Current Drug Safety[JOURNAL]
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200 papers
Treatment of Tislelizumab-Induced Toxic Epidermal Necrolysis and Agranulocytosis: A Case Report and Literature Review.
Zhou Y, Xue H, Lu C … +6 more , Zhang Y, Wu Q, Zhang J, Xie S, Xu X, Guo X
Curr Drug Saf · 2025 · PMID 38910480 · Full text
BACKGROUND: Non-small Cell Lung Cancer (NSCLC) makes up about 85% of lung cancer cases, mainly adenocarcinoma and squamous cell carcinoma. Recently, PD-1 inhibitors have become crucial in NSCLC treatment, significantly e...
BACKGROUND: Non-small Cell Lung Cancer (NSCLC) makes up about 85% of lung cancer cases, mainly adenocarcinoma and squamous cell carcinoma. Recently, PD-1 inhibitors have become crucial in NSCLC treatment, significantly enhancing survival for some. However, side effects, like skin reactions and hematotoxicity, limit their use, with drug-induced TEN and immunotherapy-induced agranulocytosis as severe adverse effects. CASE PRESENTATION: Herein, we have reported the case of a 75-year-old male diagnosed with metastatic Lung Squamous cell Carcinoma (LUSC) in the left lung. He received first-line treatment with one cycle of tislelizumab in combination with nab-paclitaxel and carboplatin, after which he developed Toxic Epidermal Necrolysis (TEN) and granulocytopenia. To address these two serious immune-related Adverse Events (irAEs), the patient was administered methylprednisolone in combination with gamma globulin for TEN and dexamethasone in combination with G-CSF for agranulocytosis. Antibiotics were also administered according to the patient's medication regimen. After treatment, the patient recovered and was discharged from the hospital. It was also noted that the lung tumor condition improved. CONCLUSION: Effective management of severe immune-related side effects from tislelizumab, including TEN and agranulocytosis, can be partly achieved through steroids, gamma globulin, GCSF, and antibiotics. This strategy not only alleviates these adverse effects, but also potentially improves tumor conditions, highlighting the crucial role of vigilant monitoring and management in immunotherapy.
Hypertensive Crisis Associated with Serotonin Syndrome Following Linezolid Administration: Report of Two Cases.
Shahbazi F, Shojaei L
Curr Drug Saf · 2025 · PMID 38847376 · Publisher ↗
INTRODUCTION: Serotonin syndrome is a potentially life-threatening condition that can occur as a result of the therapeutic use of serotonergic medications or drug interaction. In this study, we describe two cases of sero...
INTRODUCTION: Serotonin syndrome is a potentially life-threatening condition that can occur as a result of the therapeutic use of serotonergic medications or drug interaction. In this study, we describe two cases of serotonin syndrome-associated hypertensive crisis following linezolid use. CASE PRESENTATION: The first patient was a 52-year-old female who was admitted due to a diabetic foot infection and pneumonia associated with a decreased consciousness level. Serotonin syndrome occurred 24 hours after starting the linezolid use. Resistant hypertension was the main hemodynamic finding. It could not be controlled with amlodipine, valsartan, prazosin, and nitroglycerin infusion. Resistant hypertension and other symptoms of serotonin syndrome were resolved about 48 hours after discontinuation of linezolid use. The second case was a man with a history of kidney transplant, diabetes, and hypertension. He was admitted to the ICU due to severe COVID-19. Broad-spectrum antibiotics [linezolid, cefepime], and remdesivir was initiated. Following intubation, continuous infusion of fentanyl was used for sedation. Within 24 hours after fentanyl and linezolid initiation, severe agitation, eye clonus, hyperreflexia, hypertension [160-186 /90-110 mmHg], and tachycardia [>100/min] were noted. With the possible diagnosis of serotonin syndrome, fentanyl was discontinued, and morphine was initiated. The patient's symptoms improved 48 hours after discontinuation of fentanyl. CONCLUSION: Both patients had a history of well- controlled hypertension. Hypertensive crisis has occurred after recent or concurrent use of serotonergic agents with linezolid. A thorough evaluation of the patient's medical history and current condition can help clinicians prevent this syndrome in critically ill patients.
Drug-induced Tongue Disorders: A Comprehensive Literature Review.
Amiri S, Nikvarz N, Sabouri S
Curr Drug Saf · 2025 · PMID 38797908 · Publisher ↗
INTRODUCTION: Some drugs cause tongue disorders as adverse effects. Most of the drug-induced tongue disorders are benign and will resolve after drug discontinuation. However, the changes in the color or appearance of the...
