Tragic Consequences Unveiled: Case Series Reveals Deadly Adverse Drug Reactions at Leading North Indian Teaching Hospitals

 

The burden of fatal adverse drug reactions (FADRs) in the medical field is considerable, yet there is a lack of comprehensive epidemiological data from India compared to the Western world. In this study, we present a case series detailing Reporting fatal adverse drug reactions observed over a two-year period in a tertiary care teaching hospital. The point prevalence of FADRs was found to be 0.223%, while the overall point prevalence of all-cause mortality in the hospital stood at 1.20%.

The drugs implicated in causing Reporting fatal adverse drug reactions included injection bupivacaine, amphotericin B, directly observed treatment short-course Category-1, injection streptokinase, and tablet ferrous sulfate. Except for one case labeled as probable, all FADRs were categorized as possible, all falling under type A reactions. Central nervous system involvement was noted in three out of five cases, while hepatic system and multiorgan failure accounted for one case each.

Of the cases, two were classified as acute, two as subacute, and one as latent in nature. The importance of reporting fatal adverse drug reactions cannot be overstated, as it plays a crucial role in ensuring patient safety and preventing future adverse events.

 

Exploring the Grim Reality: Fatal Adverse Drug Reactions in Indian Healthcare

Introduction

Adverse drug reactions (ADRs) stand as a significant contributor to morbidity and mortality worldwide. Shockingly, fatal ADRs (FADRs) afflict approximately 0.32% of hospitalized patients, revealing an alarming toll on human life. While data from the Western world shed light on this issue, there remains a paucity of comprehensive information from India. Understanding and reporting fatal adverse drug reactions are crucial not only for patient safety but also for guiding regulatory interventions to mitigate drug-induced fatalities. Herein, we present a case series documenting FADRs observed over a two-year period.

 

Case Reports

Case 1: A 21-year-old male underwent elective surgery and received injection bupivacaine for spinal anesthesia. However, he swiftly deteriorated into shock and succumbed within a day.

Case 2: A HIV-positive female with candida esophagitis received amphotericin B, leading to seizures and subsequent death after seven days.

Case 3: A hypertensive postmenopausal female on anti-tubercular therapy developed drug-induced hepatitis, progressing to hepatic encephalopathy and eventual demise.

Case 4: A hypothyroid male with myocardial infarction received streptokinase, developing intracerebral hemorrhage and passing away six days later.

Case 5: A toddler ingested iron tablets meant for her mother, resulting in gastrointestinal bleeding, multiorgan failure, and death within two days.

Discussion

The majority of fatal adverse drug reactions in our series were probable, implicating drugs like bupivacaine, amphotericin B, anti-tubercular therapy, streptokinase, and iron sulfate. Central nervous system involvement predominated, highlighting the diverse clinical presentations of FADRs. Notably, our study revealed a FADR prevalence of 0.223%, underscoring the urgency for heightened surveillance and reporting mechanisms.

Conclusion

This case series underscores the imperative for a dedicated national database on FADRs in India. Such initiatives are paramount for bolstering patient safety measures and mitigating the burden of drug-induced fatalities.

FAQs (Frequently Asked Questions)

1. What are adverse drug reactions (ADRs)? Adverse drug reactions refer to harmful or unintended reactions caused by medications, ranging from mild to severe, including fatalities.
2. Why is it important to report fatal adverse drug reactions ? Reporting fatal adverse drug reactions is crucial for identifying potential risks associated with medications, enhancing patient safety, and guiding regulatory interventions to prevent future adverse events.
3. What factors contribute to fatal adverse drug reactions ? fatal adverse drug reactions can stem from various factors, including individual patient characteristics, drug interactions, dosing errors, and underlying medical conditions.
4. How can healthcare professionals mitigate fatal adverse drug reactions? Healthcare professionals can mitigate fatal adverse drug reactions through vigilant monitoring of patients, adherence to prescribing guidelines, comprehensive medication reconciliation, and prompt reporting of suspected adverse events.
5. What role do regulatory authorities play in addressing fatal adverse drug reactions? Regulatory authorities play a pivotal role in monitoring drug safety, evaluating adverse event reports, implementing risk mitigation strategies, and disseminating safety information to healthcare providers and the public.

 

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