clinical reasoning, we applied a widely used ADR probability scale to systematically review our case.Discussion and Conclusions: Our case shows a severe ADR after alemtuzumab administration. It illustrates the importance of proper causality assessment, the structure it provides and the benefit of a clinical pharmacology consultation when a severe reaction is suspected to be an ADR. By taking our case as an example, we demonstrate the added value of structured causality assessment to clinical reasoning and in generating differential diagnoses. [ABSTRACT FROM AUTHOR]

Aim: The aim was to study the pattern of adverse drug reaction (ADR) provoked by anticancer therapy and to assess the quality of life (QoL) in cancer patients.Materials and Methods: This study was conducted in Tamil Nadu on 75 patients from February to July 2019 taking into account their demographic profile, ADR occurrence and its causality, outcome, organ system-wise distribution of ADRs, and others. The causality assessment was done by using Naranjo's scale and QoL was assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) scale. The QoL was compared in any two consecutive cycles between the 2nd and 5th cycles of chemotherapy.Results: Out of the 75 patients, 17 male and 56 female patients developed ADR. A total of 228 ADRs were observed in 73 patients. The most commonly occurred ADR was nausea and vomiting (45%) and the most commonly affected system was gastrointestinal tract (37%). According to causality assessment, the ADR that occurred falls mostly in the category of probable (66.7%) followed by possible (29.3%) and the outcome of the ADR was mostly recovering (49.3%). The QoL was higher in females and in the age group of 40-49 years. The physical and emotional well-being of the patient were affected more. The overall QoL was improved in the 2nd visit when compared to the 1st visit.Conclusion: Cancer is known to cause a significant impact on the health and socioeconomics of a nation. To boost the QoL in patients, it is essential to identify and manage the ADRs by taking appropriate measures to promote judicious use of drugs. [ABSTRACT FROM AUTHOR]

Introduction: Adverse drug reaction is defined by WHO as any response to a drug which is noxious and unintended, and which occurs at doses used in man for the prophylaxis, diagnosis or therapy of disease or for the modification of physiological function. Material and Methods: It was comparative, prospective and cohort study. The study was conducted at SMBT Medical Institute and Research Centre Dhamangaon Nashik and private Diabetic clinic. Group A: SMBT Medical Institute and Research Centre Dhamangaon Nashik. Group B: Private Diabetic clinic. All suspected ADRs were initially assessed by the Consultant Incharge - Diabetes Clinic and subsequently the information was collected and analyzed by the pharmacologists for causality assessment. Result: All the reported ADRs i.e. 22 (100%) were of type A reactions which are predictable. On the other hand, in Private clinic, a total of 18 patients of various age groups, belonging to either gender suffered from the adverse drug reactions. Among them, 17 (94.4%) cases were of type A reactions which are predictable. Only 1 (5.55%) suffered from Type B reaction. During the study period, 22 cases of adverse drug reactions were reported in Tertiary care hospital, out of which all (100 %) were of predictable type. The most commonly occurring ADR were hypoglycaemia was the most common ADR observed accountable 8 (36.3%). The most commonly occurring ADRs were hypoglycaemia was the most common ADR observed accountable 7 (38.8%) followed by Abdominal pain, Dizziness, Pedal edema. The percentages of other adverse drug reactions were comparatively less in Group B. Conclusion: ADRs are drug related problems which is considered as important drawback for drug safety. The spontaneous reporting used in study allowed the detection and characterization of ADRs. [ABSTRACT FROM AUTHOR]

The most reported form of statin induced pain is myalgia, conversely peripheral neuropathy is a rare side effect. We report a patient who received rosuvastatin for hypercholesterolemia and experienced episodes of pain in both hands during the night. Rosuvastatin was stopped and atorvastatin was replaced. Re-introduction with another statin resulted in a more severe form of the similar adverse effect after 4 months. This is a rare adverse effect of a extensively prescribed class of drug. Physicians should be aware of the possibility of peripheral neuropathy symptoms in patients on statin therapy.