INTRODUCTION: Some drugs cause tongue disorders as adverse effects. Most of the drug-induced tongue disorders are benign and will resolve after drug discontinuation. However, the changes in the color or appearance of the tongue may frighten patients and decrease compliance with drug therapy. OBJECTIVE: To review the literature to find all reports of drug-induced tongue disorders, their presentation, management, and outcome of patients. METHODS: The search was conducted in Google Scholar and PubMed using key words "ageusia," "burning tongue," "coated tongue," "drug-induced taste disturbances," "dysgeusia," "glossitis," "glossodynia," "hairy tongue," "hypogeusia," "stomatodynia," "stomatopyrosis," "swollen tongue" "tongue discoloration," "tongue irritation," "tongue numbness, "tongue oedema," and "tongue ulcer. All reports that were published from 1980 to 2022 in the English language were included in the study. Reports that were not in English language but had English abstracts with adequate data for extraction were also included. RESULTS: A total of 208 case reports and case series were included. The most reported drug classes were antineoplastic and immunomodulating agents and anti-infectives for systemic use, and the most common tongue disorders were tongue discoloration and black hairy tongue. Having good oral hygiene and discontinuing the offending drug could manage and resolve the problem. CONCLUSION: Drug-induced tongue disorders are not rare adverse drug reactions. They are benign in most cases, and withholding offending agents results in significant improvement or complete resolution of tongue lesions.
Suicidal Thoughts and Self-injurious Behavior Associated With Glucagon- Like Peptide-1 Receptor Agonists - A Review.
Maideen NMP, Al Rashid S
Curr Drug Saf · 2025 · PMID 38766830 · Publisher ↗
GLP-1 receptor agonists mimic the actions of GLP-1 and are used to manage type 2 diabetes and help with weight loss. In recent times, antidiabetic GLP-1 receptor agonists have been misused widely for weight loss. This re...
GLP-1 receptor agonists mimic the actions of GLP-1 and are used to manage type 2 diabetes and help with weight loss. In recent times, antidiabetic GLP-1 receptor agonists have been misused widely for weight loss. This review article focuses on some serious side effects of GLP-1 receptor agonists, notified by different regulatory agencies. We searched the literature in online databases such as Medline/Pubmed/PMC, Google Scholar, Science Direct, Ebsco, Scopus, Web of Science, Embase, and reference lists to identify publications relevant to the serious side effects associated with the use of GLP-1 receptor agonists. Various pharmacovigilance analyses and notifications from different regulatory agencies have documented the occurrence of suicidal thoughts and self-injurious behavior associated with the use of GLP-1 receptor agonists. Healthcare professionals should be aware of GLP-1 receptor agonistsassociated suicidal thoughts and self-injurious behavior. Patients should not misuse/abuse antidiabetic GLP-1 receptor agonists and should consult their physician before using any GLP-1 receptor agonists for weight loss.
Herbal Interactions with Cardiac Medications: A Comprehensive Review of Potential Interactions between Herbal Drugs and Commonly Prescribed Cardiac Medications.
Jyothi MV, Vl AB, Wagh VD … +5 more , Rasheed A, Dayaramani R, Panigrahy UP, Wal P, Gunjal SD
Curr Drug Saf · 2025 · PMID 38726779 · Publisher ↗
BACKGROUND: The concomitant use of herbal remedies in conjunction with conventional cardiac medications has increased significantly in recent years, primarily due to improvements in the quality standards of herbal medici...
BACKGROUND: The concomitant use of herbal remedies in conjunction with conventional cardiac medications has increased significantly in recent years, primarily due to improvements in the quality standards of herbal medicines and the pervasive belief that natural products pose no harm to the human body. Contrary to this belief, multiple phytoconstituents found in herbal products have the potential to interact with conventional cardiac drugs, potentially resulting in severe adverse effects. OBJECTIVE: This review aimed to elucidate the intricacies of these interactions highlighting herbal medications that interact with established pharmaceuticals used for the treatment of cardiovascular disorders. Moreover, the review draws attention to safety concerns and preventative steps that should be taken by patients and medical professionals. This endeavor is vital to avert adverse events stemming from such interactions. METHODS: Our approach entailed a comprehensive literature review employing keywords such as "mechanisms of herb-drug interactions," "herbal medications," and "cardiovascular disorders". The drugs presented in this review were selected based on their popularity among the general population, frequency of their employability, and potential to manifest drug interactions. We sourced pertinent information from reputable databases, including PubMed, Scopus, and Elsevier. RESULTS: Heart or blood vessel disorders are referred to as cardiovascular diseases (CVDs), which include conditions such as heart failure, stroke, hypertensive heart disease, and peripheral arterial disease. The primary underlying factor for the development of CVDs is dyslipidemia, which can be treated with classical antihyperlipidemic drugs such as statins, ezetimibe, and PCSK9-inhibitors. The use of herbal remedies is often unregulated, and there is a lack of scientific evidence supporting their use, particularly in the management of heart failure. Patients may not disclose their use of herbal remedies to health care practitioners, which can result in potential harm. CONCLUSION: Uncontrolled dyslipidemia leads to hypercholesterolemia, which can result in atherosclerotic plaques and blocked arteries and veins. Herbal remedies and botanical products are also used to prevent or treat illnesses, and many prescription pharmaceuticals are made from plant compounds. Herbal remedies are often preferred because of the belief that they are safe and have no potential to cause harm. However, there is insufficient scientific data to support the use of herbal remedies, especially when treating heart disease. Using herbal remedies in conjunction with medicinal pharmaceuticals may result in unfavorable effects.
