Current Drug Safety[JOURNAL]
Sun
200 papers
Transdermal Drug Delivery Systems: Integrating Modern Technology for Enhanced Therapeutics.
Kathuria T, Saharan R, Dhankhar S … +6 more , Mahajan S, Beniwal SK, Chauhan S, Dahiya P, Verma I, Yasmin S
Curr Drug Saf · 2025 Feb · PMID 39931994 · Publisher ↗
BACKGROUND: In recent years, transdermal drug delivery systems (TDDS) have gained popularity as a non-invasive, patient-friendly medication delivery method. OBJECTIVE: This review article examines the latest transdermal...
BACKGROUND: In recent years, transdermal drug delivery systems (TDDS) have gained popularity as a non-invasive, patient-friendly medication delivery method. OBJECTIVE: 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. METHODS: A 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. RESULTS: Transdermal 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. CONCLUSION: The 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.
Extreme and Severe Systemic Pain Caused by Rifampicin: A Case Report of a Rare Allergic Reaction.
Li TX, Xiong YM, Gao WW … +5 more , Jiang B, He Y, He S, Xu L, Yang S
Curr Drug Saf · 2025 · PMID 39931993 · Publisher ↗
BACKGROUND: Rifampicin is a first-line anti-tuberculosis drug, but it may cause severe allergic adverse reactions. CASE PRESENTATION: This case report describes an unusual and severe adverse reaction to rifampicin in a 5...
BACKGROUND: Rifampicin is a first-line anti-tuberculosis drug, but it may cause severe allergic adverse reactions. CASE PRESENTATION: This case report describes an unusual and severe adverse reaction to rifampicin in a 53-year-old male patient with pulmonary tuberculosis. The patient developed intense systemic pain within 4 hours of rifampicin administration, affecting multiple organs and joints, without typical allergic manifestations, such as fever or rash. The pain progressively worsened over three consecutive days of treatment, reaching its peak intensity (NRS score 8/10) on the third day with pain duration extending from 3 to 8 hours. The severe pain was characterized as sharp and burning in nature, significantly impacting the patient's daily activities and mobility. A subsequent rifampicin challenge test (single dose 0.45g) confirmed the causal relationship by reproducing identical severe pain symptoms. The Naranjo adverse drug reaction probability scale yielded a score of 7, indicating a "probable" causal relationship. Notably, the patient exhibited underlying autoimmune abnormalities (positive ANA and elevated ESR), which may have contributed to the severity of the reaction through enhanced inflammatory responses and altered pain mechanisms. The symptoms completely resolved upon rifampicin discontinuation, and alternative treatment with levofloxacin proved successful with no pain recurrence during the fourmonth follow-up period. CONCLUSION: This case highlights a previously unreported presentation of rifampicin hypersensitivity and emphasizes the importance of careful risk assessment in patients with autoimmune features before initiating rifampicin therapy.
Comprehensive Review of Gestational Diabetes: Pathophysiology, Pharmacological Management and the Role of Pharmaceutical Care.
Abdu A, Bakrey H
Curr Drug Saf · 2025 Jan · PMID 39901685 · Publisher ↗
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...
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.
Rhabdomyolysis Following Trimethoprim-Sulfamethoxazole Therapy: A Case Report and Review of the Literature.
Salem MY, Fatma Z, Israa D … +4 more , Widd K, Sarrah K, Imen A, Sihem EA
Curr Drug Saf · 2025 Jan · PMID 39886787 · Publisher ↗
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....
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.
Reported Postoperative Surgical Site Infections in Tertiary Care Hospitals, Systematic Review of Recent Literature.
Nadeem S, Hameed AA, Gillani SW … +1 more , Rathore HA
Curr Drug Saf · 2025 · PMID 39878115 · Publisher ↗
PURPOSE: The objective of this systematic review is to evaluate the patterns of postsurgical site infections, pre-surgical antibiotics prophylaxis, and related clinical outcomes in the recently published literature. METH...
