Journal of Pharmacovigilance and Drug Research

Aspirin-induced hemoptysis in a tertiary care centre – A case report

Vishwas G E — 2025-09-01

Introduction: Aspirin, a commonly prescribed antiplatelet agent, is integral in the secondary prevention of cardiovascular diseases. However, its use is associated with various adverse effects, primarily bleeding complications. Hemoptysis, or the expectoration of blood from the lower respiratory tract, is a rare but potentially life-threatening side effect of aspirin therapy.

Case Details: We report the case of a 42-year-old male with a history of dilated cardiomyopathy and chronic alcohol use, who presented with hemoptysis after being on a daily dose of 75 mg aspirin (Ecosprin) for ischemic heart disease prophylaxis. Upon presentation, the patient’s vital signs were stable. Aspirin was promptly discontinued, and treatment included intravenous tranexamic acid and vitamin K. Comprehensive investigations, including blood tests, chest X-ray, and coagulation profile, were conducted. Elevated potassium levels, attributed to concurrent spironolactone use, were noted, and spironolactone was discontinued. The patient responded well to treatment and was subsequently discharged. The adverse event was classified as "Possible" based on the Naranjo ADR assessment scale.

Conclusion: This case underscores the importance of recognizing hemoptysis as a rare adverse effect of aspirin, especially in patients with additional risk factors. Prompt discontinuation of aspirin and appropriate supportive care are essential for managing such cases. Increased awareness and documentation of such adverse reactions are vital for improving patient safety.

Unraveling the Effects – Mifepristone and Misoprostol Linked Congenital Anomalies

Chaithra J. — 2025-09-01

Background: Mifepristone and misoprostol are commonly used in medical abortion, known for their high efficacy. However, their potential association with congenital anomalies, particularly VACTERL anomaly, remains underexplored. This report presents a case of suspected adverse drug reaction leading to VACTERL anomaly.

Case Presentation: A 19-year-old primigravida at 36 weeks gestation presented with lower back and abdominal pain. She had a history of consuming abortion pills after confirming her pregnancy. She delivered a female infant with respiratory distress, diagnosed with multiple congenital anomalies including tracheoesophageal fistula, anal malformation, dextrocardia, and vertebral anomalies, consistent with VACTERL syndrome.

Discussion: This case discusses potential teratogenic effects, disruption of embryonic development, and possible genetic susceptibility as mechanisms for the observed anomalies. Although direct evidence is limited, this case highlights the need for further research and cautious use of these medications.

Conclusion: The case underscores the importance of informed clinical practice and vigilance in recognizing rare adverse drug reactions. Further studies are needed to establish a clear link between these medications and congenital anomalies.

Hepatic Toxicity Induced by Sunitinib Malate: A Rare Case Report

Bhagath R — 2025-09-01

Introduction: Sunitinib malate, an oral multi-targeted tyrosine kinase inhibitor (TKI), is prescribed for metastatic renal cell carcinoma (mRCC) and gastrointestinal stromal tumors (GIST) following imatinib failure. While effective, Sunitinib is associated with various adverse effects, including rare but severe hepatic toxicity. This report discusses a case of acute liver injury attributed to Sunitinib, emphasizing the importance of monitoring liver function in patients undergoing this treatment.

Case Report: A 49-year-old male with GIST on Sunitinib therapy presented with progressive breathlessness, edema, and jaundice over several weeks. Despite normal vital signs, physical examination revealed pallor, jaundice, and pitting edema. Laboratory tests indicated liver dysfunction, and after excluding other causes, Sunitinib-induced acute liver injury was diagnosed. The patient received supportive care, including blood transfusions, and was subsequently discharged.

Conclusion: This case highlights the rare yet significant risk of acute liver injury associated with Sunitinib. Clinicians should monitor liver function vigilantly during Sunitinib therapy. Further research is required to elucidate the mechanisms of Sunitinib-induced hepatotoxicity and to enhance patient safety.

Choreoathetoid Movements in a Type 2 Diabetic Patient Following Initiation of Oral Hypoglycemics: A Case Study

Tanya Vijay Jadhav — 2025-09-01

Introduction: Choreoathetoid movements, characterized by a combination of rapid, jerky, and sustained muscle contractions, can be associated with various neurological conditions and medication side effects. This case report describes a 68-year-old male with newly diagnosed type 2 diabetes mellitus who developed bilateral choreoathetoid movements following the initiation of oral hypoglycemic therapy.

Case Presentation: A 68-year-old male presented with involuntary movements in all limbs after starting treatment with Vildagliptin and Metformin. Neurological evaluation revealed bilateral choreoathetoid movements and oral dyskinesia. Imaging studies showed infarcts in the right basal ganglia.