Background Cutaneous adverse drug reactions (ADRs) are among the most frequent ADRs. Knowledge of the pattern of cutaneous ADRs (CADRs) and causal drugs helps prevent and reduce the incidence of CADR, which in turn reduces the incidence of hospitalization and expenses for the patient. Objectives To analyze CADR according to demographic profile, morphological pattern, causative drugs, severity, and outcome in patients suffering from CADRs. Materials and methods Retrospective data analysis was conducted in the Adverse Drug Reaction Monitoring Centre (AMC) of the tertiary care teaching institute between February 2020 and September 2023 under the Pharmacovigilance Program of India (PvPI). All ADRs reported were analyzed based on the following parameters: total number of ADRs reported, number of CADRs, information related to demographic parameters, the clinical presentation of CADRs, and suspected medication. Causality assessment was done using the World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) scale. Severity was assessed using a modified Hartwig and Seigel scale. Results A total of 125 CADRs were analyzed. Considering the gender-wise distribution, 65 females and 60 males suffered from CADR. The most common drug category responsible for CADRs was antimicrobials (63.2%), followed by topical agents (12.8%). Maculopapular rash (33.6%) was the most common presenting symptom, followed by itching (27.2%). Few patients suffered from serious CADRs such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).  Conclusion A wide clinical spectrum of CADRs ranging from maculopapular rash to fixed-drug eruption to serious SJS was observed in our study. The most common causative agents for CADRs were antimicrobials, followed by topical agents and NSAIDs. For early diagnosis and management of CADRs, it is critical to have data on the potential cutaneous adverse effects of commonly used drugs, to educate the patients regarding common early symptoms of drug reactions (e.g., erythematous rash, edema, urticaria, mucosal erosions, itching, burning of skin, etc.), and to monitor the patient, especially during the start of therapy. To ease the burden of CADRs, a therapeutic plan of anticipating, avoiding, recognizing, and responding to ADRs should be implemented., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2024, Chindhalore et al.)

The article presents the case of 40-year-old who was presented to a male medical ward of a tertiary care teaching hospital due to swelling of lower limbs, breathlessness, facial puffiness, and reduced urine output to discuss an extensive fixed drug eruption (FDE) because of adverse drug reaction to furosemide. His furosemide treatment was discontinued and was replaced with steroids.

Context: Adverse drug reactions (ADR) due to antipsychotic therapy have significant impact on a psychiatric patient's quality of life. Few studies have been conducted in India to monitor adverse drug reactions due to antispsychotics and none has been done to determine their impact on quality of life. Aims: The present study was conducted to monitor ADRs due to antipsychotics and ascertain the impact of ADRs on quality of life. Settings and Design: This prospective observational study was conducted in the psychiatry outpatients department in New Delhi for 1 year. Patients and Methods: A total of 224 patients enrolled were followed up for a period of 3 months. ADRs were monitored using the standard form of the Central Drugs Standard Control Organization and causality was determined using the Naranjo algorithm. The WHO Quality of Life BREF (WHOQOL-BREF) scale was used to study the effect of ADR on the quality of life. Statistical Analysis Used: The data were entered and analyzed using the statistical software SPSS 17.0. Unpaired t-test was used to compare the quality of life of patients who encountered ADRs and those who did not. P < 0.05 was considered statistically significant. Results: Of the total 224 patients, 38 adverse drug events occurred. Adverse drug events were mostly with risperidone (10), followed by olanzapine (8) owing to high usage. Majority of the events were classified as probable (34). The occurrence of adverse drug events decreased the scores on physical and psychological domain scores of WHO-QOL BREF at 3 months compared to baseline. Conclusions: The study provides information on the existing incidence of ADRs in the setup with an established pharmacovigilance center. The nature of ADRs correlates with the prevalence pattern of usage of atypical antipsychotics. Clinicians need to weigh benefit versus the impact on quality of life while prescribing antipsychotics.