PURPOSE: The objective of this systematic review is to evaluate the patterns of postsurgical site infections, pre-surgical antibiotics prophylaxis, and related clinical outcomes in the recently published literature. METHODS: This systematic review is registered with PROSPERO registration number CRD42023398963. Several databases and individual journal websites were used to collect data from PubMed/Medline, TRIP, SCOPUS, Elsevier, Springer, ProQuest, and EMBASE. The established criteria of inclusion were RCTs, retrospective, prospective, and cross-sectional studies with patients who had a recent surgical procedure. Excluded from the study designs were systematic reviews, prospective studies, data on pediatrics, and data on disabilities. Quality assessment analysis of the results for randomized controlled trials (RCT) used CONSORT guidelines and STROBE guidelines for cross-sectional and cohort studies. RESULTS: A total of 328 articles were identified from different databases. Among them, 15 studies were included for data extraction and qualitative analysis. A total of 33,193 patients with an average rate of 11.5% (surgical site infections- SSIs) were identified in these studies during 2008-2022. The mean rate of SSIs among the total number of immunocompromised patients/ procedures was 10.2%. The SSI on patients undergoing major surgical procedures with visible incisions was 26.0%. The majority of the studies reported the use of pre-surgical antibiotic prophylaxis. Cefazolin was mostly prescribed antibiotics and administered in 90% of patients. Other antibiotics included ceftriaxone (4%), cloxacillin (3%), and vancomycin (4%). The mean reported rate of SSIs with combination antibiotic prophylaxis therapy was 22.8%. CONCLUSION: This systematic review concluded the limited reported data on surgical site infections (SSIs). The overuse of pre-surgical antibiotic prophylaxis has been reported in several studies. This study recommended developing standardized guidelines on the use of antibiotics related to surgical cases rather than co-morbidities.
Clomipramine-Induced Urinary Retention in an Adult Male - A Case Report.
Mehta P, Sapovadia P, Purohit B
Curr Drug Saf · 2025 · PMID 39878114 · Publisher ↗
BACKGROUND: Clomipramine, a Tricyclic Antidepressant (TCA), is known for its efficacy in treating Obsessive-Compulsive Disorder (OCD). However, it is associated with several side effects, including urinary retention. Thi...
BACKGROUND: Clomipramine, a Tricyclic Antidepressant (TCA), is known for its efficacy in treating Obsessive-Compulsive Disorder (OCD). However, it is associated with several side effects, including urinary retention. This case report discusses the case of a 20-year-old male with OCD who developed urinary retention following clomipramine administration. CASE REPRESENTATION: A 20-year-old male with a one-year history of OCD with psychotic features was admitted to SIR-T Hospital, Bhavnagar, due to worsening symptoms. He was prescribed clomipramine along with other psychotropic medications. On the 16th day of hospitalization, the patient experienced acute urinary retention, necessitating catheterization. Clomipramine dosage was subsequently reduced, resulting in the resolution of urinary retention. The patient was discharged after 29 days with no further urinary complications. DISCUSSION: The causality assessment suggested a probable link between clomipramine and urinary retention, supported by the Naranjo Scale, WHO-UMC criteria, and literature. The anticholinergic properties of clomipramine likely contributed to the condition. Despite its side effects, clomipramine remains a valuable treatment for OCD, requiring careful dose management to mitigate adverse effects. CONCLUSION: Clinicians should be vigilant for urinary retention in patients receiving clomipramine, especially at higher doses. Regular monitoring and dose adjustments are crucial for managing this side effect without compromising the therapeutic benefits for OCD.
Efficacy and Safety of Adding 1 μg/Kg Dexmedetomidine to 20 ml Bupivacaine in Supraclavicular Brachial Plexus Block: A Randomized Trial.
Ghoniem BM, Shams GH, Abdelsalam W … +1 more , Elsharkawy MF
Curr Drug Saf · 2025 · PMID 39835564 · Publisher ↗
BACKGROUND: For surgical procedures of the upper limbs, ultrasound-guided supraclavicular brachial plexus block (SCBPB) represents a safe substitute for general anesthesia. The present study evaluated the effectiveness a...
