Current Drug Safety[JOURNAL]
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200 papers
Enhancing the Efficiency of the Individual Case Safety Report (ICSR) Quality and Compliance through Automation.
Link S, Kammler A, Gupta R … +3 more , Hembade M, Kumar R, George V
Curr Drug Saf · 2024 · PMID 37533250 · Publisher ↗
BACKGROUND: Over the past few years, major inspection findings have been identified in the "management of adverse reactions" that may be due to increasing workload in pharmaceutical organizations impacting the correctnes...
BACKGROUND: Over the past few years, major inspection findings have been identified in the "management of adverse reactions" that may be due to increasing workload in pharmaceutical organizations impacting the correctness of information in individual case safety reports (ICSRs). Although retrospective quality check (Retro-QC) and late submission analyses are important steps in ensuring ICSR quality, their manual application poses several challenges that can be overcome through automation. OBJECTIVES: To improve the efficiency of the Retro-QC analysis and late submission analysis using a computer-operated tool called Compliance and Metrics Management (CMM) tool, and to measure the tool's effectiveness in terms of productivity, time, and cost savings by comparing against the manual process. METHODS: Time savings were calculated by measuring the difference in time taken during the manual process versus the automated process. Cost savings were measured in terms of hourly remuneration for the time saved. Productivity was calculated as the difference between the number of cases handled in the manual versus automated process. Thus, the overall efficiency was measured in terms of time and cost savings along with increased productivity. RESULTS: Automation resulted in time savings of 49% and cost savings of 43% for Retro-QC analysis, and the productivity level increased by 67%. For late submission analysis, the CMM tool resulted in time savings of 88% and cost savings of 87%. CONCLUSION: CMM tool enhanced the efficiency of both Retro-QC and late submission analyses by increasing productivity along with time and cost savings. It also reduced the number of errors, thereby enhancing the accuracy of the process and overall compliance.
Dental Disorders Reported to the FDA Adverse Event Reporting System in Association with Buprenorphine: An Analysis by Ingredient Composition and Route of Administration.
Woods RH
Curr Drug Saf · 2024 · PMID 37526182 · Publisher ↗
BACKGROUND: Prior research has suggested buprenorphine-containing medications may be associated with an increased risk of dental disorders. However, published data describing adverse dental reactions in buprenorphine use...
BACKGROUND: Prior research has suggested buprenorphine-containing medications may be associated with an increased risk of dental disorders. However, published data describing adverse dental reactions in buprenorphine users by active ingredient composition and route of administration are limited. OBJECTIVE: The purpose of this study was to evaluate the influence of formulation on spontaneous reporting of dental disorders among patients treated with buprenorphine. METHODS: Adverse event reports submitted to the United States Food and Drug Administration Adverse Event Reporting System (FAERS) between 2015 and 2022 were analyzed. Reporting odds ratios (ROR) and 95% confidence intervals (CI) were calculated to measure disproportionality of dental disorder reporting as classified by 39 Medical Dictionary for Regulatory Activities preferred terms. RESULTS: Compared to pooled reports for all other drugs across FAERS, both buprenorphine monotherapy (ROR 3.09; 95% CI 2.61-3.66) and combination buprenorphine/naloxone (ROR 14.61; 95% CI 13.34-16.01) were associated with positive disproportionality signals. Signals of disproportionate dental disorder reporting were also detected for buprenorphine medicines administered by sublingual (ROR 20.03; 95% CI 18.04-22.24), buccal (ROR 4.46; 95% CI 3.00-6.61) and oral (ROR 7.17; 95% CI 5.03-10.22) routes, but not for other modalities. In considering active ingredient and route together, sublingual buprenorphine monotherapies (ROR 23.55; 95% CI 17.84-31.11) and sublingual buprenorphine/naloxone (ROR 19.47; 95% CI 17.39-21.80) were each associated with disproportionate reporting of dental disorders. CONCLUSION: Subject to the limitations of spontaneous adverse event data, this study identified significantly disproportionate reporting of dental disorders to FAERS among patients treated with buprenorphine- containing medications, including formulations administered by sublingual, buccal and oral routes. These findings are consistent with prior data and suggest that regular oral care and proper dental hygiene be emphasized for patients undergoing therapy with orally dissolving buprenorphine.