Suspected Cutaneous Allergic Reactions with Ayurveda Medicine Punaranava Mandura: A Case Report.
Roseleena S, Kholiya P, Chandan N … +3 more , Barvaliya M, Siddapur C, Roy S
Curr Drug Saf · 2025 · PMID 38716496 · Publisher ↗
INTRODUCTION: With the increasing use of traditional medicine, there is a need to be vigilant in identifying and reporting adverse reactions associated with them. Punarnava Mandura is a commonly used Ayurvedic medicine f...
INTRODUCTION: With the increasing use of traditional medicine, there is a need to be vigilant in identifying and reporting adverse reactions associated with them. Punarnava Mandura is a commonly used Ayurvedic medicine for the treatment of anemia. It is well tolerated by the patients. To our knowledge, allergic reactions to Punarnava Mandura have not been reported in the literature. We reported a case of adverse cutaneous reaction, which was probably associated with Purnarnava Mandura. CASE PRESENTATION: A 60-year-old female patient developed skin rashes over her neck region after taking Punarnava Mandura and other drugs for osteoarthritis. She recovered upon withdrawal of all the medicines and treatment with anti-allergic drugs. The patient re-initiated treatment for joint pain except for Punarnava Mandura and completed the course without a recurrence of the event making the Punarnava Mandura the culprit drug. CONCLUSION: Punarnava Mandura may cause allergic reactions, and clinicians should keep such adverse reactions in mind when using traditional medicine and report them to increase the scientific literature in this area.
From Evidence to Practice: A Comprehensive Analysis of Side Effects in Synthetic Anti-Depressant Therapy.
Pannu A, Goyal RK
Curr Drug Saf · 2025 · PMID 38676478 · Publisher ↗
Depression, a pervasive mental health disorder, affects millions worldwide, necessitating the widespread use of synthetic anti-depressant medications. While these pharmaceutical interventions have demonstrated efficacy i...
Depression, a pervasive mental health disorder, affects millions worldwide, necessitating the widespread use of synthetic anti-depressant medications. While these pharmaceutical interventions have demonstrated efficacy in alleviating depressive symptoms, they are not without their associated side effects. This review provides a comprehensive overview of the side effects of synthetic anti-depressants, aiming to enhance the understanding of their clinical implications. Common side effects explored include gastrointestinal disturbances, sexual dysfunction, insomnia, weight gain, and cognitive impairments. Additionally, this review delves into less frequent but potentially severe adverse events, such as serotonin syndrome, hyponatremia, and cardiac complications associated with specific classes of synthetic anti-depressants. Moreover, the review examines the interplay between side effects and treatment adherence, emphasizing the importance of monitoring and managing these effects in clinical practice. It also discusses strategies to mitigate side effects, including dose adjustments, combination therapy, and alternative treatment approaches. In conclusion, this comprehensive review sheds light on the multifaceted landscape of side effects associated with synthetic anti-depressants. By providing clinicians with a nuanced understanding of these effects, it aims to facilitate informed decision-making, personalized treatment plans, and improved patient outcomes in managing depression.
Levetiracetam Induced Behavioural Changes in an Adult Female Patient: A Case Report.
Virani HA, Dabhi HK, Pargi PM
Curr Drug Saf · 2025 · PMID 38584560 · Publisher ↗
BACKGROUND: Levetiracetam, a relatively recent addition to antiepileptic medications, is known for its broad-spectrum efficacy in treating partial and generalized tonic-clonic seizures in individuals of all age groups. D...