BACKGROUND: For surgical procedures of the upper limbs, ultrasound-guided supraclavicular brachial plexus block (SCBPB) represents a safe substitute for general anesthesia. The present study evaluated the effectiveness and safety of incorporating 1μg/kg dexmedetomidine (DEX) into 20 ml bupivacaine, as opposed to using 20 ml and 30 ml bupivacaine without additives, in SCBPB. METHODS: This randomized, controlled, double-blind study included 75 patients assigned to elective upper-limb surgery under the mid-humerus level. Patients were randomized into three equal groups to receive US-guided SCBPB with 20 ml bupivacaine 0.5% + 1 μg/kg DEX in group BD, 20 ml bupivacaine 0.5% without additives in group B20, and 30 ml bupivacaine 0.5% in group B30 (control). RESULTS: Compared to group B20, groups BD and B30 had significantly quicker onset times for sensory and motor blocks. Groups BD and B30 had a more significant block duration than group B20. Group BD experienced considerably lower intraoperative hemodynamics than groups B20 and B30. Groups BD and B30 had a significantly delayed time to first rescue analgesia and consumed less pethidine than group B20. Compared to group B20, the pain score was significantly reduced in groups BD and B30. Comparable levels of pain score, rescue analgesia time, total pethidine consumption, and motor and sensory block onset and duration were seen in the BD and B30 groups. CONCLUSION: DEX with a lower volume (20 ml) of bupivacaine reaches the same result as a higher volume of bupivacaine (30 ml) in managing perioperative pain and hemodynamic stability without the risk of the high volume of bupivacaine. Further, adding DEX to small dose of bupivacaine (20 ml) is more effective than small dose of bupivacaine (20 ml) alone without additives in prolonging the duration of sensory and motor block, reducing pain intensity, and delaying the need for rescue analgesia.
A Rare Case of Fatal Toxic Epidermal Necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome in a Patient with Rheumatoid Arthritis.
Munshi R, Sachdeo P, Solanki V
Curr Drug Saf · 2025 · PMID 39812037 · Publisher ↗
INTRODUCTION: This case study presents a rare and fatal instance of Toxic Epidermal Necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome in a 51-year-old male patient diagnosed with...
INTRODUCTION: This case study presents a rare and fatal instance of Toxic Epidermal Necrolysis (TEN) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome in a 51-year-old male patient diagnosed with Rheumatoid Arthritis (RA). CASE PRESENTATION: The patient was initially treated with sulfasalazine, leflunomide, and hydroxychloroquine, following which he developed a rash, fever, and loose stools. Drug allergy was suspected, and the anti-rheumatic medications were withdrawn, following which, the patient improved. A subsequent attempt was made to treat the RA with methotrexate, prednisolone, and hydroxychloroquine, following which the rash returned along with an increase in severity, including detachment of the epidermis and mucosa, and systemic involvement, both hepatic and renal. The patient ultimately succumbed to multiple organ dysfunction syndrome and neutropenic sepsis. CONCLUSION: This case highlights the possibility of DRESS syndrome and Stevens-Johnson Syndrome (SJS)/TEN following treatment with anti-rheumatic medications. Evidence of this is rare, with the exception of sulfasalazine. This case also considers that the signs of a moderately severe adverse drug reaction could be the early warning signs of DRESS syndrome, which can be difficult to manage and may turn fatal. Additionally, this case highlights the need for maintenance of quality health records in low- and middle-income countries due to the failure to identify hydroxychloroquine as a suspected drug inducing the initial adverse reaction that resulted in it being prescribed again, leading to a fatal outcome.
DRESS Mimicking Flushing Syndrome Associated with Vancomycin: A Case Report.
Khanth P E S, Thangaraju P, Gaikwad NR … +1 more , Wasnik PN
Curr Drug Saf · 2025 · PMID 39781732 · Publisher ↗
BACKGROUND: The Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a serious adverse reaction that occurs weeks after the onset of drug exposure. DRESS syndrome is commonly associated with antiseizure drugs...