Multiple Sclerosis Risk Among Anti-tumor Necrosis Factor Alpha Users: A Methodological Review of Observational Studies Based on Real-world Data.
Li L, Etminan M, Kaplan GG … +3 more , Tremlett H, Xie H, Aviña-Zubieta JA
Curr Drug Saf · 2024 · PMID 37496244 · Publisher ↗
Epidemiologic studies on the risk of multiple sclerosis (MS) or demyelinating events associated with anti-tumor necrosis factor alpha (TNFα) use among patients with rheumatic diseases or inflammatory bowel diseases have...
Epidemiologic studies on the risk of multiple sclerosis (MS) or demyelinating events associated with anti-tumor necrosis factor alpha (TNFα) use among patients with rheumatic diseases or inflammatory bowel diseases have shown conflicting results. Causal directed acyclic graphs (cDAGs) are useful tools for understanding the differing results and identifying the structure of potential contributing biases. Most of the available literature on cDAGs uses language that might be unfamiliar to clinicians. This article demonstrates how cDAGs can be used to determine whether there is a confounder, a mediator or collider-stratification bias and when to adjust for them appropriately. We also use a case study to show how to control for potential biases by drawing a cDAG depicting anti-TNFα use and its potential to contribute to MS onset. Finally, we describe potential biases that might have led to contradictory results in previous studies that examined the effect of anti-TNFα and MS, including confounding, confounding by contraindication, and bias due to measurement error. Clinicians and researchers should be cognizant of confounding, confounding by contraindication, and bias due to measurement error when reviewing future studies on the risk of MS or demyelinating events associated with anti-TNFα use. cDAGs are a useful tool for selecting variables and identifying the structure of different biases that can affect the validity of observational studies.
Inappropriate Use of Proton Pump Inhibitor Among Elderly Patients in British Columbia: What are the Long-term Adverse Events?
Ben-Eltriki M, Chhabra M, Cassels A … +1 more , Wright JM
Curr Drug Saf · 2024 · PMID 37496243 · Full text
BACKGROUND: Proton pump inhibitors (PPIs) are one of the most used classes of drugs. For most indications, PPIs are only recommended up to 8 weeks duration. However, PPI use continues to expand. Regular and prolonged use...
BACKGROUND: Proton pump inhibitors (PPIs) are one of the most used classes of drugs. For most indications, PPIs are only recommended up to 8 weeks duration. However, PPI use continues to expand. Regular and prolonged use of PPIs should be avoided because of the risk of adverse events. OBJECTIVES: The main objective of this study was to (1) investigate the extent of PPI usage in people aged 65 or older in the province of British Columbia (BC), Canada, (2) provide an overview of the harms associated with the long-term use of PPIs. METHODS: We examined utilization trends of the PPIs in BC since the year 2009 using PharmaNet, BC's medication dispensing database where the information is accessible to community pharmacists. We performed a comprehensive literature search for relevant reviews reporting harms associated with long-term use of PPIs. A search was conducted from January 2014 to June 2022. RESULTS: Between 2000 and 2018 BC's population grew by 20%, but the use of PPIs escalated to 257%. Of these older British Columbians, 62% had a cumulative exposure exceeding 2 years and 42% exceeded 5 years. This is alarming because the recommended treatment duration is 4-12 weeks for common indications including reflux esophagitis, and duodenal and gastric ulcers. Only 13.5% were dispensed PPIs for 90 days or less. Patients on long-term PPI therapy should be reassessed. Adverse events of PPI use are common among older adults. We identified over 217 systematic reviews published during the last 8 years of specific harms associated with long-term daily usage of PPIs. These harms include increased risks of death, cardiovascular disease, acute renal injury, chronic kidney disease, dementia, fractures, hypomagnesemia, iron deficiency, vitamin B12 deficiency, enteric infection (including ), pneumonia, and neoplasia (gastric cancer, carcinoids, and colon cancer), and drug interactions. CONCLUSION: This study revealed a high prevalence of PPI use among elderly populations in BC, Canada. The overutilization of PPIs is often a result of failure to re-evaluate the need for continuation of therapy. Published studies identified signals of serious harm from long-term PPI exposure. Healthcare providers with patients can reverse the relentless expansion of long-term PPI exposure by discussing the expected benefits and potential harms.
