Current Drug Safety - Online First
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Tubulointerstitial Nephritis in ANCA-Associated Vasculitis as a Rare Adverse Effect of Adalimumab: A Case Report
Authors: Myriam Ayari, Maha Mtir, Ikram Mami, Lamia Rais, Sarah Ben Azouz, Hedi Douggui and Taieb JomniAvailable online: 26 March 2025More LessBackgroundPatients with inflammatory disease treated with biological agents are at an increased risk of developing various adverse effects. However, little is known about the risk of nephrotoxicity, such as induced tubulointerstitial nephritis and immune-mediated inflammatory diseases involving the interstitium and renal tubule.
Case PresentationWe herein describe a case of biopsy-proven tubulointerstitial nephritis, induced by PR3-ANCA-associated vasculitis following adalimumab therapy in a patient with Crohn's disease and ankylosing spondylitis. We review the current evidence on adalimumabinduced nephrotoxicity and the potential underlying mechanisms.
ConclusionMonitoring of renal function is strongly recommended in all patients treated with adalimumab. Early diagnosis of drug-induced tubulointerstitial nephritis due to vasculitis and immediate withdrawal of the offending drug are key to renal recovery and prevention from irreversible serious organ damage.
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Linezolid Related Adverse Effects in Different Populations: A Practical Review
Available online: 25 March 2025More LessLinezolid, an oxazolidinone antibiotic, is used to treat gram-positive infections. Linezolid, an oxazolidinone antibiotic, is used to treat gram-positive infections. However, it may also lead to serious adverse effects, including bone marrow suppression, optic neuropathy it may also lead to serious adverse effects, including bone marrow suppression, optic neuropathy, peripheral neuropathy, hyponatremia, and lactic acidosis. This review evaluates the existing evidence concerning the adverse effects of linezolid in patients undergoing treatment with this medication, both in the short and long term. The objective of this review is to summarize the most significant adverse effects associated with linezolid. A search of PubMed was conducted for articles related to linezolid and its potential adverse effects, which include thrombocytopenia, anemia, neutropenia, lactic acidosis, optic neuropathy, and peripheral neuropathy. Thrombocytopenia frequently develops within the first two weeks of therapy, whereas anemia is more likely to manifest during prolonged treatment courses. Risk factors for linezolid-induced thrombocytopenia include elevated trough concentrations (>8 mg/L), renal impairment, low body weight, and severe liver dysfunction. Patients with multidrug-resistant tuberculosis and bone infections are at an increased risk for anemia, peripheral neuropathy, and optic neuropathy. Additionally, lactic acidosis and hyponatremia can occur at any stage during treatment.
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Clinical Manifestations of Neuropathic Pain and the Deleterious Effects of Chemotherapeutic Agents
Authors: Moumita Ghosh, Manodeep Chakraborty, Ananya Bhattacharjee and Nihar Ranjan BhuyanAvailable online: 24 March 2025More LessNeuropathic pain is a type of pain resulting from damage or dysfunction of the nervous system. Chemotherapy-induced peripheral neurotoxicity (CIPN) is a serious complication of cancer treatment, often occurring in a dose-dependent manner. CIPN is a sensory neuropathic syndrome characterized by motor and autonomic alterations of varying intensity and duration. The lack of effective treatment options for CIPN makes it a significant clinical challenge. A variety of chemotherapeutic agents can contribute to the development of CIPN, including vinca alkaloids, platinum-based antineoplastic agents, epothilones (ixabepilone), proteasome inhibitors (bortezomib), taxanes, and immunomodulatory drugs (thalidomide), along with the genetic factors. Single nucleotide polymorphisms (SNPs) in genes, such as CEP72 and EPHA, have been linked to increased susceptibility to CIPN. The treatment options for CIPN are limited and often require careful consideration due to potential side effects and patient comorbidities. Pharmacological interventions, such as anticonvulsants, gabapentin, and pregabalin, are commonly used to manage neuropathic pain. Tricyclic antidepressants like amitriptyline and nortriptyline can be effective, but their use may be limited due to side effects. In severe cases, opioids may be considered, but they should be used cautiously due to the risk of addiction and other adverse effects. The lidocaine or capsaicin creams and patches can provide localized pain relief. The non-pharmacological interventions like physical therapy can help improve strength, balance, and mobility. Transcutaneous electrical nerve stimulation and spinal cord stimulation are invasive procedures that may be considered for severe, intractable pain. Complementary therapies and cognitive-behavioural therapy can help patients cope with pain and improve their quality of life.