BACKGROUND: The Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is a serious adverse reaction that occurs weeks after the onset of drug exposure. DRESS syndrome is commonly associated with antiseizure drugs, sulfa drugs, and antibiotics. CASE PRESENTATION: This was a case report of a 20-year-old female who suffered from DRESS due to vancomycin with symptoms similar to the Redman syndrome. The patient was a case of Infective endocarditis due to methicillin-resistant (MRSA), and vancomycin was intravenously administered. On the 18th day, during the administration of vancomycin, the patient developed sudden severe flushing over the face and trunk. The offending drug was suspended and treated with antihistamines in view of Redman syndrome. Later, the patient developed uncontrolled fever, desquamating rash all over the body, severe pruritis, and eosinophilia. On applying the RegiScar score, a probable case of DRESS was diagnosed. The patient was managed symptomatically and discharged. DISCUSSION: The clinical presentation of DRESS includes skin rash, fever, eosinophilia, and organ involvement. But, in this case, there was a varied initial presentation of DRESS with severe flushing, which mimics the Redman syndrome due to vancomycin. Difficulty in establishing organ involvement remained a challenge in diagnosing DRESS. CONCLUSION: DRESS can have a varied clinical presentation. Careful monitoring of all vital parameters is important in preventing the misdiagnosis of DRESS syndrome.
Adverse Events Associated with Antivirals for COVID-19: An Analysis Based on FDA Adverse Event Reporting System (FAERS).
Radzuan MISM, Karuppannan M
Curr Drug Saf · 2025 · PMID 39773068 · Publisher ↗
BACKGROUND: The COVID-19 pandemic has called for the rapid development and use of antiviral drugs to effectively control the disease. Nirmatrelvir/Ritonavir (Paxlovid), Molnupiravir, and Remdesivir have been pivotal in t...
BACKGROUND: The COVID-19 pandemic has called for the rapid development and use of antiviral drugs to effectively control the disease. Nirmatrelvir/Ritonavir (Paxlovid), Molnupiravir, and Remdesivir have been pivotal in therapeutic approaches, although they raise concerns regarding adverse drug reactions (ADRs). OBJECTIVE: This study aimed to thoroughly assess the ADRs associated with these drugs by utilizing the Adverse Event Reporting System (FAERS) database of the Food and Drug Administration (FDA). METHODS: ADR reports for Paxlovid, Molnupiravir, and Remdesivir throughout the period of January 2022 to May 2023 were extracted and classified according to the severity, type of reaction, and demographic variables. Reporting Odds Ratios (RORs) with 95% confidence intervals were calculated to evaluate the relationship between antiviral medications and various ADRs. RESULTS: The study established notable correlations between Paxlovid and the recurrence of the disease (40.08%) and dysgeusia (16.29%). Molnupiravir was linked to gastrointestinal (16.73%) and skin reactions (9.47%), while Remdesivir had impairments in the liver (25.21%) and kidneys (13.34%). ADRs were more commonly observed in female patients treated with Paxlovid (57.95%) and Molnupiravir (49.40%), whereas Remdesivir ADRs were mostly reported in males (58.56%). Paxlovid and Remdesivir ADRs were frequently reported in adults between the ages of 18 and 64 (46.01% and 45.01%), while Molnupiravir ADRs were more common in older individuals aged 65 to 85 (40.38%). CONCLUSION: This thorough assessment emphasizes the importance of careful surveillance and control of ADRs linked to COVID-19 antiviral therapies. It is essential to customize treatments by considering specific patient histories, particularly for pre-existing diseases.
Mycophenolate Mofetil Induced-Colitis: Is it More about Clinical Diagnosis?
Nagandran Y, Mandal S, Zahar AZ
Curr Drug Saf · 2025 · PMID 39757679 · Publisher ↗
BACKGROUND: Mycophenolate mofetil (MMF) is an immunosuppressant commonly used for treating autoimmune diseases. CASE PRESENTATION: We report a diagnostically challenging case of MMF-induced colitis in a patient after 3 y...