The Gambia Death Story: 66 Children Died!
Ashique S
Curr Drug Saf · 2024 · PMID 37496139 · Publisher ↗
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Tizanidine Induced Hypotension: Report of a Case and Review of the Literature.
Mahajan R, Kalita J
Curr Drug Saf · 2024 · PMID 37489780 · Publisher ↗
INTRODUCTION: Spasticity is a common sequelae of stroke, and often these patients receive anti-spastic drugs such as baclofen or tizanidine. Stroke patients have multiple co-morbidities such as hypertension, diabetes, an...
INTRODUCTION: Spasticity is a common sequelae of stroke, and often these patients receive anti-spastic drugs such as baclofen or tizanidine. Stroke patients have multiple co-morbidities such as hypertension, diabetes, and seizure. Tizanidine is an α2 and imidazole receptor agonist at a spinal and supraspinal level resulting in reduced central sympathetic outflow and causing hypotension rarely, especially in those receiving beta-blockers or angiotensin-converting enzyme inhibitors. CASE PRESENTATION: We report a 56-year-old hypertensive male presenting with altered sensorium who had recurrent intracerebral hemorrhage with left spastic hemiplegia and focal seizures. He was on amlodipine, atenolol, telmisartan and oxcarbazepine. After 3 doses of tizanidine 2mg, his blood pressure dropped from 140/90 to 80/40 mmHg and pulse from 82 bpm to 44 bpm. His blood counts, serum chemistry, procalcitonin, and Trop I were normal. ECG revealed sinus bradycardia. After 8 hours of withdrawing tizanidine, his blood pressure became 110/70 mmHg, and on the next day, it became 140/82 mmHg. His attendants were taught physiotherapy to minimize spasticity. CONCLUSION: This patient highlights the need for close monitoring of patients receiving tizanidine co-medication with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers. These drugs have a synergistic effect on reducing the renin-angiotensin-aldosterone system, thereby hypotension and bradycardia.
Erythema Multiforme Reactions Following Pfizer/BioNTech (Tozinameran) Vaccination: Two Case-Reports with Positive Rechallenge and Review of the Literature.
Charfi O, Lakhoua G, Berrim K … +6 more , Kastalli S, Badri T, Aouinti I, Daghfous R, Zaiem A, Aidli SE
Curr Drug Saf · 2024 · PMID 37489779 · Publisher ↗
AIM: Pfizer/BioNTech (BNT162b2) is a COVID-19 vaccine with a reassuring safety profile. The main adverse reactions are mild local reactions. Cutaneous reactions are generally minor. The most common cutaneous reaction rep...
AIM: Pfizer/BioNTech (BNT162b2) is a COVID-19 vaccine with a reassuring safety profile. The main adverse reactions are mild local reactions. Cutaneous reactions are generally minor. The most common cutaneous reaction reported was a local injection-site reaction. CASE STUDY: Here we present 2 cases of erythema multiform (EM) following BNT162b2 vaccination with positive rechallenge. The 1 case was about a 51-year-old woman who developed 5 days after the 1st dose of the mRNA Pfizer/BioNTech (BNT162b2) a macular, erythematous, roundshaped lesions on the hands, knees and soles. She experienced a positive rechallenge one month later. In the 2 case, a 55-year-old man presented 6 days following the 2 shot of the mRNA Pfizer/ BioNTech (BNT162b2), targetoid eruption on the upper and lower members. The patient reported that he had the same skin lesions in ankles and soles few days following the 1 shot of the same vaccine. CONCLUSION: Few cases of EM following COVID-19 vaccination were reported in the literature and positive rechallenge in only one case. Rechallenge was not performed in most cases. Our two cases are particular because of the positive rechallenge in both patients. This is the gold standard to confirm that the vaccine was the culprit agent in inducing EM.