BACKGROUND: Levetiracetam, a relatively recent addition to antiepileptic medications, is known for its broad-spectrum efficacy in treating partial and generalized tonic-clonic seizures in individuals of all age groups. Despite its favourable tolerability profile, rare instances of psychiatric side effects have been reported. This case study presents a rare occurrence of significant behavioural changes attributed to levetiracetam in a young female patient. CASE HISTORY: A 40-year-old woman with a long-standing history of epilepsy, well-managed with medication, presented with abrupt-onset behavioural changes, including irritability, aggression, crying spells, insomnia, increased talkativeness, and screaming. Notably, these behavioural changes were unrelated to seizure activity and emerged without precedent. A dose reduction of levetiracetam was also attempted, which proved ineffective in mitigating her symptoms. CONCLUSION: Consequently, the drug was discontinued, resulting in the resolution of the behavioural symptoms. This case highlights levetiracetam as the likely causative factor behind the observed significant behavioural changes.
Dopaminergic Drugs and Valproate-associated Refractory Hyponatremia Over Levosulpiride-induced Parkinsonism in an Elderly Female Patient When Deprescribing was the Only Therapy.
Dehade A, Chakrabarti SS, Reddy NTS … +1 more , Kaur U
Curr Drug Saf · 2025 · PMID 38523545 · Publisher ↗
INTRODUCTION: Prescribing cascade is a condition in which a drug administered to a patient causes an adverse reaction that is misinterpreted as a new condition, resulting in the addition of a new drug. CASE PRESENTATION:...
INTRODUCTION: Prescribing cascade is a condition in which a drug administered to a patient causes an adverse reaction that is misinterpreted as a new condition, resulting in the addition of a new drug. CASE PRESENTATION: Here, we report the case of an elderly female patient who suffered from metabolic, neurologic, and urinary consequences of a prescribing cascade of antiemetic, antiepileptic, and dopaminergic drugs. While levosulpiride caused Parkinsonian symptoms, the dopaminergic drugs and valproate caused refractory hyponatremia followed by altered sensorium, and clidinium contributed to urinary retention. CONCLUSION: The case highlights the need to be vigilant for adverse consequences of the prescribing cascade, especially for antiemetic drugs, such as levosulpiride, because of its propensity to induce extrapyramidal reactions in older patients. In cases of refractory hyponatremia, a trial of de-challenge of valproate and dopaminergic drugs should be considered. The identification and removal of the culprit drugs can rescue the patient from a disabling cycle of adverse drug reactions.
Hand Foot Syndrome Induced by Lenvatinib - A Case Report.
Rangshahi K, Nanda S, Gurunthalingam MP … +3 more , Katiyara V, Thangaraju P, Gaikwad NR
Curr Drug Saf · 2025 · PMID 38486391 · Publisher ↗
INTRODUCTION: Hand-Foot Syndrome (HFS), also known as palmar-plantar erythrodysesthesia, is a common reaction to Tyrosine Kinase Inhibitors (TKIs), which can often lead to discontinuation of the drug. Lenvatinib is a rec...
INTRODUCTION: Hand-Foot Syndrome (HFS), also known as palmar-plantar erythrodysesthesia, is a common reaction to Tyrosine Kinase Inhibitors (TKIs), which can often lead to discontinuation of the drug. Lenvatinib is a recently approved drug for the treatment of endometrial carcinoma, which has been proven to provide a better overall survival rate and longer duration of progression-free survival among patients with advanced endometrial cancer. Herein, we have reported a case of carcinoma endometrium with metastasis who had to discontinue the use of lenvatinib due to the adverse drug reaction. CASE REPORT: A 60-year-old female patient with carcinoma endometrium with metastasis, post radical hysterectomy with bilateral salpingo-oophorectomy with omentectomy, was started on tablet lenvatinib 8 mg once daily orally for 15 days. After 12 days of treatment, the patient noticed painful lesions with reddish-black discoloration over the left forearm and dorsal aspect of the left hand and fingers, and was diagnosed with lenvatinib-induced hand-foot syndrome. Lenvatinib was discontinued and tab. prednisolone 30mg was taken orally. The reaction subsided after five days. CONCLUSION: Hand-foot syndrome is one of the commonest ADRs due to the use of lenvatinib. Lenvatinib is an oral formulation that patients can take at their homes. Hence, educating patients regarding the HFS is important so that they report it to the treating physicians on time. It is also essential to educate patients regarding the precautions to be taken to avoid hand-foot syndrome. This will help the physicians with the early discontinuation and appropriate treatment with corticosteroids, which will help in improving the quality of life of the patients already suffering from cancer.
Assessment of Monitoring and Management Practices of Antipsychotic-Induced Hyperprolactinemia at a Medical City in Riyadh, Saudi Arabia: A Retrospective Cohort Study.