BACKGROUND: Mycophenolate mofetil (MMF) is an immunosuppressant commonly used for treating autoimmune diseases. CASE PRESENTATION: We report a diagnostically challenging case of MMF-induced colitis in a patient after 3 years of initiation of MMF therapy. A 76-year-old Caucasian female with a history of chronic inflammatory demyelinating polyneuropathy receiving MMF presented to the hospital with a 7-weeks history of watery diarrhoea and crampy abdominal pains. Routine blood investigations, CMV-PCR, stool culture, viral PCR, Colonoscopy, and CT scan of the abdomen were broadly within normal limits. Histopathological changes were not significantly diagnostic apart from ischaemic-type changes. Finally, the reduction of the MMF dose caused the cessation of diarrhoea. Diagnosing MMF-induced colitis can be challenging, especially in patients on immunosuppressive medications. Further, long latency periods and non-specific colonoscopic and histopathologic changes add to the diagnostic dilemma. CONCLUSION: MMF-induced diarrhoea should be part of the clinician's differentials, and the decision to reduce the dose of MMF needs to be considered once infection and other causes have been ruled out.
The Presence of Nitrosamines and Nitrosamine Drug-Related Substances in Pharmaceutical Products: An Overview of Regulatory Concerns, Analytical Methodologies, and Control Strategies.
Dhansekar N, Rale P, Ghalsasi Y
Curr Drug Saf · 2025 · PMID 39754761 · Publisher ↗
The presence of N-nitrosamine impurities in pharmaceutical products is well known. In 2019, it resulted in drug recall by the Food and Drug Administration (FDA). Soon, several groups identified the presence of many N-nit...
The presence of N-nitrosamine impurities in pharmaceutical products is well known. In 2019, it resulted in drug recall by the Food and Drug Administration (FDA). Soon, several groups identified the presence of many N-nitrosamines (NAs) in various Active Pharmaceutical Ingredients (APIs) and drug formulations worldwide. Moreover, in the last two years, another type of NAs was identified and detected in several pharmaceutical products. These are easily formed from the parent drug molecule and are known as Nitrosamine drug-related substances (NDSRIs). The amine group plays a major and unique role in the synthesis of many drug molecules, and hence, it is practically impossible to eliminate the presence of NAs and NDSRIs from drug products. The risk assessment of the health hazard to the patient was done, and the FDA has set the maximum daily acceptable intake (AI) at 18 ng/day for NAs. This limit poses a significant challenge in isolating, identifying and quantifying NAs and NDSRIs in APIs and formulations. For small, simple NAs, a lot of toxicological information and carcinogenetic data is available; however, for NDSRIs, such data is practically absent. This review article attempts to gather the toxicological data for a few NAs and NDSRIs and tries to assess the genotoxicity potential of some NDSRIs. The possible sources of NAs and NDSRIs, including synthetic methodology and processes, impurities associated with intermediates or raw materials, stability of the API, packaging materials, imprinting inks, and excipients, are also discussed. A summary of different analytical techniques used for the detection of these NAs and NDSRIs in different pharmaceutical products has also been included. Finally, various strategies employed for the minimization of these impurities along with additional control strategies to mitigate NAs and NDSRIs below acceptable limits, have also been discussed.
Vorasidenib: A Milestone in Targeted Therapy for IDH-Mutant Lower Grade Gliomas - Efficacy, Emerging Safety Concerns, and the Call for Comprehensive Safety Evaluation.
Yoosuf BT, Pattanayak M, Sah S
Curr Drug Saf · 2025 · PMID 39679466 · Publisher ↗
Abstract loading — click title to view on PubMed.
SGLT-2 Inhibitors as an Effective Treatment for Type 2 Diabetes Mellitus, Hypertension, and Hyperuricemia - A Mechanistic Perspective.
Rashid SA, Balasubramanian R, Maideen NMP
Curr Drug Saf · 2025 · PMID 39582224 · Publisher ↗
Abstract loading — click title to view on PubMed.
Carbamazepine-induced Stevens-Johnson Syndrome: A Case Report with Review of the Literature.
