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Open AccessArticle

Disproportionality Analysis of Hematologic Adverse Event Signals Associated with Venetoclax in Combination with Senescence-Inducing Chemotherapy

by Tareq Saleh, Mohannad Ramadan, Anoud Alsoud and Sofian Al Shboul

J. Clin. Med. 2026, 15(6), 2194; https://doi.org/10.3390/jcm15062194 - 13 Mar 2026

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Abstract

Background: BH3 mimetics (such as venetoclax and navitoclax) are increasingly investigated in the context of the “one-two punch” anticancer strategy, wherein senescence-inducing therapies are combined with senolytic clearance. However, real-world pharmacovigilance evidence describing hematologic adverse event (AE) patterns and serious outcomes for [...] Read more.

Background: BH3 mimetics (such as venetoclax and navitoclax) are increasingly investigated in the context of the “one-two punch” anticancer strategy, wherein senescence-inducing therapies are combined with senolytic clearance. However, real-world pharmacovigilance evidence describing hematologic adverse event (AE) patterns and serious outcomes for venetoclax versus navitoclax in such combination settings remains limited. This study aims at providing an expectation based on the current reporting of the safety implications of senolytics combined with senescence-inducing therapy in clinical practice. Methods: We analyzed de-duplicated U.S. FDA Adverse Event Reporting System (FAERS) reports retrieved on 1 August 2025. Venetoclax reports (Q2 2016–Q2 2025) were categorized as monotherapy or combination with senescence-inducing chemotherapy (predefined based on published evidence of therapy-induced senescence [TIS]). Hematologic AEs were grouped into three categories (isolated low WBC, isolated low platelet count, and multi-lineage cytopenia). Disproportionality analyses were conducted using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) with 95% CIs and chi-squared testing. Navitoclax reports were analyzed descriptively due to limited volume. Results: A total of 47,508 venetoclax reports were included (34,485 monotherapy; 13,023 combination). Compared with monotherapy, combination therapy showed disproportionate reporting signals (ROR/PRR; reflecting reporting disproportionality rather than incidence or causal risk) for low WBC (ROR 2.87, PRR 2.59) and multi-lineage cytopenias (ROR 3.54, PRR 2.94), while isolated low platelet count was under-represented (ROR 0.31, PRR 0.32). For outcomes, combination therapy demonstrated higher reporting signals for life-threatening outcomes (ROR 7.06, PRR 6.56), hospitalization (ROR 1.74, PRR 1.39), and other outcomes (ROR 2.36, PRR 1.57), while death (ROR 0.55, PRR 0.65) and non-serious outcomes (ROR 0.26, PRR 0.29) were proportionally less reported (all p < 0.001). Navitoclax had 172 reports; hematologic cytopenias and serious outcomes were frequent, but analyses were descriptive only. Conclusions: In FAERS, venetoclax combined with senescence-inducing chemotherapy shows stronger reporting signals for leukopenia and multi-lineage cytopenias and for several serious outcome categories compared with monotherapy. These reporting patterns highlight the need for further care in terms of clinical implementation of the currently investigated senolytics prior to the consideration of the “one-two punch” strategy. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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12 pages, 436 KB

Open AccessArticle

Immediate-Type PPI Hypersensitivity as a Severe Adverse Drug Reaction: Diagnostic Challenges, Cross-Reactivity, and Real-Life Outcomes

by Ragıp Fatih Kural, Ceyda Tunakan Dalgıç, Yusuf Özeke, Kasım Okan, Salih Afşin, Reyhan Gümüşburun, Kutay Kırdök, Züleyha Galata, Meryem İrem Toksoy Şentürk, Ümitcan Ateş, Eda Aslan, Emine Nihal Mete Gökmen and Aytül Zerrin Sin

J. Clin. Med. 2026, 15(5), 1808; https://doi.org/10.3390/jcm15051808 - 27 Feb 2026

Cited by 1 | Viewed by 610

Abstract

Background/Objectives: Immediate-type hypersensitivity reactions (HSRs) to proton pump inhibitors (PPIs) represent a clinically relevant adverse drug reaction and pose diagnostic and management challenges, including variable cross-reactivity (CR). Drug provocation testing (DPT) is the diagnostic gold standard, but real-life use after testing remains [...] Read more.

