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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Diagnosing Pulmonary EmbolismDiagnosing pulmonary embolism (PE) involves clinical assessment and advanced imaging tests. The preferred diagnostic tool is the spiral (helical) CT scan or CT angiography (CTA), which uses intravenous contrast media to visualize the pulmonary vasculature and identify emboli.A ventilation-perfusion (V/Q) scan is an alternative for patients unable to receive contrast media. This scan includes both perfusion and ventilation scanning. Perfusion scanning involves...
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Pulmonary embolism (PE) occurs when a thrombus, fat or air embolus, amniotic fluid, or tumor tissue blocks one or more pulmonary arteries. These blockages originate in the venous system or the right side of the heart.EtiologyPE primarily arises from deep vein thrombosis (DVT) and other hypercoagulable states, such as inherited thrombophilias. Additional etiological factors include venous stasis, commonly seen in obesity, and endothelial injury from surgery and trauma. Less common causes include...
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Therapeutic Drug Monitoring: Affecting Factors01:29

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Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
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Pneumonia I: Introduction01:30

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Pneumonia is an acute respiratory infection that targets the lungs, specifically the alveoli. These tiny air sacs, essential for oxygen exchange, become engorged with pus and fluid, severely hindering breathing, decreasing oxygen absorption, and causing significant pain and discomfort during respiration.
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Prostacyclin receptor agonists are a class of therapeutic agents integral to managing pulmonary arterial hypertension (PAH). These drugs operate by mimicking the action of prostaglandin I2, or PGI2, a naturally occurring compound in the body.
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Lessons from Pharmacovigilance: Pulmonary Immune-Related Adverse Events After Immune Checkpoint Inhibitor Therapy.

Stephen W Reese1, Eugene Cone1, Maya Marchese1

  • 1Department of Surgery, Brigham and Women's Hospital, Center for Surgery and Public Health, Harvard Medical School, Boston, MA, USA.

Lung
|February 22, 2021
PubMed
Summary

Novel immune checkpoint inhibitors (ICIs) are linked to severe pulmonary toxicities like pneumonitis and respiratory failure. These immune-related adverse events, including interstitial lung disease, pose a significant mortality risk and may be underappreciated.

Keywords:
Immune checkpoint inhibitorsPleural diseasePneumonitisPulmonary embolismPulmonary pharmacotherapyPulmonary toxicity

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Area of Science:

  • Oncology
  • Immunology
  • Pharmacovigilance

Background:

  • Immune checkpoint inhibitors (ICIs) targeting PD-1/L1 and CTLA-4 represent a significant advancement in cancer therapy.
  • However, their use is associated with immune-related adverse events (irAEs), particularly affecting the lungs.

Purpose of the Study:

  • To characterize the spectrum and prevalence of pulmonary toxicities associated with novel immune checkpoint inhibitors.
  • To evaluate the association between ICI use and specific pulmonary adverse events.

Main Methods:

  • Analysis of adverse event reports from the W.H.O pharmacovigilance database (VigiBase) up to December 31st, 2019.
  • Utilized disproportionality analysis (frequentist and Bayesian) to detect safety signals for pulmonary irAEs.

Main Results:

  • A total of 9202 pulmonary irAEs were reported, including airway, alveolar, interstitial, pleural, vascular, and non-specific events.
  • Common associations found between ICIs and pneumonitis, interstitial lung disease, pulmonary embolism, and respiratory failure.
  • Most irAEs were severe, contributing significantly to mortality.

Conclusions:

  • Immune checkpoint inhibitors are associated with a wide range of inflammatory pulmonary toxicities.
  • The prevalence and spectrum of these pulmonary complications may be underestimated.