Subramanian A, Haitharali R, Nirenjen S … +5 more , Tamilanban T, Dhanasekaran S, Gnanasekaran S, Manavalan M, Raja S
Curr Drug Saf · 2025 · PMID 39506448 · Publisher ↗
BACKGROUND: Stevens-Johnson Syndrome (SJS) is an infrequent yet severe mucocutaneous reaction that involves less than 10% of the Body Surface Area (BSA). It is predominantly induced by certain medications, including anti...
BACKGROUND: Stevens-Johnson Syndrome (SJS) is an infrequent yet severe mucocutaneous reaction that involves less than 10% of the Body Surface Area (BSA). It is predominantly induced by certain medications, including anticonvulsants (e.g., Lamotrigine, Carbamazepine, Phenytoin, Phenobarbitone), Allopurinol at doses above 100 mg per day, and sulphonamides (e.g., Cotrimoxazole, Sulfasalazine). Genetic predispositions, particularly the presence of the HLA-B*1502 allele, significantly increase the risk of developing SJS. This case report discusses a unique presentation of SJS in a young female patient, emphasizing the critical need for genetic screening and careful monitoring when prescribing Carbamazepine, especially in populations at higher genetic risk. CASE PRESENTATION: A 19-year-old female patient, who had been on Phenytoin and Sodium Valproate for epilepsy management over the past year, was newly prescribed Carbamazepine. Within a week of initiating Carbamazepine, the patient experienced a seizure, followed by the sudden onset of fever, painful sores, and blisters covering the upper body, along with mucous discharge from both eyes. These symptoms rapidly worsened. Based on clinical presentations and the extent of epidermal detachment, the patient was diagnosed with SJS. The severity and mortality risks were assessed using the SCORTEN score. Therapeutic interventions included intravenous Ranitidine, Ondansetron, Paracetamol, Midazolam, Levetiracetam, and Dexamethasone, along with oral Fluconazole, Chlorpheniramine tablets, and Ciprofloxacin eye drops. The patient showed significant improvement and was discharged after fourteen days with followup advice. CONCLUSION: This case underscores the critical importance of performing genetic testing for the HLA-B*1502 allele and conducting baseline blood tests before initiating Carbamazepine therapy. Such precautionary measures can significantly mitigate the risk of severe adverse reactions like SJS. This report adds to the scientific literature by highlighting the potential dangers associated with anticonvulsant therapies and the necessity for personalized medicine approaches in preventing life-threatening conditions. The main takeaway is the pivotal role of genetic screening and vigilant monitoring in the management of patients requiring anticonvulsant medications to prevent serious adverse reactions.
Facial Hyperpigmentation Following Adalimumab.
Salem MY, Imen A, Israa D … +3 more , Fatma Z, Ons C, Sihem EA
Curr Drug Saf · 2025 · PMID 39484757 · Publisher ↗
BACKGROUND: Tumor necrosis factor alpha (TNF-α) inhibitors, such as adalimumab, have significantly advanced the treatment of inflammatory diseases. However, these therapies are associated with various cutaneous adverse r...
BACKGROUND: Tumor necrosis factor alpha (TNF-α) inhibitors, such as adalimumab, have significantly advanced the treatment of inflammatory diseases. However, these therapies are associated with various cutaneous adverse reactions. CASE PRESENTATION: We describe two rare instances of isolated facial hyperpigmentation induced by adalimumab. Both patients presented with asymptomatic, isolated brown macules on the cheeks following adalimumab treatment for ankylosing spondylitis. The hyperpigmentation appeared shortly after starting the medication in both cases. In one case, the hyperpigmentation persisted despite stopping the medication, while in the second case, it completely resolved within one month after discontinuation. However, in the second patient, the hyperpigmentation recurred after switching to certolizumab, another TNF-α inhibitor. No skin biopsies were performed, and both patients were otherwise healthy, with normal laboratory evaluations. CONCLUSION: Hyperpigmentation is an uncommon adverse reaction of this class of drugs, with only a few reported cases in the literature. The recurrence of hyperpigmentation after switching to another TNF-α agent, certolizumab, further suggests that this reaction may be a class effect, adding new insights into the spectrum of cutaneous side effects associated with TNF-α inhibitors. Clinicians should consider this potential side effect in patients presenting with hyperpigmentation, and sun protection should be recommended as a preventive measure.
