Nature and Mechanisms of ADRs in Clinical Research and Pharmacovigilance

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Questions and Answers

What is the mechanism for the adverse drug reaction (ADR) causing prolongation of the QT interval on the electrocardiogram?

  • Exaggerated therapeutic response at target site
  • Desired pharmacological effect at another site
  • Triggering an immunological response
  • Additional (secondary) pharmacological actions (correct)

Which of the following is an example of a unique syndrome caused only by a specific drug?

  • Headache with glyceryltrinitrate
  • Prolongation of the QT interval on the electrocardiogram
  • Bleeding with warfarin
  • Vaginal cancer in young women caused by maternal exposure to diethylstilboestrol (correct)

Which adverse effect is mentioned to be caused by practolol?

  • Eosinophilia‐myalgia syndrome
  • Vaginal cancer in young women
  • Oculomucocutaneous syndrome (correct)
  • Fibrosing colonopathy

What is the adverse effect caused by some l‐tryptophan products?

<p>Eosinophilia‐myalgia syndrome (B)</p> Signup and view all the answers

Which of the following represents triggering an immunological response as a mechanism for adverse drug reactions?

<p>Anaphylaxis due to many drugs (B)</p> Signup and view all the answers

What is the main advantage of selective serotonin re‐uptake inhibitors (SSRIs) over older tricyclic antidepressants?

<p>They are less toxic to the heart in overdose (C)</p> Signup and view all the answers

What controversial issues have been associated with the use of SSRIs?

<p>Withdrawal reactions and increased risk of suicide (C)</p> Signup and view all the answers

Which specific SSRI was identified to have a higher incidence of withdrawal reactions?

<p>Paroxetine (Seroxat) (B)</p> Signup and view all the answers

What is the potential risk associated with depressed patients taking an overdose of older tricyclic antidepressants?

<p>Toxicity to the heart (A)</p> Signup and view all the answers

What contributed to the widespread use of selective serotonin re‐uptake inhibitors (SSRIs) over older tricyclic antidepressants?

<p>They are less toxic to the heart in overdose (D)</p> Signup and view all the answers

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