The Effect of Renal Replacement Therapy in a Patient with Mercaptopurine Toxicity: Time to Revise Guidelines.
Quaedvlieg HJL, Polderman FN, Borkent M … +5 more , Jonge HJM, Annema PA, Derijks LJJ, Sikma MA, Bethlehem C
Curr Drug Saf · 2024 · PMID 37455454 · Publisher ↗
INTRODUCTION: Mercaptopurine, a thiopurine, is used in various disorders of immune regulation, such as autoimmune hepatitis. Thiopurine metabolism is complex with risk for overdosing, especially when metabolism is impair...
INTRODUCTION: Mercaptopurine, a thiopurine, is used in various disorders of immune regulation, such as autoimmune hepatitis. Thiopurine metabolism is complex with risk for overdosing, especially when metabolism is impaired by liver dysfunction. Hepatotoxicity may be due to mercaptopurine overdose and is often reversible after prompt cessation of the drug. CASE PRESENTATION: Treatment of thiopurine toxicity is mainly supportive and literature on enhanced elimination by renal replacement therapy is ambiguous. CONCLUSION: In this case of thiopurine toxicity, a patient with autoimmune hepatitis presents with abdominal pain, nausea, vomiting, and diarrhea. We show in this case report that renal replacement therapy had no effect on total body clearance of mercaptopurine.
Development of Dermatomyositis after Pfizer BioNTeh COVID-19 Vaccine: A Case Report.
Aouintia I, Daly W, Lakhoua G … +6 more , Kaabi W, Charfi O, Debbeche S, Kastalli S, Zaiem A, El Aidli S
Curr Drug Saf · 2024 · PMID 37317919 · Publisher ↗
INTRODUCTION: The Coronavirus Disease 2019 (COVID-19) pandemic led to the fast development of vaccines, which is considered a medical advance in healthcare. With the extensive vaccination campaign performed worldwide, ma...
INTRODUCTION: The Coronavirus Disease 2019 (COVID-19) pandemic led to the fast development of vaccines, which is considered a medical advance in healthcare. With the extensive vaccination campaign performed worldwide, many adverse events following immunization (AEFI) were reported. Most of them were flu-like symptoms, mild and self-limiting. However, serious adverse events, such as dermatomyositis (DM), an idiopathic autoimmune connective tissue disease, have also been reported. CASE PRESENTATION: In this report, we describe a case of skin erythema, edema, and diffuse myalgia attributed at first to Pfizer BioNTeh, COVID-19 vaccination, given the temporal relationship and the absence of significant medical history. The causality assessment score was I1B2. However, after completing the etiological assessment, an invasive breast carcinoma was identified, and we retained the diagnosis of paraneoplastic DM. CONCLUSION: This study underlines the importance of completing the etiological assessment before attributing any adverse reaction to vaccination to maintain optimal patient care.
Calcium Folate for Reducing the Side Effects of Low-dose Methotrexate in Rheumatoid Arthritis: A Case Report.
Liu R, Yan Q, Hu Y … +1 more , Liu X
Curr Drug Saf · 2024 · PMID 37309770 · Publisher ↗
INTRODUCTION: We reported a patient with rheumatoid arthritis who received chronic methotrexate (MTX) therapy and experienced several adverse reactions like hemocytopenia and renal impairment. Under the monitoring of the...