Role of Dual GIP and GLP-1 Receptor Agonist, Tirzepatide in the Management of Weight Loss; A Systematic Review.
Rangraze IR, Khan S, Wali AF … +3 more , Menezes G, Goud M, Jabran M
Curr Drug Saf · 2024 Oct · PMID 39484756 · Publisher ↗
INTRODUCTION: Tirzepatide, a dual GIP and GLP-1 receptor agonist, is a promising therapeutic option for obesity and metabolic disorders. METHODS: Systematic review following PRISMA guidelines across PubMed, Embase, and C...
INTRODUCTION: Tirzepatide, a dual GIP and GLP-1 receptor agonist, is a promising therapeutic option for obesity and metabolic disorders. METHODS: Systematic review following PRISMA guidelines across PubMed, Embase, and Cochrane. Included RCTs and observational studies. RESULTS: Seven phase 3 trials showed significant, dose-dependent reductions in body weight and improvements in metabolic markers. Well-tolerated, with low rates of hypoglycemia. Subgroups with higher BMI had greater benefits. DISCUSSION: Demonstrates consistent efficacy and safety across diverse populations; personalized approaches may optimize outcomes. CONCLUSION: Tirzepatide is effective, safe, and durable in managing obesity and metabolic disorders; long-term studies warranted.
A Retrospective Observational Study of Adverse Drug Reactions (ADR) Reported to ADR Monitoring Centre from 2010 to 2020.
Srinivasan A, Selvarajan S, Shivabasappa S … +1 more , Arunmozhy S
Curr Drug Saf · 2025 · PMID 39440781 · Publisher ↗
BACKGROUND: Adverse Drug Reactions (ADR) are one of the common causes of hospital admissions and pose a significant clinical and economic burden on the healthcare system. The Adverse Drug Reaction Monitoring Centre (AMC)...
BACKGROUND: Adverse Drug Reactions (ADR) are one of the common causes of hospital admissions and pose a significant clinical and economic burden on the healthcare system. The Adverse Drug Reaction Monitoring Centre (AMC) in JIPMER functioning under the Pharmacovigilance Programme of India (PvPI) plays a vital role in ensuring medication safety by routinely detecting and monitoring ADRs. Hence, this study aimed to assess the characteristics of ADR reported from 2010 to 2020 in AMC JIPMER and to detect signals, if any. OBJECTIVE: To study the characteristics of Adverse Drug Reactions (ADR) reported to a regional ADR monitoring center from 2010 to 2020 and to detect signals of disproportionate reporting (SDRs) if any from the reported ADRs. MATERIALS AND METHODS: A total of 6007 ADR reports with a single suspect drug were included for analysis from 2010 to 2020. The characteristics of these reports, including patient's age and gender, Number and percentage of ADRs, the causality of ADR using WHO UMC (World Health Organization-Uppsala Monitoring Centre) scale, the seriousness of the ADR, and outcome were collected from the ADR reports. MedDRA (Medical Dictionary for Regulatory Activities) Preferred Terms (PT) were used to classify adverse drug reactions. Causality analysis using the Naranjo Algorithm and Preventability using Modified Schumock and Thornton criteria were performed for the ADRs. The number and percentage of severe ADRs were analyzed. The System Organ class of all the ADRs was enumerated. ADRs not mentioned in the US FDA (United States Food and Drug Administration) product label (unlabelled reactions) were documented. Unlabeled reactions with ≥3 ADR reports were included for signal detection by disproportionality analysis. RESULTS: Antineoplastic drugs, followed by antimicrobials, anticonvulsants, Anti snake venom, and NSAID were the most common drugs implicated in ADRs. Skin and subcutaneous tissue disorders were the most common System Organ Class (SOC) involved in the ADRs. Among the 6007 reports, 19.2% were serious ADRs. Most of the ADR reports were of possible causality followed by probable and certain as per WHO UMC and Naranjo causality scales. Only ten ADRs were preventable and one reaction (Tamoxifen-induced neuropathy) was eligible for signal detection. Disproportionality analysis using a 2x2 contingency table showed insignificant signal detection using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). CONCLUSION: Analysis of ADRs from an ADR Monitoring center functioning in a tertiary care hospital shows antineoplastic drugs to be the most common drugs associated with adverse drug reactions, with rash being the most common adverse effect. The majority of the ADRs were not preventable. No Signals of Disproportionate Reporting (SDR) were detected in our study.