Alshabeeb ZH, Alsuwayni B, Alshargi O … +1 more , Abdelazeem AH
Curr Drug Saf · 2025 · PMID 38485677 · Publisher ↗
BACKGROUND: Hyperprolactinemia is a commonly underestimated adverse effect of antipsychotic medications. There are still no consensus guidelines for the optimal monitoring and treatment strategies. OBJECTIVE: The aim of...
BACKGROUND: Hyperprolactinemia is a commonly underestimated adverse effect of antipsychotic medications. There are still no consensus guidelines for the optimal monitoring and treatment strategies. OBJECTIVE: The aim of the study was to assess the monitoring and treatment practices of antipsychotic- induced hyperprolactinemia, in addition to the prevalence and risk factors associated with it. METHODS: A retrospective cohort observational study was conducted among patients attending the psychiatric clinics at an academic tertiary hospital in Riyadh, Saudi Arabia, from May 2020 until May 2021, by reviewing each patient's medical record for up to five years. RESULTS: Among the 662 patients, 35 patients (5.3%) and 242 patients (36.6%) had their serum prolactin levels monitored (at baseline and at follow-up, respectively). The prevalence of hyperprolactinemia was observed in 212 patients (32%). Only 76 patients (36%) were symptomatic. Female gender, younger age, and bipolar disorder had a significantly higher risk of developing hyperprolactinemia. 60% of the confirmed cases received treatment, of which 76 (60%) were adherent to treatment guidelines. The most common treatment strategies implemented were dose reduction (42.5%) and aripiprazole augmentation (29.1%). CONCLUSION: It is imperative to conduct a baseline check of prolactin levels before commencing any antipsychotic therapy. Similarly, routine prolactin level monitoring is recommended regardless of symptoms in patients treated with antipsychotics with a possible prolactin-raising effect. Adherence to evidence-based treatment guidelines can improve patient quality of life and therapeutic compliance.
Xylazine: An Abused Tranq Dope and its Safety Concern.
Ashique S
Curr Drug Saf · 2025 · PMID 38468528 · Publisher ↗
drug called Xylazine has gained notoriety in recent times, earning the nickname "zombie drug" due to reported alarming effects on its users. Although Xylazine is primarily intended for veterinary use as a sedative and mu...
drug called Xylazine has gained notoriety in recent times, earning the nickname "zombie drug" due to reported alarming effects on its users. Although Xylazine is primarily intended for veterinary use as a sedative and muscle relaxant for animals, there have been growing concerns about its misuse among humans, particularly in the context of illicit drug use. However, it is essential to rely on accurate and evidence-based information when discussing the health risks associated with any substance, rather than resorting to sensationalized terms like "zombie drug." The situation involving Xylazine misuse is a matter of concern, and the United States Drug Enforcement Administration has highlighted it as a significant threat to public health.
Perils and Problems in Bispecific T-Cell Engager Antibodies.
Khushboo B, Kumar JR
Curr Drug Saf · 2025 · PMID 38424423 · Publisher ↗
Bispecific antibodies (BsAbs) are promising immunotherapies for cancer treatment designed to engage both tumour and immune cells. However, their use is associated with potential toxicities, including cytokine release syn...
Bispecific antibodies (BsAbs) are promising immunotherapies for cancer treatment designed to engage both tumour and immune cells. However, their use is associated with potential toxicities, including cytokine release syndrome (CRS), neurotoxicity, and on-target, off-tumour toxicity. CRS, characterized by cytokine release, is the most common, potentially life-threatening toxicity. Neurotoxicity presents as neurological symptoms and on-target, off-tumour toxicity damages healthy cells. Incidence and severity vary based on BsAb type, dose, patient factors, and tumor characteristics. For this study, articles pertaining to BsAb toxicity were searched on PubMed. Moreover, the management involves early recognition, dose modification, supportive care, and, in severe cases, immunosuppressive therapy or treatment discontinuation. Clinicians must carefully assess risks and benefits, considering individual patient profiles. Close monitoring and multidisciplinary collaboration are crucial for effective BsAb therapy. All in all, while toxicity is a concern, with vigilant management, BsAbs remain a valuable cancer treatment option.
Evaluation of Appropriate Use of Proton Pump Inhibitors in Non-critically Ill Patients in Tertiary Medical Center: A Retrospective Study.
Althagafi A, Magbool N, Altayib H … +4 more , Bukhari T, Melibari N, Bahamdain F, Eljaaly K
Curr Drug Saf · 2025 · PMID 38347790 · Publisher ↗
BACKGROUND: There are concerns about indiscriminate prescriptions and the inappropriate use of proton pump inhibitors (PPIs) without any clear indications, especially among noncritically hospitalized patients. OBJECTIVE:...
