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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.
Between 1998 and 2007, 33 serious adverse drug or device reactions have been reported by RADAR investigators. The toxicities involved multiple biological system and included thrombotic thrombocytopenic purpura (TTP) (ticlopidine and clopidogrel), thromboembolism (thalidomide and lenalidomide), liver failure (gemtuzumab and nevirapine), hypersensitivity (drug eluting coronary arterial stents ...
Steady state (plateau) levels of the drug are attained after two weeks of administration with a dosage of 150 mg twice daily (300 mg/day total). [82] It is metabolized by CYP2C19, with at least five metabolites. [5] Virtually all of the antiandrogenic activity of nilutamide comes from the parent drug (as opposed to metabolites). [83]
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.
In adverse drug reactions involving overdoses, the toxic effect is simply an extension of the pharmacological effect (Type A adverse drug reactions). On the other hand, clinical symptoms of idiosyncratic drug reactions (Type B adverse drug reactions) are different from the pharmacological effect of the drug.
Guidance should also be provided to the clinical investigator on the recognition and treatment of possible overdose and adverse drug reactions that is based on previous human experience and on the pharmacology of the investigational product". [2] The sponsor is responsible for keeping the information in the IB up-to-date.
One of the most prevalent forms of adverse drug reactions is cutaneous reactions, [1] with drug-induced urticaria ranking as the second most common type, preceded by drug-induced exanthems. [2] Urticaria, commonly known as hives , manifests as weals, itching, burning, redness, swelling, and angioedema —a rapid swelling of lower skin layers ...
The risk of first-degree relatives developing the same hypersensitivity reaction is higher than in the general population. [ 1 ] As this syndrome can present secondary to multiple anticonvulsants, the general term "anticonvulsant hypersensitivity syndrome" (AHS) is favored over the original descriptive term "dilantin hypersensitivity syndrome."