Background/Objectives: Immediate-type hypersensitivity reactions (HSRs) to proton pump inhibitors (PPIs) represent a clinically relevant adverse drug reaction and pose diagnostic and management challenges, including variable cross-reactivity (CR). Drug provocation testing (DPT) is the diagnostic gold standard, but real-life use after testing remains uncertain. This study aimed to describe clinical features, diagnostic outcomes, CR profiles, and real-life PPI use in patients with immediate-type PPI hypersensitivity. Methods: Single-center ambispective study of 40 patients evaluated for immediate-type PPI HSRs (2014–2023). Index reactions, culprit PPI, and skin test/DPT results were recorded retrospectively. Patients tolerating an alternative PPI on DPT were followed prospectively; real-life tolerance and use were assessed by structured telephone interview. Results: Among 40 patients (87.5% female; mean age 48 years), lansoprazole was the most frequent culprit (50%); anaphylaxis occurred in 65%. Skin tests were positive in 25% (n = 9), and a shorter interval from reaction to testing was associated with positivity (p = 0.025). CR was detected in 25% (n = 10), most often between lansoprazole and pantoprazole. All 29 patients undergoing DPT tolerated at least one alternative PPI. In real-life follow-up (n = 27), 11 (40.7%) restarted PPIs without recurrence; 1 (3.7%) developed a mild cutaneous reaction despite negative testing. Fifteen (55.6%) did not restart therapy; 4 (14.8%) cited drug-related anxiety or physician-advised avoidance. Conclusions: In immediate-type PPI hypersensitivity, skin test sensitivity appears time-dependent, supporting early evaluation. DPT identifies safe alternatives, yet behavioral and clinician-related barriers limit real-life implementation; addressing these barriers is essential to optimize PPI allergy management. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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13 pages, 744 KB

Open AccessArticle

Proton Pump Inhibitors and Disproportionate Reporting of Acute Kidney Injury and Tubulointerstitial Nephritis: A FAERS Pharmacovigilance Study, 2020–2025

by Thamir M. Alshammari, Mohammad Kanan Alshammari, Hind M. Alosaimi, Ayesha Yasmeen and Mamoon H. Syed

J. Clin. Med. 2026, 15(3), 1298; https://doi.org/10.3390/jcm15031298 - 6 Feb 2026

Cited by 1 | Viewed by 767

Abstract

Background/Objectives: Proton pump inhibitors (PPIs) are widely used, yet questions persist about kidney-related adverse events. We evaluated disproportional reporting of acute kidney injury (AKI) and tubulointerstitial nephritis (TIN) with PPIs in the FDA Adverse Event Reporting System (FAERS) from 2020 to 2025. Methods: [...] Read more.

Background/Objectives: Proton pump inhibitors (PPIs) are widely used, yet questions persist about kidney-related adverse events. We evaluated disproportional reporting of acute kidney injury (AKI) and tubulointerstitial nephritis (TIN) with PPIs in the FDA Adverse Event Reporting System (FAERS) from 2020 to 2025. Methods: FAERS reports were screened using MedDRA Preferred Terms. Report characteristics and annual counts of AKI and TIN reports were summarized. Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Empirical Bayes Geometric Mean (EBGM), and Information Content (IC) were used to assess disproportionality. Results: We identified 13,654 PPI-associated AKI reports and 2409 TIN reports in FAERS (2020–2025). Reports were predominantly from the United States, and missing age/sex information was common. Hospitalization was reported in 12.3% of AKI and 22.7% of TIN reports, and death in 9.1% and 5.0%, respectively. Across all years, disproportionality analyses using ROR, PRR, EBGM, and IC consistently met signal thresholds for both outcomes, with stronger signals in 2020–2022 and attenuation thereafter alongside declining report counts. Conclusions: FAERS data show persistent disproportional reporting of AKI and TIN with PPI use. Causality cannot be inferred, but the findings support cautious, indication-based PPI prescribing and highlight the need for robust studies to clarify renal safety. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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16 pages, 682 KB

Open AccessArticle

Real-World Safety of Cyproheptadine-Based Appetite Stimulants: An Electronic Health Record-Based Retrospective Cohort Study in Adult Patients

by Minoh Ko, Kwangsoo Kim, Heeman Jang, Soomin Lee, Bumkyu Shin, Belong Cho, Seungyeon Kim and Ha Young Jang

J. Clin. Med. 2026, 15(1), 54; https://doi.org/10.3390/jcm15010054 - 21 Dec 2025

Viewed by 1761

Abstract

Background: Cyproheptadine-based appetite stimulants (CAS) have been safely used in Korea for over 30 years. However, in older adults who are vulnerable to malnutrition, sarcopenia, and fall-related morbidity, safety of CAS in nutrition care remains uncertain due to limited evidence and its [...] Read more.

