Current Drug Safety (Volume 21 - Issue 1)

Rhabdomyolysis Following Trimethoprim-Sulfamethoxazole Therapy: A Case Report and Review of the Literature

2026-06-06

Background: Trimethoprim-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 Presentation: A 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.

Conclusion: To 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.

Comprehensive Review of Gestational Diabetes: Pathophysiology, Pharmacological Management and the Role of Pharmaceutical Care

2026-06-06

This 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.

Efficacy and Safety Profile of Suvorexant for the Treatment of Insomnia

2026-06-06

Insomnia 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.

Revealing the Future of Pharmacovigilance in Precision Pharmaceutical Monitoring

2026-06-06

The 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.

Self-Micro-Emulsifying Drug Delivery Systems: In-Depth Review on Enhancing Solubility and Therapeutic Efficacy of BCS Class II Drugs

2026-06-06

The 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.

Certolizumab-Induced Urticarial Vasculitis: A Case Report

2026-06-06

Introduction: Certolizumab (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 Presentation: A 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.

Conclusion: With the increasing use of CZ, physicians should be aware of the possibility of UV associated with CZ.

Linezolid Related Adverse Effects in Different Populations: A Review

2026-06-06

Linezolid, 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.

Tubulointerstitial Nephritis in ANCA-Associated Vasculitis as a Rare Adverse Effect of Adalimumab: A Case Report

2026-06-06

Background: Patients 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 Presentation: We 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.

Conclusion: Monitoring 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.

Preface

2026-06-06

A Case Series of Anaesthesia Mumps - Could Drugs be the Cause?

2026-06-06

Introduction: Acute parotid gland enlargement is an extremely rare post-surgical complication. Several etiological factors have been proposed, including preoperative dehydration, medications that cause an increase in viscosity of glandular secretions or loss of muscle tone and retrograde passage of air into the parotid glands, prolonged surgery, and operative position of the patient leading to pooling of secretions of the gland.

Case Representation: We present a series of two cases that developed bilateral enlargement of parotid glands post-operatively. Case 1 was a 30-year-old male who underwent a Trendelenburg operation with flush ligation and ligation of perforators for varicose veins of the right leg under spinal anaesthesia with bupivacaine. Fentanyl, midazolam, bupivacaine, and ondansetron were administered to the patient perioperatively. Case 2 was a 51-year-old female who underwent laparoscopic cholecystectomy for cholelithiasis under general anaesthesia. Fentanyl, midazolam, sevoflurane, and vecuronium were administered to this patient during the surgery. Both of these cases were managed conservatively by adequate hydration, antibiotics, and analgesics, and they recovered completely three days following the surgery.

Conclusion: The causative drug could not be well-established, but such cases stress that the surgeon, anesthetist, and patients should be aware of possibility of this adverse event. Postoperative anaesthesia mumps are usually of minimal clinical significance and resolve spontaneously with appropriate symptomatic care.

A Biochemical Investigation of the Prevalence of Hypercalcemia and Thiazide-Related Hypercalcemia in Patients

2026-06-06

Objective: Hypercalcemia 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).

Methods: This 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 (albumincorrected 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).

Results: Out 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).

Conclusion: TAH 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.

Advancements in Colon Cancer Therapy: A Review on Docetaxel and the Role of Nanotechnology in Enhancing Efficacy

2026-06-06

Docetaxel 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.

Cisplatin-Based Combinations-Associated Vasculopathy - A Disproportionality Analysis of Real-World Pharmacovigilance Data

2026-06-06

Introduction: Cisplatin, a platinum-based antineoplastic agent belonging to the alkylating class, is one of the most widely used chemotherapeutic agents in the treatment of solid tumors and hematologic malignancies. Cisplatin works by forming covalent bonds in DNA, resulting in cell cycle arrest, inadequate repair, and ultimately, apoptotic or non-apoptotic cell death. Despite its efficacy, cisplatin is known to be highly toxic, showing nephrological, Gastrointestinal (GI), and hepatotoxicity, but there is limited data on its association with adverse vascular events. Hence, we aimed to investigate the potential risk of drug-related adverse vascular events associated with four cisplatin-based combination therapies using the FDA Adverse Events Reporting System (FAERS).

Methods: We used the FDA Adverse Events Reporting System (FAERS) database to look for reported Adverse Events (AEs) for cisplatin-based combinations. In the current study, a case/non-case disproportionality analysis has been performed using the Reporting Odds Ratio (ROR) to investigate whether there is a signal for a potentially increased risk of drug-related vascular AE using the 2016-2020 FAERS datasets. To look for all vascular AEs, we included peripheral vascular events, cerebrovascular events, coronary artery-related events, venothromboembolic events, and other arterial events. “Cases” were defined as patients treated with cisplatin and any one of etoposide, gemcitabine, paclitaxel or docetaxel, and 5-fluorouracil or capecitabine, and have reported a composite event. Hence, cases were divided into 4 groups. Reporting Odds Ratio (ROR) and Information Component (IC) were derived to look for signals for these AEs being significant when compared to non-cases. All data processing and statistical analyses were performed using R 4.2.1.

Results: Between 2016 and 2020, 23,513 AEs were reported for patients who used cisplatinbased combinations, and 6,952,691 AEs in patients who did not. Baseline characteristics, including age, sex, and geographic distribution, were also reported. Looking at ROR and IC, all 4 groups showed statistically significant vasculopathies reported for cisplatin-based combinations, except for cisplatin and paclitaxel/docetaxel where there was a trend in ROR, but it did not reach statistical significance. It also gave the least signal for associated vasculopathy, while cisplatin and gemcitabine gave the highest signal with both ROR and IC for associated vasculopathy.

Conclusion: Overall, these increased vasculopathies related to the use of cisplatin-based combinations can be related to the increased pro-thrombotic state in these patients. The results of this study highlight the need for caution when using cisplatin-based chemotherapy and the importance of monitoring patients for thrombotic events and other vasculopathies. Patient-specific factors, such as the type and stage of cancer, should be considered when determining the best treatment option and managing the risk of vascular complications.