INTRODUCTION: We reported a patient with rheumatoid arthritis who received chronic methotrexate (MTX) therapy and experienced several adverse reactions like hemocytopenia and renal impairment. Under the monitoring of the therapeutic drug concentration, calcium folate and other measures were used to accelerate methotrexate excretion and eliminate adverse reactions. CASE PRESENTATION: A 66-year-old man with rheumatoid arthritis received MTX and developed adverse effects of bone marrow suppression, like pancytopenia. He had a black stool, and he tested positive for occult blood, which was considered gastrointestinal bleeding. The blood MTX concentration reached 4.07 μmol/L, and leucovorin was administered to rescue the patient's life. Besides, hydration and alkaline urine were applied to quickly clear methotrexate inside the body. CONCLUSION: Low-dose MTX has fewer adverse reactions but may cause bone marrow suppression- related side effects. Blood concentration monitoring can be used to guide the rescue of MTX poisoning.
Polymeric Micelles as Drug Delivery System: Recent Advances, Approaches, Applications and Patents.
Jain A, Bhardwaj K, Bansal M
Curr Drug Saf · 2024 · PMID 37282644 · Publisher ↗
Administering therapeutics through the oral route is a pervasive and widely approved medication administration approach. However, it has been found that many drugs show low systemic absorption when delivered through this...
Administering therapeutics through the oral route is a pervasive and widely approved medication administration approach. However, it has been found that many drugs show low systemic absorption when delivered through this route. Such limitations of oral drug delivery can be overcome by polymeric micelles acting as vehicles. As a result, they improve drug absorption by protecting loaded drug substances from the gastrointestinal system's hostile conditions, allowing controlled drug release at a specific site, extending the time spent in the gut through mucoadhesion, and inhibiting the efflux pump from reducing therapeutic agent accumulation. To promote good oral absorption of a weakly water-soluble medicinal drug, the loaded medicine should be protected from the hostile atmosphere of the GI tract. Polymeric micelles can be stacked with a broad assortment of ineffectively dissolvable medications, improving bioavailability. This review discusses the major mechanism, various types, advantages, and limitations for developing the polymeric micelle system and certain micellar drug delivery system applications. The primary goal of this review is to illustrate how polymeric micelles can be used to deliver poorly water-soluble medications.
A Routine over the Counter Phenylephrine Causing Rarer Drug Eruption as Adverse Drug Reaction - A Case Report.
Yella SST, Krishna Sasanka KSBS, Singh H … +1 more , Meena B
Curr Drug Saf · 2024 · PMID 37264618 · Publisher ↗
BACKGROUND: Phenylephrine is a sympathomimetic, which means it acts analogous to adrenaline. Phenylephrine can be taken orally to treat nasal congestion symptoms. It is also frequently mixed with other medicines in produ...
BACKGROUND: Phenylephrine is a sympathomimetic, which means it acts analogous to adrenaline. Phenylephrine can be taken orally to treat nasal congestion symptoms. It is also frequently mixed with other medicines in products meant to relieve cough and cold symptoms. Given the widespread usage of phenylephrine, related drug eruptions appear to be uncommon. CASE PRESENTATION: Here we discuss a case of a 19-year-old female patient who reported to our hospital with blebs on the skin throughout her legs and torso. The drug eruption or adverse drug response was linked with itching, had a slow beginning, and progressed. Her medical history indicated that she had been taking phenylephrine 10 mg orally twice a day. On the sixth day, she experienced an adverse medication response caused by the medicine phenylephrine. Phenylephrine was stopped immediately and the other medications, such as levocetirizine, montelukast, and nasal spray, were continued. The patient was told not to use phenylephrine, either alone or in combination with FDCs. There are no other complaints. As a result, the patient was diagnosed with phenylephrine- induced eruption. CONCLUSION: We present this case to highlight the importance of inspiring a pharmacovigilance mindset among all clinicians providing care as a routine alert drug, phenylephrine-induced drug eruption.
Osimertinib-induced Keratitis and Secondary Toxic Epidermal Necrotic Drug Eruption- A Case Report and Literature Review.
Xu Y, Li Y, Luo J … +1 more , Tang R
Curr Drug Saf · 2024 · PMID 37254553 · Full text
BACKGROUND: Osimertinib is a third-generation Tyrosine Kinase inhibitor, mainly used in non-small cell lung cancer with EGFR mutation. Its efficacy and safety have been confirmed by clinical practice. Toxic epidermolysis...