Background: Cyproheptadine-based appetite stimulants (CAS) have been safely used in Korea for over 30 years. However, in older adults who are vulnerable to malnutrition, sarcopenia, and fall-related morbidity, safety of CAS in nutrition care remains uncertain due to limited evidence and its antihistaminic effects. This study aimed to assess the real-world safety of CAS compared with megestrol and other antihistamines to inform safe pharmacologic support within clinical nutrition practice. Methods: A retrospective observational study was conducted using Seoul National University Hospital’s common data model. Patients who were prescribed CAS, megestrol, or antihistamines between 2004 and 2022 were enrolled. To balance covariates, propensity score matching was applied. The primary outcomes—dizziness, sedation, and hypotension—were evaluated within 30 days of drug administration. Additionally, sensitivity analyses and subgroup assessments by age and duration of use were performed to evaluate robustness of the findings. Results: No significant differences were observed in the risk of dizziness, sedation, or hypotension when CAS was compared to megestrol, with adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) of 1.02 (0.70–1.50) for dizziness, 0.53 (0.19–1.54) for sedation, and 0.70 (0.34–1.44) for hypotension. Similar findings were noted in the comparison with antihistamines, where the aHRs for dizziness, sedation, or hypotension of 0.56 (0.41–0.78), 1.05 (0.46–2.38), and 0.65 (0.36–1.17), respectively. Conclusions: CAS demonstrated an acceptable safety profile in older adults, with safety comparable to both megestrol and antihistamines. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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15 pages, 582 KB

Open AccessFeature PaperArticle

The Role of the Lymphocyte Transformation Test in Immune-Related Adverse Events from Immune Checkpoint Inhibitors: A Case Series

by Fiorela C. Dueñas Lopez, Zoraida del Solar Moreno, Daniela Aguilar-Concepción, Carmen Ruiz-Fernández, Ibtissam Akatbach-Bousaid, Olga Rogozina, Susana Martín-López, Ana Martínez Feito, Miguel González-Muñoz and Elena Ramírez

J. Clin. Med. 2025, 14(23), 8596; https://doi.org/10.3390/jcm14238596 - 4 Dec 2025

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Abstract

Background: Immune-related adverse events (irAEs) represent a considerable complication associated with the use of immune checkpoint inhibitors (ICIs) in oncology patients. Assessing causality is particularly challenging in patients administered multiple therapeutic agents. The Lymphocyte Transformation Test (LTT) may aid in causality analysis, [...] Read more.

Background: Immune-related adverse events (irAEs) represent a considerable complication associated with the use of immune checkpoint inhibitors (ICIs) in oncology patients. Assessing causality is particularly challenging in patients administered multiple therapeutic agents. The Lymphocyte Transformation Test (LTT) may aid in causality analysis, although its clinical utility remains investigational. Objectives: To evaluate the potential utility of the Lymphocyte Transformation Test (LTT) in the causality analysis of irAEs in cancer patients and to assist clinicians in the decision-making process regarding ICI rechallenge. Methodology: We present a case series of seventeen cancer patients who developed irAEs during ICI therapy. Causality was assessed using the Spanish Pharmacovigilance System, and LTT was performed for both ICIs and co-medications. Results: Events primarily affect hepatic, respiratory, and renal functions. Five patients showed a positive LTT to ICIs (range 3.9–13.6), all with high-grade irAEs, and none underwent rechallenge. Six patients were positive for concomitant drugs: three tested positive for both. The initial high-grade irAEs rate was 53.9%. After rechallenging, 81.8% had all-grade and 45.5% had high-grade irAEs, predominantly pneumonitis. Conclusions: LTT may provide supportive evidence in complex irAE cases and assist clinicians in decision-making regarding ICI rechallenge. More prospective studies are needed. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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11 pages, 1174 KB