BACKGROUND: There are concerns about indiscriminate prescriptions and the inappropriate use of proton pump inhibitors (PPIs) without any clear indications, especially among noncritically hospitalized patients. OBJECTIVE: This study aimed to characterize PPI prescriptions among non-critically hospitalized patients in a tertiary care hospital in Saudi Arabia. METHODS: A retrospective cross-sectional study was conducted at the King Abdulaziz University Hospital between June and August 2021. The data of adult patients who received PPIs on hospital admission in the medical and surgical wards were collected and analyzed for appropriateness based on the current international guidelines and recommendations. RESULTS: A total of 174 patient records were included in this study. The proportion of patients with appropriate and inappropriate PPI prescriptions was 67.24% (n=117) and 32.76% (n=57), respectively. Female patients (risk=50.00%, 95% CI: 36.89-63.11, p<0.001) were more likely to receive an inappropriate PPI prescription than their male counterparts (risk=33.33%, 95% CI: 24.56-43.43, p<0.001). Intravenous omeprazole 40 mg once daily was the most frequently prescribed PPI (n=62). The hospital length of stay differed significantly between the groups of patients who received appropriate and inappropriate PPIs (24.56 ± 47.14 vs. 13.50 ± 13.84; t=2.34, 95% CI: 1.72-20.4; p=0.02). However, there was no significant difference in the total therapy duration in both the groups (3.76 ± 2.50 vs. 4.75 ± 3.32, t=-1.62, 95%CI: -1.79-0.17; p=0.11). CONCLUSION: The findings show a high trend of inappropriate PPI prescriptions. Hence, educational programs are recommended to encourage healthcare professionals to stick to the approved guidelines when prescribing PPIs.
Role and Responsibilities of Various Stakeholders in Pharmacovigilance.
Phougat P, Beniwal M, Kapoor G … +6 more , Aggarwal N, Kumari A, Sharma R, Chopra H, Sharma R, Kamal MA
Curr Drug Saf · 2025 · PMID 38318830 · Publisher ↗
UNLABELLED: In this review paper, we have analyzed the potential and issues associated with Pharmacovigilance (PV). The analysis is divided into four sections: background, stakeholders, data sources, and medicinal chemis...
UNLABELLED: In this review paper, we have analyzed the potential and issues associated with Pharmacovigilance (PV). The analysis is divided into four sections: background, stakeholders, data sources, and medicinal chemistry. Each section discusses the current state, the future trends, and the best practices of PV. The main purpose, methods, results, and implications of our analysis are summarized. BACKGROUND: PV is the science and practice of monitoring, evaluating, understanding, and preventing adverse drug reactions. PV was established by the World Health Organization in response to the thalidomide tragedy of 1961. The main purpose of PV is to ensure the safety and efficacy of drugs in clinical practice. Stakeholders: PV involves various stakeholders, such as patients, pharmacists, pharmaceutical companies, healthcare professionals, and regulatory authorities. Each stakeholder has a different role and responsibility in reporting, processing, analyzing, and communicating information about adverse drug reactions. Patient engagement is a key factor for enhancing PV practices. DATA SOURCES: PV relies on data from various sources, such as clinical trials, spontaneous reports, electronic medical records, biomedical literature, and patient-reported data in online health forums. These data sources can provide valuable insights into the real-world use and safety of drugs, as well as the preferences and needs of patients. However, these data sources also pose challenges in terms of quality, validity, reliability, and accessibility. Medicinal Chemistry: Medicinal chemistry is the branch of chemistry that deals with the design, synthesis, and evaluation of new drugs and their biological effects. Medicinal chemistry can enhance PV practices by finding new therapeutic indications for existing drugs or compounds that have already been tested for safety and efficacy. Medicinal chemistry also requires careful design and evaluation of covalent inhibitors, bi-substrate inhibitors, stabilizers of protein non-effective conformations, and hydrophobic pocket modifiers to ensure their safety and efficacy. IMPLICATIONS: PV is a dynamic and evolving discipline that requires collaboration, regulation, education, and innovation to improve patient safety and care. This review aims to provide a comprehensive overview of the potential and issues associated with PV practices.
Assessment of Neurologic Safety Profile of Immune Checkpoint Inhibitors: Evaluation of Adverse Drug Reaction Reports.
Khurana A, Dubey H, Arora MK
Curr Drug Saf · 2024 · PMID 38310553 · Publisher ↗
BACKGROUND: Immune checkpoint inhibitors (ICIs) used in immunotherapy have revolutionized cancer management. However, ICI therapy can come with serious neurologic risks. OBJECTIVE: The objective of our study is to analyz...