BACKGROUND: Osimertinib is a third-generation Tyrosine Kinase inhibitor, mainly used in non-small cell lung cancer with EGFR mutation. Its efficacy and safety have been confirmed by clinical practice. Toxic epidermolysis necrotizing disease (TEN) is a severe drug eruption that is rare in clinics and has a high mortality rate. Toxic epidermal necrotic drug rash caused by Osimeritinib is even rarer. OBJECTIVE: To investigate the rare side effects of Osimertinib through a case of toxic Epidermal necrosis. CASE PRESENTATION: A 63-year-old female patient was diagnosed with lung adenocarcinoma with brain metastases, and genetic testing revealed an EGFR21 exon mutation. The disease progressed 24 days after the administration of gefitinib, then the patient switched to Osimertinib (80 mg QD) and, resulting in keratitis and secondary systemic toxic epidermolysis necrotizing disease (TEN). Finally, the patient died. CONCLUSION: Although the clinical use of osimertinib is becoming widespread, the side effects may not be fully understood. Clinicians should pay more attention to the occurrence of the side reaction and deal with it in time.
Treatment with Rituximab in Rheumatoid Pneumoconiosis: A Case Report.
Yasmine M, Kaouther M, Dhia K … +4 more , Hanene F, Wafa T, Dorra BN, Wafa H
Curr Drug Saf · 2023 · PMID 37254279 · Publisher ↗
BACKGROUND: Caplan's syndrome, also known as rheumatoid pneumoconiosis (RP), is a rare disease associating pneumoconiosis with rheumatoid arthritis (RA). This is one of the rare cases evaluating the effect of Rituximab,...
BACKGROUND: Caplan's syndrome, also known as rheumatoid pneumoconiosis (RP), is a rare disease associating pneumoconiosis with rheumatoid arthritis (RA). This is one of the rare cases evaluating the effect of Rituximab, which was used initially for the treatment of RA, on pneumoconiosis Case Presentation: In this case report, we described a 21-year long-standing history of pneumoconiosis and its association with RA. A 67-year-old man diagnosed with pneumoconiosis presented with morning stiffness and symmetrical polyarthritis. Laboratory investigations showed high titers of rheumatoid factor (RF) and anti-citrullinated protein antibodies. The diagnosis of RA was established and the patient was put on leflunomide. Then, he was treated with Rituximab, as he did not respond to leflunomide. The patient showed marked improvement as pain and swelling decreased. More importantly, Caplan's nodules stabilized on chest-computed tomography. CONCLUSION: The use of rituximab in pneumoconiosis does not alter the evolution of the pulmonary nodules. More trials are needed to establish a treatment consensus for RP.
Therapeutic Drug Monitoring of Tacrolimus in Tunisian Renal Transplant Patients during the Tuberculosis Infection: A Retrospective, Observational, Single-centre Analysis.
Ammar H, Sassi MB, Charfi R … +4 more , Jebar HE, Daghfous R, Gaies E, Trabelsi S
Curr Drug Saf · 2023 · PMID 37254278 · Publisher ↗
UNLABELLED: Tuberculosis is a challenge in organ transplantation due to the interaction between Anti- Tuberculosis Treatment (ATT) and immunosuppressive drugs, such as Tacrolimus (TAC). This study aimed to assess this in...