Open AccessArticle

Comparative Renal Safety of Tirzepatide and Semaglutide: An FDA Adverse Event Reporting System (FAERS)—Disproportionality Study

by Ayush Gandhi, Nilay Bhatt and Alireza Parhizgar

J. Clin. Med. 2025, 14(21), 7678; https://doi.org/10.3390/jcm14217678 - 29 Oct 2025

Viewed by 6289

Abstract

Background: Acute kidney injury (AKI) remains a serious complication among individuals with type 2 diabetes. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely prescribed and often regarded as kidney-protective, yet post-marketing reports have linked them to AKI. Tirzepatide, a newer dual GIP/GLP-1 agonist, [...] Read more.

Background: Acute kidney injury (AKI) remains a serious complication among individuals with type 2 diabetes. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely prescribed and often regarded as kidney-protective, yet post-marketing reports have linked them to AKI. Tirzepatide, a newer dual GIP/GLP-1 agonist, shows well-documented metabolic benefits, but its renal safety in real-world use is not well characterized. Methods: We conducted a disproportionality analysis of the U.S. FDA Adverse Event Reporting System (FAERS) from January 2022 to September 2025. Reporting odds ratios (RORs) and proportional reporting ratios (PRRs) were used to compare AKI reporting between tirzepatide and semaglutide. Results: Among 133,872 reports (92,807 tirzepatide; 41,065 semaglutide), AKI was listed in 432 (0.47%) and 440 (1.07%) cases, respectively. The ROR for tirzepatide versus semaglutide was 0.44 (95% CI, 0.38–0.50), suggesting a lower reporting frequency for AKI with tirzepatide. Conclusions: In this real-world pharmacovigilance analysis, semaglutide but not tirzepatide showed a disproportionality signal for AKI. While causality cannot be confirmed, clinicians should ensure hydration and renal monitoring when initiating GLP-1 RAs, particularly semaglutide. Semaglutide showed a higher AKI reporting rate than tirzepatide, though these findings should be interpreted cautiously given reporting bias and potential confounders. Both agents appear safe, with low AKI frequency in practice. Further studies should determine if differences reflect biological or reporting effects. These findings support the need for larger epidemiologic studies to define risk modifiers and optimize clinical safety strategies. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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23 pages, 1561 KB

Open AccessArticle

Isotretinoin Treatment for Acne Vulgaris: A Five-Year Retrospective Analysis of Clinical and Biochemical Adverse Effects

by Igor Jarosław Feszak, Piotr Brzeziński, Sylwia Feszak, Aleksandra Kitowska, Monika Waśkow, Piotr Kawczak and Tomasz Bączek

J. Clin. Med. 2025, 14(18), 6473; https://doi.org/10.3390/jcm14186473 - 14 Sep 2025

Cited by 3 | Viewed by 16199

Abstract

Objectives: Oral isotretinoin remains the most effective therapy for severe acne, but its exceptional efficacy is often accompanied by relatively frequent adverse effects. In this study, we quantified the frequency- and dose-related predictors of clinical and biochemical adverse effects during isotretinoin treatment in [...] Read more.

