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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?

Eosinophilia‐myalgia syndrome Signup and view all the answers

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

Anaphylaxis due to many drugs Signup and view all the answers

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

They are less toxic to the heart in overdose Signup and view all the answers

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

Withdrawal reactions and increased risk of suicide Signup and view all the answers

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

Paroxetine (Seroxat) Signup and view all the answers

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

Toxicity to the heart Signup and view all the answers

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