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Type A: augmented pharmacological effects, which are dose-dependent and predictable [5]; Type A reactions, which constitute approximately 80% of adverse drug reactions, are usually a consequence of the drug's primary pharmacological effect (e.g., bleeding when using the anticoagulant warfarin) or a low therapeutic index of the drug (e.g., nausea from digoxin), and they are therefore predictable.
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A risk management plan is a documented plan that describes the risks (adverse drug reactions and potential adverse reactions) associated with the use of a drug and how they are being handled (warning on drug label or on packet inserts of possible side effects which if observed should cause the patient to inform/see his physician and/or ...
Peter Breggin asserted that there was an association between fluoxetine (Prozac) use and suicidal thoughts.While his research group were investigating the effectiveness and side effects of the medication, Breggin noticed that only certain individuals responded to the medication with increased thoughts of suicide, and used the challenge–dechallenge–rechallenge protocol in an effort to ...
The types of adverse reactions that should be reported are: Those that have caused death or a serious illness; Any adverse reaction, however minor, if associated with a new medicine or one that is under continued monitoring (highlighted in the British National Formulary with a black triangle)
Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. [7] The FDA also conducts active surveillance of certain regulated products.
The Naranjo algorithm, Naranjo Scale, or Naranjo Nomogram is a questionnaire designed by Naranjo et al. for determining the likelihood of whether an adverse drug reaction (ADR) is actually due to the drug rather than the result of other factors. Probability is assigned via a score termed definite, probable, possible or doubtful.