Discussion: This case highlights the need to consider adverse drug reactions and diabetes-related complications when assessing new-onset choreoathetoid movements. The role of Vildagliptin and Metformin in this presentation remains inconclusive, necessitating further investigation.

Conclusion: The patient’s choreoathetoid movements could be attributed to medication side effects, diabetes complications, or both. Careful evaluation is essential for accurate diagnosis and management.

Pantoprazole-Induced Acute Interstitial Nephritis: A Case Report

Srigouri Rajshekhar Uppin — 2025-09-01

Introduction: Proton pump inhibitors (PPIs), such as pantoprazole, are widely prescribed for managing acid-related gastrointestinal disorders due to their efficacy and safety. However, despite their generally favorable profile, PPIs have been associated with rare but serious adverse effects, including Acute Interstitial Nephritis (AIN). AIN is an immune-mediated condition that can lead to significant renal dysfunction if not promptly recognized and treated.

Case Details: We present the case of a 73-year-old male with a history of ischemic heart disease, who developed AIN following a brief course of intravenous and oral pantoprazole. The patient presented with shortness of breath, bilateral leg swelling, and worsening renal function. Laboratory investigations revealed a marked increase in serum creatinine, and urine analysis showed proteinuria and hematuria. Abdominal ultrasound indicated bilateral grade 1 renal parenchymal disease. Following the cessation of pantoprazole and the initiation of corticosteroid therapy, the patient’s renal function improved, confirming the diagnosis of pantoprazole-induced AIN.

Conclusion: This case highlights the need for heightened clinical awareness of PPI-induced AIN, particularly in elderly patients with recent PPI use. Although rare, this adverse drug reaction can lead to significant renal impairment if not promptly recognized and managed. Clinicians should consider AIN in the differential diagnosis of acute kidney injury in patients on PPIs to prevent irreversible damage.

A Case Report on Tolperisone Induced Anaphylactic Reaction

Akshata G Pounarkar — 2025-09-01

Introduction: Tolperisone is a centrally acting muscle relaxant commonly used to treat muscle spasticity and pain associated with neurological and orthopedic conditions. While generally well tolerated, rare hypersensitivity reactions, including anaphylaxis, have been documented.

Case Presentation: This case report presents a 54-year-old female with a medical history of hypertension and type 2 diabetes mellitus, who developed generalized weakness, malaise and difficulty performing daily tasks within an hour of taking tolperisone. The patient had experienced a similar episode three weeks prior but did not seek medical attention. After taking another dose of tolperisone, the patient experienced worsening symptoms, including weakness following multiple episodes of loose stools, leading to hospitalization. Laboratory investigations revealed elevated white blood cell count and high blood glucose levels. the diagnosis of anaphylaxis secondary to tolperisone was confirmed, and the patient was treated accordingly. Although tolperisone is known to cause mild side effects like dizziness, fatigue, and gastrointestinal disturbances, severe allergic reactions such as anaphylaxis are rare.

Conclusion: A few cases have been reported in the literature, emphasizing the need for caution in patients with a history of allergies. This case underscores the importance of recognizing and managing hypersensitivity reactions promptly to prevent serious complications and ensure positive patient outcomes.

Erythropoietin Induced Atypical Erythema Multiforme in a patient with chronic kidney disease- a rare presentation

Madhurima Roy — 2025-09-01

Introduction: Erythema multiforme is a hypersensitivity reaction to different antigenic stimuli, mostly due to infections followed by drugs. Erythropoietin Induced Erythema Multiforme is one of the rarest serious adverse effects seen till date.

Case Presentation: The patient was a case of Anaemia in Chronic Kidney disease and was advised Inj Erythropoietin 4000 IU, subcutaneously after every 15 days. After taking 2^nd dose of Inj Erythropoietin, the patient developed erythematous polymorphous eruptions over palms, hands, abdomen. Following which the patient developed fever and athralgia. A diagnosis of Erythropoietin Induced Erythema Multiforme was made. Patient recovered completely over few weeks. The adverse event was reported to the regional Pharmacovigilance Centre.

Management: Erythropoesis Stimulating Agents (ESA) are used to treat anaemia in Chronic Kidney Disease. Drug Induced Erythema Multiforme is a delayed Type IV hypersensitivity reaction, associated with prodromal symptoms such as Fever, cough, difficulty in breathing, joint pain and swelling. Patient improves with IV corticosteroids, antihistamines and emollients.

Conclusion: Erythropoietin should be offered meticulously in patients with anaemia in CKD, considering its benefit in terms of quality of life and physical function. Extreme caution to be taken while prescribing Erythropoietin therapy in patients with history of stroke, or any hypersensitivity reaction.