BACKGROUND: Immune checkpoint inhibitors (ICIs) used in immunotherapy have revolutionized cancer management. However, ICI therapy can come with serious neurologic risks. OBJECTIVE: The objective of our study is to analyze the occurrence of neurologic events with ICIs. METHODS: We referred to EudraVigilance (EV) and VigiAccess to evaluate the frequency of individual case safety reports (ICSRs), including neurologic events with ICIs. Data was gathered for a period from the date of ICI's marketing authorization till 30 January 2023. The computational assessment was conducted with the help of reporting odds ratio (ROR) and its 95% confidence interval (CI). RESULTS: Overall, 8181 ICSRs in EV and 15905 ICSRs from VigiAccess were retrieved for neurologic events, with at least one ICI as the suspected drug. The majority of the ICSRs were reported for nivolumab, pembrolizumab, and ipilimumab, whereas frequently reported events were neuropathy peripheral, myasthenia gravis, seizure, Guillain-Barre syndrome, paraesthesia, syncope, encephalopathy, somnolence. Under EV, 92% of ICSRs were reported as serious, 10% included fatal outcomes, and nearly 61% cited patient recovery. Atezolizumab (ROR 1.64, 95% CI 1.75- 1.52), cemiplimab (ROR 1.61, 95% CI 1.98-1.3), and nivolumab (ROR 1.38, 95% CI 1.44-1.31) had a considerable increase in the frequency of ICSR reporting. Cerebrovascular accident, posterior reversible encephalopathy syndrome, tremor, and somnolence were identified as potential signals. CONCLUSION: ICIs were significantly associated with neurologic risks, which cannot be generalized. A considerable increase in ICSR reporting frequency was observed with atezolizumab, cemiplimab, and nivolumab, while avelumab, pembrolizumab, durvalumab, and cemiplimab were linked with four potential signals. These findings suggest the consideration of a revision of the neurologic safety profile of ICIs. Furthermore, the necessity for additional ad-hoc research is emphasized.
Persistent Hiccups Shortly after Tramadol Intake: A Case Report and Literature Review.
Ali HT, Mohamed ZE, Shalaby MM … +2 more , Caprara ALF, Rissardo JP
Curr Drug Saf · 2025 · PMID 38299410 · Publisher ↗
BACKGROUND AND OBJECTIVE: Tramadol can inhibit serotonin and norepinephrine reuptake leading to stimulation of the central component of the hiccup reflex arc. We have found only two previous cases of tramadol-induced hic...
BACKGROUND AND OBJECTIVE: Tramadol can inhibit serotonin and norepinephrine reuptake leading to stimulation of the central component of the hiccup reflex arc. We have found only two previous cases of tramadol-induced hiccups. Additionally, three pharmacovigilance studies have investigated the involvement of tramadol in cases who have developed hiccups as adverse effects. Herein, we have presented a case of a middle-aged male who has developed hiccups shortly after tramadol intake. CASE PRESENTATION: A 35-year-old male complaining of chronic pain in the right knee was treated with tramadol. The individual developed hiccups within 10 hours of the first tramadol dose. The patient tried to stop the hiccups with non-pharmacological measures, such as stopping the air inside the lungs and drinking cold fluids. The patient appeared to concentrate on avoiding hiccups, which he could avoid for some time. However, then, the hiccups would come all at a unique time. The hiccups occurred at a frequency of one hiccup/5-10 seconds, interrupting the patient's nutrition and sleep pattern. Eventually, tramadol was suspected of inducing hiccups, and baclofen was started. CONCLUSION: Tramadol as well as opioids should be considered as a cause of hiccups. We aim to improve awareness about the safety of such drugs among physicians and the proper management of associated risks.
Impact of Clinical Pharmacist-conducted Medication Reconciliation at Admission and Discharge on Medication Safety in Patients Hospitalized with Acute Decompensated Heart Failure.
Rangchian M, Makhdoumi M, Zamanirafe M … +4 more , Parvaneh E, Eshraghi A, Entezari-Maleki T, Mehrpooya M
Curr Drug Saf · 2025 · PMID 38299281 · Publisher ↗
BACKGROUND: Most studies have focused on the impact of medication reconciliation on one of the points of hospital admission or discharge. In this study, we aimed to investigate the impact of medication reconciliation on...