Introduction: Adverse drug reactions (ADRs) are unavoidable and are considered as the fourth-to-sixth leading causes of death. It makes it essential to detect and monitor the ADRs. Hence, this study was aimed to identify the agents involved in the occurrence of ADRs and to identify and monitor the ADRs occurred in inpatients of a tertiary care hospital. Materials and Methods: It was a descriptive, prospective, observational study conducted for 2 years at a tertiary care hospital in Bengaluru, India. The ADRs were detected and monitored by interviewing the patients and reviewing the laboratory tests and medical charts. All the collected data were tabulated in Microsoft Excel 2016 and analyzed for possible results. Using Naranjo scale and Hartwig and Seigel's severity assessment scale, the probability and severity of the reactions have been identified. Results: In this study, it was observed that majority of ADRs occurred in females. Patients belonging to the age group of 21-50 years old experienced higher number of ADRs than the patients in other age groups. The most commonly reported ADRs were associated with antimicrobial and cardiovascular agents. The most commonly reported ADRs were elevated liver function test (LFT) (12.2%) followed by diarrhea (9.5%). The gastrointestinal system was the most commonly affected organ system followed by fluid and electrolytes. Majority of the ADRs (55.1%) were found to be probable. In addition, the majority of the reported ADRs (84.2%) were mild. Conclusion: The results of this study provide a database of ADRs, which aids clinicians in optimized and safer use of medicines and this, in turn, might lead to an enhanced level of patient care. [ABSTRACT FROM AUTHOR]

Aim: The aim was to study various morphological patterns of cutaneous adverse drug reactions (CADRs) and identify the culprit drug or drugs by establishing a causal link using Naranjo adverse drug reaction probability scale. Materials and Methods: The study was carried out between November 2010 and November 2011 at the Department of Dermatology, Government Medical College, Jammu. A total of 150 patients with CADR reporting to the dermatology department or referred from other departments were evaluated. Detailed history, clinical examination, hematological, and biochemical investigations were recorded. The venereal disease research laboratory test, HIV (ELISA), and histopathological examination were done wherever indicated. Results: A total of 150 patients were evaluated after applying the inclusion and exclusion criteria. The mean age of the patients with CADRs was 33.26 years. A majority of patients (30.6%) were in the age group of 21-30 years. The male to female ratio was 1.7:1.2. The most common CADRs were fixed drug eruption in 33.3% of patients followed by urticaria in 17.3%, and maculopapular rash in 13.3%. The most common classes of drugs implicated were antimicrobials in 40% of patients followed by nonsteroidal antiinflammatory drugs in 35.3%. The Naranjo adverse drug reaction probability scale indicated probable association of 77.3%, highly probable association of 12.6%, and 1% possible association with the implicated drugs. Conclusion: The pattern of CADRs and the drugs causing them is remarkably different in our population. Knowledge of these drug reactions, their causative drugs, and prognostic indicators is essential for the clinician.

Context: Adverse drug reactions (ADR) due to antipsychotic therapy have significant impact on a psychiatric patient's quality of life. Few studies have been conducted in India to monitor adverse drug reactions due to antispsychotics and none has been done to determine their impact on quality of life. Aims: The present study was conducted to monitor ADRs due to antipsychotics and ascertain the impact of ADRs on quality of life. Settings and Design: This prospective observational study was conducted in the psychiatry outpatients department in New Delhi for 1 year. Patients and Methods: A total of 224 patients enrolled were followed up for a period of 3 months. ADRs were monitored using the standard form of the Central Drugs Standard Control Organization and causality was determined using the Naranjo algorithm. The WHO Quality of Life BREF (WHOQOL-BREF) scale was used to study the effect of ADR on the quality of life. Statistical Analysis Used: The data were entered and analyzed using the statistical software SPSS 17.0. Unpaired t-test was used to compare the quality of life of patients who encountered ADRs and those who did not. P < 0.05 was considered statistically significant. Results: Of the total 224 patients, 38 adverse drug events occurred. Adverse drug events were mostly with risperidone (10), followed by olanzapine (8) owing to high usage. Majority of the events were classified as probable (34). The occurrence of adverse drug events decreased the scores on physical and psychological domain scores of WHO-QOL BREF at 3 months compared to baseline. Conclusions: The study provides information on the existing incidence of ADRs in the setup with an established pharmacovigilance center. The nature of ADRs correlates with the prevalence pattern of usage of atypical antipsychotics. Clinicians need to weigh benefit versus the impact on quality of life while prescribing antipsychotics. [ABSTRACT FROM AUTHOR]