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Self-Micro-Emulsifying Drug Delivery Systems: In-Depth Review on Enhancing Solubility and Therapeutic Efficacy of BCS Class II Drugs
Authors: Lipanjali Badhei, Prafulla Nandi, Debashis Mishra and Himansu Bhusan SamalAvailable online: 13 March 2025More LessThe development of self-micro-emulsifying drug delivery system (SMEDDS) has revolutionized pharmaceutical formulation by providing an advanced method of increasing medication bioavailability and therapeutic effectiveness. The systems encapsulate hydrophobic drugs in nanoscale droplets and enable them to be soluble and stable in water via the spontaneous formation of oil in water emulsions when gently agitated. Using SMEDDS, pharmaceuticals can be extended to offer enhanced therapeutic potential, and new medicines can be developed that were previously impossible to develop due to their bioavailability limitations. They are versatile and user-friendly, helping to reduce pill burden and improve comfort, which can support better compliance and outcomes. Challenges such as formulation stability and regulatory compliance have been identified in various literature as hurdles for adopting SMEDDS in clinical applications. To address these gaps, this work covers multiple components used in SMEDDS, their classification, formulation methods, characterization, and their advantages and disadvantages. In order to expedite the application of Self-Emulsifying Drug Delivery Systems (SEDDS) in pharmaceutical research, it offers comprehensive statistics on all the necessary aspects of self-micro-emulsifying formulations. Several emulsion-based technologies suitable for edible delivery methods in the drug, cosmetics, and other industries are described. These consist of filled hydrogel particles, solid lipid particles, multiple emulsions, multilayer emulsions, and traditional emulsions.
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Certolizumab-Induced Urticarial Vasculitis: A Case Report
Available online: 13 March 2025More LessIntroductionCertolizumab (CZ) is a tumour necrosis factor-α (TNF-α) blocking agent with excellent efficiency in rheumatoid arthritis (RA). Urticarial vasculitis (UV) induced by CZ is a rare side effect. Herein, we describe a patient with UV probably induced by CZ therapy.
Case PresentationA 33-year-old female with RA was treated with methotrexate and corticosteroids, which resulted in no improvement. The patient was switched to CZP, and one week later, she developped urticaria (erythematous and edematous plaques). The diagnosis of urticarial vasculitis related to CZ was suspected. The results of microbiological and autoimmunity tests ruled out other causes of vasculitis. The diagnosis of CZ-induced-UV was retained (Naranjo’s score: 5). CZ was withdrawn, which led to rapid resolution of skin lesions.
ConclusionWith the increasing use of CZ, physicians should be aware of the possibility of UV associated with CZ.
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Revealing the Future of Pharmacovigilance in Precision Pharmaceutical Monitoring
Authors: Vishnu Mittal and Anjali SharmaAvailable online: 11 March 2025More LessThe growing popularity of personalized medicine presents new hazards and difficulties for pharmacovigilance. This implies that it needs to modify its current approach. This research examines how drug safety monitoring for certain medications evolves over time. We briefly discuss the connection between meticulous pharmacovigilance procedures and adaptable treatment approaches. We describe how pharmacogenetics may be used to make drugs safer and how genetic testing may be used to forecast a drug's potential side effects. With an emphasis on post-marketing monitoring in phase IV, we address shortcomings of research on pre-marketing and the need for a comprehensive strategy for medication safety. The significance of pharmacogenetics in reducing risk before exposure and the need to reconsider pharmacoepidemiological techniques for monitoring outcomes after exposure are discussed in the study. We emphasize the significance of including genetic patient-specific profiles in publications related to tailored therapy and the use of state-of-the-art computer techniques for data processing. We also discuss privacy, ethical, and data security issues that arise with precision medicine, emphasizing the consequences for patient consent and data management.
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Managing Opioid Tolerance: Balancing Pain Relief and Tackling Addiction
Authors: Astha Mehta, Anunav Ashish and Shubham ThakurAvailable online: 10 March 2025More LessThis editorial discusses opioid tolerance, a growing challenge in managing pain in chronic patients. With time, overuse of opioids causes less sensitivity and responsiveness of opioid receptors and leads to higher doses of opioids for the same level of pain management. Due to this, it increases the risk of side effects, such as opioid addiction, respiratory issues, and overdose. The editorial highlights the relationship between opioid use disorder (OUD) and opioid tolerance and discusses the difficulty faced by patients and doctors during opioid tolerance. To address these challenges, a multimodal pain management approach, including physical therapies, cognitive-behavioural therapy, and opioid rotation, is proposed to enhance pain relief while reducing dependency. Policy changes and further research into alternative pain management methods and mechanisms of opioid tolerance in patients are needed to improve and limit the opioid crisis effectively.