Objectives: Oral isotretinoin remains the most effective therapy for severe acne, but its exceptional efficacy is often accompanied by relatively frequent adverse effects. In this study, we quantified the frequency- and dose-related predictors of clinical and biochemical adverse effects during isotretinoin treatment in routine Polish practice. Methods: The records of 370 patients (mean age: 28 ± 12 years) who began isotretinoin treatment between June 2020 and June 2025 were reviewed. The mean daily isotretinoin and cumulative isotretinoin doses were 23.4 ± 9.1 mg and 88.3 ± 31.5 mg/kg, respectively. The adverse events documented at two-monthly visits were correlated with age and dosing. Lipid, hepatic, thyroid and prolactin panels were compared with age- and sex-matched controls using χ² statistics and odds ratios (ORs). Results: Xerosis (70%), retinoid dermatitis (20%) and cheilitis (15.5%) predominated. Hand eczema rose with higher daily isotretinoin doses (ρ = 0.082; p = 0.037), whereas pruritus declined with greater cumulative isotretinoin exposure (ρ = −0.088; p = 0.037). Retinoid dermatitis was linked to a younger age (ρ = −0.080; p = 0.0286), whereas desquamation increased slightly with age (ρ = +0.083 p = 0.0228). Overall, dyslipidemia was twice as common as in the controls (OR: 2.06; 95% CI: 1.49–2.86; p-value: <0.0001), which was driven by an elevated total cholesterol (OR: 1.93; 95% CI: 1.34–2.77; p-value: 0.0004), LDL (OR: 3.40; 95% CI: 2.26–5.10; p-value: <0.0001) and triglycerides (OR: 1.95; 95% CI: 1.20–3.17; p-value: 0.0062) and decreased HDL (OR: 2.68; 95% CI: 1.75–4.10; p-value: <0.0001). Interestingly, hyperprolactinemia occurred eight-fold more often (OR: 8.42; 95%; 95% CI: 2.97–23.84; p-value: <0.00001). Aminotransferase and TSH elevations were infrequent and statistically non-significant. Conclusions: At moderate cumulative doses, isotretinoin was generally well tolerated; however, clinically relevant lipid and prolactin disturbances were frequent. Routine lipid and endocrine monitoring, early emollient prophylaxis and dose individualization are recommended to ensure safe isotretinoin usage in everyday practice. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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11 pages, 204 KB

Open AccessArticle

Post-Marketing Safety of Spinal Muscular Atrophy Therapies: Analysis of Spontaneous Adverse Drug Reactions from EudraVigilance

by Andrej Belančić, Petar Mas, Lara Miletić, Barbara Kovačić Bytyqi and Dinko Vitezić

J. Clin. Med. 2025, 14(9), 3173; https://doi.org/10.3390/jcm14093173 - 3 May 2025

Cited by 2 | Viewed by 1759

Abstract

Background/Objectives: Spinal muscular atrophy (SMA) treatment has evolved with the approval of nusinersen, onasemnogene abeparvovec, and risdiplam. This study aims to assess the post-marketing safety profile of these therapies through the spontaneous adverse drug reaction (ADR) reports available in EudraVigilance (EV). Methods [...] Read more.

Background/Objectives: Spinal muscular atrophy (SMA) treatment has evolved with the approval of nusinersen, onasemnogene abeparvovec, and risdiplam. This study aims to assess the post-marketing safety profile of these therapies through the spontaneous adverse drug reaction (ADR) reports available in EudraVigilance (EV). Methods: Data from EV were retrieved via adrreports.eu for the suspected ADRs associated with nusinersen, onasemnogene abeparvovec, and risdiplam from their approval in the European Economic Area (EEA) to 31 December 2024. The ADR reports were exported and analysed using descriptive statistics in Microsoft Excel. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated for suspected ADRs, focusing on reactions with a lower limit of the 95% CI exceeding 1. Results: A total of 3196, 806, and 956 individual case safety reports (ICSRs) were identified for nusinersen, onasemnogene abeparvovec, and risdiplam, respectively. The most frequently reported ADRs with significantly increased RORs included post-lumbar puncture syndrome (nusinersen: 11%), pyrexia (onasemnogene abeparvovec: 23%), and pneumonia (risdiplam: 9%). While some ADRs were therapy-specific, others were consistent with SMA disease progression and complications. Onasemnogene abeparvovec showed a notable prevalence of hepatotoxicity, while risdiplam was associated with gastrointestinal and respiratory events. Conclusions: To conclude, the analysis reinforces the known safety profiles of these SMA treatments while highlighting potential areas for further investigation. ADRs related to SMA complications require careful differentiation from true drug-related effects. Future pharmacovigilance efforts should focus on long-term safety assessments and real-world evidence to optimize treatment strategies. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

Review

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40 pages, 553 KB

Open AccessReview

Drug-Induced Hyponatremia: Insights into Pharmacological Mechanisms and Clinical Practice Management

by Miguel Capinha, Marta Lavrador, Joana Liberato, Adriana Pinheiro, Ana Aveiro, Isabel Vitória Figueiredo and Margarida Castel-Branco

J. Clin. Med. 2025, 14(18), 6584; https://doi.org/10.3390/jcm14186584 - 18 Sep 2025

Cited by 2 | Viewed by 14106

Abstract

Background: Hyponatremia (serum sodium concentration < 135 mmol/L) represents the most common electrolyte disturbance in clinical practice, particularly among high-risk populations such as older adults. Its severity ranges from moderately severe to life-threatening symptoms, contributing to increased mortality. Its etiology is widely heterogeneous [...] Read more.