BACKGROUND: Most studies have focused on the impact of medication reconciliation on one of the points of hospital admission or discharge. In this study, we aimed to investigate the impact of medication reconciliation on medication safety in patients hospitalized with acute decompensated heart failure at both admission and discharge. METHODS: This was a prospective, single-center, cohort study conducted in a tertiary care cardiovascular hospital from December 2022 to May 2023 on patients hospitalized with acute decompensated heart failure. Patients were considered eligible if they were taking at least five chronic medications prior to hospital admission. Medication reconciliation was carried out for the study patients by a clinical pharmacy team both at admission and discharge. Additionally, the study patients also received comprehensive discharge counseling as well as post-discharge follow-up and monitoring. RESULTS: Medication reconciliation was applied for 129 patients at admission and 118 at discharge. The mean time needed for medication reconciliation presses was 32 min per patient at admission and 22 min at discharge. Unintentional medication discrepancies were relatively common at both admission and discharge, but compared to admission, discrepancies were less frequent at discharge (178 versus 72). Based on the consensus review, about 30% of identified errors detected at both admission and discharge were judged to have the potential to cause moderate to severe harm to the patient. Most of the clinical pharmacists' recommendations on unintended discrepancies were accepted by physicians and resulted in changes in medication orders (more than 80%). Further, the majority of the participants were 'very satisfied' or 'satisfied' with the clinical pharmacy services provided to them during hospitalization and after hospital discharge (89.90%). CONCLUSION: Our results demonstrated the vulnerability of heart failure patients to medication discrepancies at both admission and discharge. Thus, implementing a comprehensive medication reconciliation by clinical pharmacists could be beneficial for enhancing medication safety in these patients.
A Systematic Review of the COVID Vaccine's Impact on the Nervous System.
Yella VT, Pareek S, Meena B … +3 more , Sasanka KSBSK, Thangaraju P, T Y SS
Curr Drug Saf · 2025 · PMID 38275049 · Publisher ↗
AIMS & OBJECTIVES: The objective of this study was to conduct a systematic review of research pertaining to the COVID-19 vaccine and its association with neurological complications. METHOD: We performed a comprehensive s...
AIMS & OBJECTIVES: The objective of this study was to conduct a systematic review of research pertaining to the COVID-19 vaccine and its association with neurological complications. METHOD: We performed a comprehensive search of the literature using Google Scholar, PubMed, and NCBI databases from December 2021 to December 2022. For Google Scholar, PubMed, and NCBI databases we used the following key search terms: "neurological adverse effects", "COVID-19 vaccination", "SARS-CoV-2", CNS complications, and CNS adverse effects. Two reviewer authors individually searched and assessed the titles and abstracts of all articles. The third reviewer resolved the disagreement between them. Data were documented regarding title, study location, type of study, type of COVID-19 vaccine, type of neurological complications/ adverse effects, and sample size. RESULTS: From our findings, it is confirmed that these neurological complications like Guillain- Barre syndrome (23.6%), Neuromyelitis Optica spectrum disorder (5.5%), Neuropathy (6.9%), Transverse Myelitis (8.3%) and Acute disseminated Encephalomyelitis (4.1%) are majorly affected in most of the people. The increase in risks associated with SARS-CoV-2 infection far outweighs any previously reported associations with vaccination. CONCLUSION: We found no safety signal was observed between COVID-19 vaccines and the immune- mediated neurological events. Before assuming a causal relationship, the side effects of the COVID-19 vaccine should first be carefully examined to rule out known associated factors. Symptom onset was within two weeks of vaccination in the majority of cases; as such, this seems to be a high-risk period warranting vigilance.
A Severe Case of Isotretinoin Induced Eosinophilic Pneumonia and Pericardial Effusion, a Case Report.
Kampman A, Keulers L, der Maten JV … +2 more , der Meij JV, Bethlehem C
Curr Drug Saf · 2025 · PMID 38275048 · Publisher ↗
BACKGROUND: We report a case of a 25-year-old female who presented with fever, rash and general malaise. CASE PRESENTATION: She was initially diagnosed and treated for peri-/myocarditis, but she deteriorated quickly with...
BACKGROUND: We report a case of a 25-year-old female who presented with fever, rash and general malaise. CASE PRESENTATION: She was initially diagnosed and treated for peri-/myocarditis, but she deteriorated quickly with the development of extensive bilateral consolidations for which she was mechanically ventilated. Two weeks before admission, she took isotretinoin for less than a week for disfiguring acne. Diagnosis of drug-induced acute eosinophilic pneumoniae (EP) was made after excluding other causes of AEP. Even before starting steroid treatment, the patient improved significantly, which was in alignment with the elimination of the active metabolite of isotretinoin. CONCLUSION: The presented case underlines the importance of performing a thorough history and consider recently started drugs as the cause of eosinophilic pneumoniae, even if they have not yet been described as a known trigger of drug-induced EP.
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