Search

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]

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.

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]

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.)

Introduction:  Adverse drug reactions (ADR) are caused by a wide range of drugs including antibiotics. Currently, the prevalence and pattern of antibiotic-related ADR in Saudi Arabia are not well reported. The present study aimed to evaluate the ADR pattern caused by antibiotics in a tertiary healthcare center., Methods: This was a retrospective study conducted on 85 patients admitted to tertiary care hospital medical wards during the period from 2015 to 2019. The following data such as patient demographics (age, gender, weight, height), reason for admission, number of antibiotics use, comorbid condition, antibiotic(s) involved in ADR, classification of ADR, and type of ADR were recorded. Naranjo's scale was used to measure the probability of ADR., Results: Among the 85 patients, the most frequent type of antibiotic was cephalosporins in 36.47%, followed by penicillins in 31.76% of the patients. The major type of ADR was rash (52.95%), followed by anaphylaxis reactions (10.59%) of the patients. Based on the Naranjo scale, the ADR was possible in 80% and probable in 18.82% of the cases. The presence of medical conditions displayed a significant association with the development of rashes (p=0.03). In addition, the female gender (p=0.009) and the presence of medical conditions (p=0.03) showed significant association with the development of anaphylaxis., Conclusion: Cephalosporin and penicillins were the most common antibiotics responsible for ADR, and the rash was the most common ADR., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Ahmed Bakri et al.)

Background: Cutaneous Adverse Drug Reactions (ADRs) are common and pose a serious challenge to physicians, especially in cases when the patient has many comorbidities, is polypharmacy, or self-administers over-the-counter medications., Objective: The objective of this study is to analyze the clinical pattern and incidence of cutaneous ADRs and perform causality assessment using the WHO-UMC scale and Naranjo's scale. The severity of the reactions was determined by the Hartwig scale., Methods: This was conducted as a prospective observational study in patients admitted to SRM Medical College, Kattankulathur, Tamil Nadu, India, between November 2016 to August 2018 after obtaining Institutional Ethics Committee clearance of all adverse drug reactions reported at the hospital., Results: Of the 158 ADRs reported during the time period, 101 were cutaneous ADRs, of which the most common presentation was maculopapular rash (n=42; 41.58%). The most common drugs which produced cutaneous adverse reactions were antimicrobials (n=58; 57.42%) followed by NSAIDs (n=35; 34.6%). The causality assessment as per the Naranjo scale yielded 3.96% (4) cases as definite, 81.18% (82) as probable, and 14.85% (15) as possible, whereas the WHO scale yielded 9 (89.10%) certain, 64 (63.36%) probable and 28 (27.72%) possible cases. The severity of the cases determined as per the Hartwig scale yielded 82.17% cases as mild and 17.82% as moderate., Conclusion: It is important to recognise the ADRs at the right time and exert caution in future use. This can minimise harm to the patient both physically and financially and improve the outcome of the treatment., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Background and Objective: Identification of the offending drug is crucial and challenging in cases of severe cutaneous adverse drug reactions (CADR) like Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Poor reproducibility and varying levels of agreement have been observed among different causality assessment tools (CATs) in assessing severe CADRs. This study was conducted to examine the agreement among four different CATs in assessing cases of drug-induced SJS, TEN and SJS/TEN overlap., Methods: All cases of drug-induced SJS, TEN and SJS/TEN overlap, which were reported between January 2012 and January 2020, were identified from the ADR register at an ADR monitoring centre. Causality assessment was done in these reported cases using the following CATs: The World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, Naranjo algorithm, Liverpool algorithm and Algorithm of drug causality for epidermal necrolysis (ALDEN). Weighted kappa (κw) test was used to evaluate the agreement among four CATs., Results: A total of 30 cases of drug-induced SJS, TEN and SJS/TEN overlap were included in our analyses. The most common offending groups of drugs were anticonvulsants (46.7%), antimicrobials (40%) and nonsteroidal anti-inflammatory drugs (13.3%). Of the anticonvulsants, phenytoin (13.3%), carbamazepine (10%), and valproate (10%) were the commonly reported offending drugs. Poor agreement was observed among the four different causality assessment scales., Conclusion: Discrepancies were observed among four different CATs in assessing drug-induced SJS and TEN. A CAT, which is more specific to drug-induced SJS and TEN, simple, user-friendly with limited subjective interpretation, incorporating new immunological and pharmacogenetic markers, is necessary., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)