UNLABELLED: Tuberculosis is a challenge in organ transplantation due to the interaction between Anti- Tuberculosis Treatment (ATT) and immunosuppressive drugs, such as Tacrolimus (TAC). This study aimed to assess this interaction and discuss the guidelines used in this specific case. METHODS: A retrospective, observational, single-center analysis was performed at the Department of Clinical Pharmacology (National Centre of Pharmacovigilance, Tunisia). We analyzed the database of patients who received TAC from 2009 until 2018. We included samples provided from renal transplant patients infected by Mycobacterium tuberculosis after transplantation. Trough blood levels (C0) were determined using an immunoassay analyzer. The Therapeutic Range (TR) of TAC was considered between 5 and 10 ng/mL. Pharmacokinetic parameters were compared between the period of co-administration of TAC/ATT (period A) and the period during which patients received only TAC (period B). RESULTS: Seven renal transplant patients treated by TAC were included. 41 samples were analyzed (16; period A, 25; period B). Only 6 % of C0 values were found within TR during period A, while this rate was 44% during period B. During period A, 88% of TAC C0 was under the lower limit of TR, indicating a high risk of transplant rejection. The mean C0 and C0/D were significantly lower during period A (3.11±1.53 ng/mL vs 7.11 ± 3.37 ng/mL; p = 0.001 and 33.06 ± 24.89 vs 83.14 ± 44.46; p = 0.0006, respectively), without difference in doses between periods. CONCLUSION: Considering the results of this study, clinicians are suggested to monitor TAC closely in this particular circumstance.
Adverse Effects Post COVID-19 Vaccination and its Association with Age, Gender and Comorbid Disease in Basrah City Southern of Iraq.
Abdul-Nabi ZN, Mohamed-Jawad NK, Fareed NY … +2 more , Neamah NF, Shari FH
Curr Drug Saf · 2024 · PMID 37231751 · Publisher ↗
BACKGROUND: Vaccination against COVID-19 virus is the most valuable tool available for protection during the pandemic of coronavirus. The clinical manifestation post-vaccination is a barrier to vaccination for many peopl...
BACKGROUND: Vaccination against COVID-19 virus is the most valuable tool available for protection during the pandemic of coronavirus. The clinical manifestation post-vaccination is a barrier to vaccination for many people in Iraq and worldwide. OBJECTIVES: The objective of this study is identifying various clinical manifestations occurring after receiving vaccines among individuals in Basrah Governorate. Moreover, we examine its association with respondents' demographics and the type of vaccine they received. METHODS: A cross-section study was conducted in Basrah, southern Iraq. Research data were collected through an online questionnaire. The data were analyzed using both descriptive and analytic statistical tools using the SPSS program. RESULTS: Most of the participants (86.68%) received the vaccine. The side effects were reported in 71.61% of vaccinated individuals. Fever and muscle pain were the two most experienced clinical manifestations, while lymph node enlargement and disturbances in taste and/or smell sensations were reported infrequently. Adverse effects were mostly reported with the Pfizer BioNTech vaccine receiver. Females and those in the younger age group also reported a significantly higher incidence of side effects. CONCLUSION: Most adverse effects related to the COVID-19 vaccine were minor and could be tolerated without the need for hospital admission.
Penicillamine-induced Stevens Johnson Syndrome-toxic Epidermal Necrolysis (SJS-TEN) Overlap in an HIV-infected Patient with Wilson's Disease and Hepatitis B.
Chhabra N, Reddy PSM, Bhatnagar A … +1 more , Ganguly S
Curr Drug Saf · 2024 · PMID 37231731 · Publisher ↗
INTRODUCTION: Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN) are severe adverse drug reactions characterized by widespread blistering and mucositis. Wilson's disease is a rare, autosomal recessive di...
INTRODUCTION: Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN) are severe adverse drug reactions characterized by widespread blistering and mucositis. Wilson's disease is a rare, autosomal recessive disorder that results in excessive copper accumulation in the body, where penicillamine is an effective treatment option for copper chelation. Penicillamineinduced SJS-TEN is a rare but potentially fatal adverse effect. There is increased susceptibility to SJS/TEN in HIV infection due to immunosuppression and chronic liver disease due to impaired hepatic function. OBJECTIVE: To diagnose and manage the occurrence of the rare severe adverse cutaneous drug reactions in the backdrop of immunosuppression and chronic liver disease. CASE REPORT: We are reporting penicillamine-induced SJS-TEN overlap in a 30-year-old male with Wilson's disease, HIV and Hepatitis B who was treated with intravenous immunoglobulins. The patient later developed neurotrophic ulcer in the right cornea as a delayed sequela. CONCLUSION: Our case report emphasizes that there is an increased predisposition to SJS/TEN in immunocompromised and chronic liver disease patients. Physicians should be well aware of the potential danger of SJS/TEN in this subset of patients, even while prescribing a relatively safer drug.