A Review of Published Cases Regarding the Amphotericin B Deoxycholate Overdose in the Pediatric Population and a Case Report.
Shahrabi M, Savadi S, Tavakolifar Y … +1 more , Solduzian M
Curr Drug Saf · 2025 · PMID 39415586 · Publisher ↗
Considering the fact that two available and commonly used formulations of amphotericin B could be used instead of each other by mistake. Also, an updated and comprehensive data regarding management of this medication err...
Considering the fact that two available and commonly used formulations of amphotericin B could be used instead of each other by mistake. Also, an updated and comprehensive data regarding management of this medication error was not available; the current review was conducted to gather available data among the pediatric population and discuss management and outcome of patients in case such an error occurs. We review all the cases of amphotericin B overdose which reported in PubMed and google scholar so far then discuss an 8-years-old girl diagnosed with Ewing sarcoma who inadvertently received five times more than therapeutic dose of amphotericin B deoxycholate (5mg/kg/day).In total, ten of the cases were exactly matched to our purpose of the study. In our case, fluid and electrolyte management was aggressively undertaken and she was put under cardiac monitoring for 7 days following detection of the medication error. Finally, she was discharged from hospital with stable condition. Reviewed data in this manuscript showed that amphotericin B deoxycholate overdose could cause severe complications and lead to cardio toxicity, electrolyte imbalance and death. Aggressive cardiac, fluid and electrolyte monitoring and management of any problem as soon as they were detected was the pathway followed by the authors of this review and others who faced this medication error. The role of NAC and hydrocortisone in the managing amphotericin B deoxycholate overdose requires further investigation.
Resveratrol Neuroprotective Action Against Cognitive Impairments Induced by Lorazepam in Male Rats.
Chakraborty AK, Tiwari P, Khobragade DS … +3 more , Kadiri SK, Sheikh IA, Thakur J
Curr Drug Saf · 2025 · PMID 39410894 · Publisher ↗
INTRODUCTION/AIM: The study examines how chronic resveratrol administration affects behavioral and neurochemical changes caused by Lorazepam (LZP), a classical anti-anxiety medicine associated with neurodegenerative and...
INTRODUCTION/AIM: The study examines how chronic resveratrol administration affects behavioral and neurochemical changes caused by Lorazepam (LZP), a classical anti-anxiety medicine associated with neurodegenerative and neurological problems. METHOD: Forty male rats were placed into four groups: a control group receiving 1% Tween 80, the LZP group receiving 2 mg/kg/day, the Resveratrol group receiving 50 mg/kg/day, and the LZP plus resveratrol group receiving the same doses of LZP and Resveratrol. Oral therapy was given daily for 6 weeks. The animals were euthanized after open field and Y maze behavioral tests. In specific brain regions, neurochemical analyses were performed on GABA, glutamic acid, monoamines (norepinephrine, dopamine, and serotonin) and their metabolites, DNA fragmentation (8-hydroxy-2-deoxyguanosine or 8-HdG), brain-derived neurotrophic factor (BDNF), and Ca-ATPase. RESULTS: Resveratrol therapy improved GABA, glutamic acid, monoamines, and their metabolites in the cerebral cortex, hippocampus, and striatum. Additionally, it reduced DNA fragmentation (8- HdG) and counteracted LZP-induced Ca-ATPase downregulation at a significant level (p < 0.05). Resveratrol also reversed LZP-induced behavioral changes in the Y maze and open field tests. CONCLUSION: Resveratrol has anxiolytic-like actions like benzodiazepines and neuroprotective capabilities against LZP-induced adverse effects.
About
- Frequency
- Sun
- Papers found
- 200
- RSS feed
- Subscribe