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Efficacy and Safety Profile of Suvorexant for the Treatment of Insomnia
Authors: Ariba Sabat, Aakriti Garg and Mohd Ashif KhanAvailable online: 03 March 2025More LessInsomnia is becoming a concern in general practice as it affects around 30% of adults. It is a sleep disorder characterized by trouble getting asleep, staying asleep, waking up early, and difficulty falling back to sleep. The most commonly used hypnotics, such as benzodiazepines, Z drugs, etc, are associated with various issues, including psychomotor and cognitive impairment. Dual orexin receptor antagonists are an emerging class of hypnotics used to treat insomnia. Suvorexant is a first-in-class dual orexin receptor antagonist approved by the US FDA in 2014 for the treatment of insomnia. Suvorexant is administered orally, absorbed well, metabolized by cytochrome P450 enzyme, and excreted through feces. Some common adverse effects of suvorexant are headache, somnolence, dizziness, diarrhea, cough, abnormal dreams, and upper respiratory tract infection. The current paper aimed to review the pharmacokinetics and pharmacodynamic properties of suvorexant.
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A Biochemical Investigation of the Prevalence of Hypercalcemia and Thiazide-Related Hypercalcemia in Patients
Available online: 25 February 2025More LessIntroduction and ObjectiveHypercalcemia allied with thiazide diuretics is a widely acknowledged clinical presentation. Hence, the purpose of this investigation was to ascertain the prevalence of hypercalcemia and hypercalcemia linked to thiazides and to evaluate serum phosphorous, 25-hydroxyvitamin D, and parathyroid hormone (PTH).
MethodsThis prospective, cross-sectional research study involved all patients, including outpatients, and was conducted over a 12-month period. Between December 2017 and December 2018, an aggregate of 373 patients were enrolled. All patients with hypercalcemia (albumin-corrected serum calcium > 10.8 mg/dL) had their medical information put on a proforma, together with the results of any tests (such as parathyroid hormone (PTH), 25-hydroxyvitamin D, and serum phosphorus).
ResultsOut of 373 subjects, 7 (2%) were hypercalcemic. The mean corrected calcium levels in the normo-calcemic group were 9.46 ± 0.60 mg/dL (95% CI, 9.4 – 9.5), and that in the hypercalcemic group were 11.68 ± 0.82 mg/dL (95% CI, 10.9 – 12.4). Of the seven cases of hypercalcemia, 2 patients (28.6%) had thiazide-associated hypercalcemia (TAH) along with primary hyperparathyroidism (PHPT). Of the remaining 5 hypercalcemia patients, two more had PHPT, and one (14.3%) had hypervitaminosis D, whereas no cause was mentioned in the remaining 2 patients. Among the 4 PHPT patients, corrected calcium was slightly higher in those with TAH vs those without TAH, though the difference was statistically insignificant (11.32 ± 0.43 vs 11.14 ± 0.39 mg/dL; P > 0.7).
ConclusionTAH is the second primary cause of asymptomatic hypercalcemia after PHPT. Thus, close coordination between the clinicians, pharmacology, pharmacovigilance, and the biochemistry department may help in identifying these cases.
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Advancements in Colon Cancer Therapy: A Review on Docetaxel and the Role of Nanotechnology in Enhancing Efficacy
Authors: Komal, Dinesh Kumar, Sharib Raza Khan, Prabhjot Kaur, Kankan Majumdar, Nabaparna Chakraborty and Amandeep SinghAvailable online: 14 February 2025More LessDocetaxel exhibits high protein binding and P450-mediated metabolism, which influences its pharmacokinetics. As a taxane-family chemotherapeutic agent, it stabilizes microtubules and disrupts cell division. Combining docetaxel with agents like 5-fluorouracil and oxaliplatin enhances treatment outcomes for colon cancer. Emerging drug delivery systems, including nanoparticles and micelles, aim to improve efficacy while reducing toxicity. However, its safety during pregnancy remains uncertain, and ongoing clinical trials continue to evaluate its therapeutic potential.
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Transdermal Drug Delivery Systems: Integrating Modern Technology for Enhanced Therapeutics
Available online: 11 February 2025More LessIntroduction/ObjectiveIn recent years, transdermal drug delivery systems (TDDS) have gained popularity as a non-invasive, patient-friendly medication delivery method. This review article examines the latest transdermal medication delivery developments and breakthroughs. The review begins with a brief summary of transdermal medication administration, stressing the skin's barrier role and drug permeation methods. Novel materials and methods improve drug solubility, stability, and skin permeability in formulation technologies.
MethodsA literature review of the most recent innovations in TDDS, such as nano-based delivery systems, microneedles, and smart patches, was conducted. Major challenges of drug solubility, stability, and skin permeability were carefully discussed, along with the transdermal patch designs of new therapeutic applications in pain management, cardiovascular diseases, and hormone therapy.
ResultsTransdermal medication delivery difficulties may be overcome via nano-based drug delivery systems, microneedle arrays, and smart patches. Furthermore, the paper discusses current advances in transdermal patch design for therapeutic applications, highlighting effective instances in pain management, cardiovascular illness, and hormone therapy.
