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Related Concept Videos

Pharmacokinetics: Drug–Food and Drug–Viral Interactions01:26

Pharmacokinetics: Drug–Food and Drug–Viral Interactions

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A drug interaction occurs when the concurrent use of another drug, food, or an external substance alters the pharmacological activity of a drug. This interaction can modify the action of the original drug, affecting its effectiveness and safety.Drug–food interactions are significant as they impact drug absorption, metabolism, and excretion. For example, grapefruit juice is a well-known disruptor of drug metabolism. It inhibits the cytochrome P450 3A4 enzyme, crucial for the metabolism of...
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Protein synthesis is indispensable for viral replication, as viruses lack the cellular machinery required for this process and must hijack the host's translational apparatus. In response, host cells deploy a critical innate immune defense involving interferons, specialized cytokines that play a central role in inhibiting viral propagation.Upon viral detection, infected cells release interferons that bind to receptors on adjacent uninfected cells, activating the JAK-STAT signaling pathway and...
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Influenza01:27

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Influenza is an acute, highly communicable viral disease that affects the respiratory tract and is responsible for seasonal epidemics worldwide. Influenza A is the most prevalent type associated with widespread outbreaks and is subtyped based on two surface glycoproteins: hemagglutinin (H) and neuraminidase (N), as in H1N1. These glycoproteins are essential for viral infectivity, transmission, and immune recognition. Transmission occurs primarily through respiratory droplets and contaminated...
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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Fluorescence-based Neuraminidase Inhibition Assay to Assess the Susceptibility of Influenza Viruses to The Neuraminidase Inhibitor Class of Antivirals
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The Tamiflu fiasco and lessons learnt.

Yogendra Kumar Gupta1, Meenakshi Meenu1, Prafull Mohan1

  • 1Department of Pharmacology, AIIMS, Ansari Nagar, New Delhi, India.

Indian Journal of Pharmacology
|March 31, 2015
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Summary

Oseltamivir (Tamiflu) efficacy and safety are questioned due to serious adverse events, impacting its clinical utility and stockpiling recommendations. This review examines the Tamiflu controversy and suggests future improvements.

Keywords:
Cochrane reviewH1N1Tamifluflu pandemicrochestockpiling

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Area of Science:

  • Pharmacology
  • Public Health
  • Regulatory Science

Background:

  • Oseltamivir (Tamiflu), a neuraminidase inhibitor, approved in 1999, was widely recommended for influenza treatment and prophylaxis.
  • Concerns regarding serious adverse events, particularly neuropsychiatric events, have emerged, questioning its clinical utility.
  • The drug's initial favorable efficacy and safety profile was largely based on industry-funded studies.

Purpose of the Study:

  • To comprehensively re-examine the clinical utility and risk-benefit ratio of oseltamivir (Tamiflu).
  • To scrutinize regulatory decisions and stockpiling recommendations for oseltamivir.
  • To identify lessons learned from the oseltamivir controversy and propose measures to prevent similar situations.

Main Methods:

  • Review of randomized controlled trials, systematic reviews, and meta-analyses on oseltamivir.
  • Analysis of reported serious adverse events and their association with oseltamivir use.
  • Critical evaluation of regulatory body recommendations and stockpiling guidelines.

Main Results:

  • Recent reviews question the risk-benefit ratio of oseltamivir and the regulatory approval process.
  • Doubts have been raised regarding the clinical utility and widespread stockpiling recommendations for oseltamivir.
  • The episode highlights potential biases in industry-funded research and regulatory oversight.

Conclusions:

  • The oseltamivir (Tamiflu) case presents a "costly mistake" with significant implications for drug regulation and public health policy.
  • There is a need for greater transparency and independent scrutiny in drug evaluation and recommendation processes.
  • Lessons learned should inform future strategies to ensure the safe and effective use of antiviral medications.