Background: Hyponatremia (serum sodium concentration < 135 mmol/L) represents the most common electrolyte disturbance in clinical practice, particularly among high-risk populations such as older adults. Its severity ranges from moderately severe to life-threatening symptoms, contributing to increased mortality. Its etiology is widely heterogeneous and leads to different classifications according to volume status such as hypovolemic, euvolemic and hypervolemic hyponatremia. Drug-induced hyponatremia presents itself as one of the most prevalent but frequently overlooked causes, since many confounding factors like associated comorbidities and polypharmacy complicate the identification of specific medicines as the main offenders. Objectives: This narrative review was performed to provide a comprehensive analysis on drug-induced hyponatremia, focusing not only on the underlying pharmacological mechanisms, but also on management strategies in clinical practice. Methods: A narrative literature review was conducted using PubMed, Science Direct and Google Scholar. Results: This narrative review focused not only on the most common drug classes to induce hyponatremia through different mechanisms, including diuretics, antidepressants, anticonvulsants, and antipsychotics, but also on other pharmacological classes, that, although to a lesser extent, might also be associated with decreasing serum sodium levels (antineoplastic and immunomodulating agents, drugs acting on digestive and locomotor systems, anti-infective drugs, endocrine diseases drugs, among others). It also explores recommendations on the management of drug-induced hyponatremia and it emphasizes the role of healthcare providers in addressing this electrolyte disorder. Conclusions: As drug-induced hyponatremia poses significant challenges in clinical practice, understanding its mechanisms, coupled with effective management strategies, can enhance patient safety. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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25 pages, 1139 KB

Open AccessReview

Lamotrigine Therapy: Relation Between Treatment of Bipolar Affective Disorder and Incidence of Stevens–Johnson Syndrome—A Narrative Review of the Existing Literature

by Kacper Żełabowski, Kacper Wojtysiak, Zuzanna Ratka, Kamil Biedka and Agnieszka Chłopaś-Konowałek

J. Clin. Med. 2025, 14(12), 4103; https://doi.org/10.3390/jcm14124103 - 10 Jun 2025

Cited by 4 | Viewed by 12525

Abstract

Lamotrigine is the drug of choice for the treatment of depressive episodes in bipolar disorder (BD). Despite its generally favorable tolerability profile, lamotrigine use is associated with a risk of Cutaneous Adverse Drug Reactions (cADRs), including Stevens–Johnson Syndrome (SJS) and Lyell’s syndrome, also [...] Read more.

Lamotrigine is the drug of choice for the treatment of depressive episodes in bipolar disorder (BD). Despite its generally favorable tolerability profile, lamotrigine use is associated with a risk of Cutaneous Adverse Drug Reactions (cADRs), including Stevens–Johnson Syndrome (SJS) and Lyell’s syndrome, also known as toxic epidermal necrolysis (TEN). Genetic markers HLA and, in particular, HLA-B 15:02 and HLA-A 31:01 are crucial in predicting individuals’ susceptibility to developing the symptoms. The symptoms are triggered by type IV hypersensitivity developing because of CTL and NK cell activation, leading to keratinocyte apoptosis, epidermal necrosis and skin detachment. The exact pharmacotherapy that should be widely utilized in treating affected patients has not yet been established. New therapies including JAK inhibitors or cyclosporine show potential in improving outcomes by reducing mortality and enhancing the period of recovery. Key factors in preventing cADRs may include adequate patient observation, gradual titration of the patient’s dose, and reduction of risk factors through screening for HLA polymorphisms. When the initial symptoms of cADR are identified, it is imperative to make an immediate decision to discontinue treatment, as this can significantly reduce the risk of progression to SJS/TEN and systemic complications. The purpose of this review is to identify a significant correlation between lamotrigine use in BD and the occurrence of SJS by showing the risk factors, neuropharmacological mechanisms, immune response and correctness of pharmacotherapy. Full article

(This article belongs to the Special Issue Clinical Pharmacology: Adverse Drug Reactions)

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