ConclusionThe article examines transdermal medication delivery regulations, safety, and patient compliance in addition to technological advances. The complete study in this review seeks to help academics, doctors, and pharmaceutical professionals understand transdermal drug delivery and its future. Understanding recent advances in this field can help stakeholders design more effective and patient-friendly transdermal drug delivery systems, enhancing treatment outcomes and patient well-being.
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Comprehensive Review of Gestational Diabetes: Pathophysiology, Pharmacological Management and the Role of Pharmaceutical Care
Authors: Abdulkadir Abdu and Hossamaldeen BakreyAvailable online: 31 January 2025More LessThis review addresses the significant part pharmacological treatment plays in treating gestational diabetes mellitus (GDM), therefore enhancing the results for mother and child. Talking about the frequency and relevance of GDM would help to underline the need for good management. The pathophysiology presents a thorough examination of the fundamental processes, clarifying how hormonal changes seen during pregnancy lead to insulin resistance and raised blood sugar levels. The pharmacological treatment approaches for GDM, including insulin treatment and oral hypoglycemic medications, are investigated in this paper. Taking into consideration the hazards of generating birth deformities and safety data, the paper also evaluates the safety of the drugs in diabetes pregnancy in order to offer best treatment results. Moreover, the function of pharmacists in GDM highlights their significance in patient education, ensuring adherence to medication and overseeing therapy in collaboration with multidisciplinary teams. Furthermore, the impact of pharmaceutical care on maternal and neonatal outcomes demonstrates how pharmaceutical interventions can effectively reduce complications like preeclampsia and neonatal hypoglycemia, highlighting the importance of personalized medication management. Finally, the challenges and future directions of GDM address the difficulties in pharmaceutical care, including patient compliance, healthcare access and emerging treatment methods, calling for more research and policy initiatives to improve pharmaceutical care frameworks and enhance health outcomes for both mothers and infants. This comprehensive review highlights the need for integrated pharmaceutical care in managing GDM and its potential to improve health outcomes for both mothers and infants.
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Rhabdomyolysis Following Trimethoprim-Sulfamethoxazole Therapy: A Case Report and Review of the Literature
Available online: 29 January 2025More LessBackgroundTrimethoprim-Sulfamethoxazole (TMP-SMX) is a commonly used antibiotic for the treatment of several infections, such as urinary tract infections, respiratory infections, and in certain cases, septic arthritis. Rhabdomyolysis (RM) is very rare and less than 20 cases have been reported, so far, in the literature, in particular in immunocompromised patients. Here, we report a case of TMP-SMX-induced RM in an immunocompetent patient, adding to the limited data on this association.
Case PresentationA 53-year-old male patient with no prior medical history presented with septic arthritis and was initiated on TMP-SMX therapy. Within days, he developed muscle pain and weakness with laboratory tests revealing markedly elevated Creatine Kinase (CK) levels, consistent with rhabdomyolysis. Following the discontinuation of TMP-SMX, the patient’s CK levels gradually decreased, and his symptoms resolved without further intervention.
ConclusionTo our knowledge, this is the sixth reported case of TMP-SMX-associated rhabdomyolysis in an immunocompetent patient. This case highlights the need for clinicians to consider the potential for rhabdomyolysis in patients receiving TMP-SMX, regardless of their immune status, and to recognize that prompt withdrawal of the drug is critical for patient recovery.
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Role of Dual GIP and GLP-1 Receptor Agonist, Tirzepatide in the Management of Weight Loss; A Systematic Review
Available online: 31 October 2024More LessAimThe eventuality of tirzepatide, a binary GIP and GLP- 1 receptor agonist, as a treatment for rotundity and metabolic diseases is addressed in this comprehensive review.
BackgroundA definition of tirzepatide is that it is an implicit intervention for rotundity, given its effectualness per the cure-dependent effect. Beyond the beneficial effects on body weight loss, tirzepatide also brings about an improvement in lipid biographies and insulin perceptivity, in harmony with binary receptor activation.
MethodologyAssaying data from seven phases 3 trials, it's constantly shown that tirizepatide reduces body weight in a significant and clinically meaningful way for a variety of party biographies and lengths of time.
ResultsThe drug's effect was supported by its favorable safety profile, which shows low prevalence rates of common adverse goods. Its efficacy in the management of type 2 diabetes is supported by relative evaluations, underscoring the inevitability of its breakthrough as a therapeutic volition. Treatment individualization is key, as evidenced by the tailor-made response proposed by group analysis based on birth BMI. The efficacy, safety, and demand for personalized treatment plans of tirzepatide are each supported in recommendations for clinical practice.
ConclusionTirzepatide's eventuality as a long-term strategy for habitual rotundity is corroborated by long-term follow-up studies that show sustained weight loss. Indeed with these encouraging results, further study and clinical experience are demanded to completely comprehend the safety, optimal integration, and long-term effectiveness of tirzepatide in a multiplicity of patient populations.
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