Remimazolam and Remifentanil Use Induced Severe Respiratory Depression and Laryngeal Spasm During Intravenous Sedation and Analgesia: A Case Report.
Xin Z, Wang N, Wang H
Curr Drug Saf · 2024 · PMID 37198992 · Full text
INTRODUCTION: Intravenous sedation and analgesia are widely used in minor surgeries. Remifentanil and remimazolam are advantageous in this setting because of their rapid onset of action, and short duration of action lead...
INTRODUCTION: Intravenous sedation and analgesia are widely used in minor surgeries. Remifentanil and remimazolam are advantageous in this setting because of their rapid onset of action, and short duration of action leading to a rapid recovery. However, the two drugs combined need to be titrated to avoid airway-related adverse events. CASE PRESENTATION: This article reports a case of severe respiratory depression and severe laryngeal spasm induced by remifentanil and remimazolam when they were used for analgesia and sedation in a patient undergoing oral biopsy. CONCLUSION: We aim to improve awareness about the safety of these drugs among anesthesiologists and increase their ability to manage the risk associated with their use.
Methotrexate-induced Severe Pancytopenia in a Patient with Rheumatoid Arthritis: A Case Report and Review of Literature.
Hosseini E, Shahbazi F
Curr Drug Saf · 2024 · PMID 37194235 · Publisher ↗
Toxicity associated with low doses of methotrexate (MTX) is low, but it may be fatal. Bone marrow suppression and mucositis are among the common side effects of low dose MTX toxicity. Different risk factors have been rep...
Toxicity associated with low doses of methotrexate (MTX) is low, but it may be fatal. Bone marrow suppression and mucositis are among the common side effects of low dose MTX toxicity. Different risk factors have been reported for toxicities associated with low doses of MTX, including accidental use of higher doses, renal dysfunction, hypoalbuminemia, and polypharmacy. In this paper, we present a female patient who had mistakenly used 7.5 mg of MTX daily instead of the same dose of MTX on Thursday and Friday. She was presented with mucositis and diarrhea to the emergency department. Moreover, we searched the databases Scopus and PubMed for available studies and case reports on toxicities associated with MTX dosing errors. The most frequently observed toxicities included gastrointestinal lesions, nausea, vomiting, skin lesions, and bone marrow suppression. Leucovorin, hydration, and urine alkalinization were among the most frequently used treatments. Finally, we summarize the data on the toxicities of low doses of MTX in different diseases.
Concise Review on Scientific Approaches to Burns and Scars.
Malhotra H, Sharma P, Kamal MA … +2 more , Kaushik P, Rani N
Curr Drug Saf · 2024 · PMID 37165593 · Publisher ↗
Burns are large open surgical lesions bathed in virulent pus that result in rupturing of the cutaneous membrane, which has serious consequences such as an extensive loss of proteins, and body fluids, increased chances of...
Burns are large open surgical lesions bathed in virulent pus that result in rupturing of the cutaneous membrane, which has serious consequences such as an extensive loss of proteins, and body fluids, increased chances of infections, and sometimes death. These can be classified based on their penetration levels, i.e., first-degree burns penetrating the epidermis, second-degree burns including both epidermis and dermis, third-degree burns to both layers including the hair follicular cells, sweat glands and various core tissues, fourth-degree burns to adipose tissue, fifth stage burns to muscles, and sixth stage burns to bones. Wound healing/wound repair is a very perplexing process in which the tissues of the affected/burnt area repairs themselves to attain their original form and functionality but develop a scar at the wound site. This article mainly focuses on the algorithms to differentiate various degrees of burns, general first aid approaches to burns and scars, the rationale of treatment of burns, basic mechanisms highlighting the healing processes in humans in terms of free from scar formation as well as with scar formation at their elementary levels including cellular as well as biochemical levels, utility, and progression of pre-clinical data to humans and finally approaches for the improvement of scar formation in man.
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