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2013-10-04 Adverse effects Alphabetic classification of types of adverse drug effects Type Type of effect Definition Examples A Augmented pharmacologic al effects Adverse effects that are known to occur from the pharmacology of the drug, and are dose related. They are seldom fetal and relatively common Hypoglycemia due to insulin injection Bradycardia due to βadrenoreceptor antagonists B Bizarre effects Adverse effects that occur unpredictably and often have a high morbidity and mortality. They are uncommon Anaphylaxis due to penicillin 2 Alphabetic classification of types of adverse drug effects Type Type of effect Definition C Chronic effects Adverse effects that only occur during prolonged treatment and not with single doses D Delayed effects Adverse effects that occur remote from treatment, either in the children of treated patients, or in patients themselves years after treatment Examples Iatrogenic Cushing’s syndrom with prednisolone Colonic dysfunction due to laxatives Carcinoma of the vagina in the daughters of women who took diethylstilbestrol during pregnancy 3 1 2013-10-04 Alphabetic classification of types of adverse drug effects Type Type of effect Definition E End-oftreatment effects Adverse effects that occur when a drug is stopped, especially when is stopped suddenly (so-colled withdrawal effects Examples Withdrawal seizures when anticonvulsants such as phenobarbital or phenytoin are stopped Adrenocortical insufficiency after glucocorticosteroi ds such as prdnisolone are stopped 4 Human teratogenesis • Teratogenesis is defined as the dysgenesis of fetal organs as evidenced either structurally or functionally (e.g., brain functions). The typical manifestations of teratogenesis are restricted growth or death of the fetus, carcinogensis, and malformations, defined as defects in organ sructure or function. 5 FDA Drug Risk Classification in Pregnancy • Category A Adequate, well-controlled studies in pregnant women have not shown an increased risk of fetal abnormalities to the fetus in any trimester of pregnancy. Folic acid 6 2 2013-10-04 FDA Drug Risk Classification in Pregnancy • Category B • Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and wellcontrolled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester. • Amoxicillin, Insulin 7 FDA Drug Risk Classification in Pregnancy • Category C • Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women. • Drugs should be given only if the potential benefit justifies the potential risk to the fetus. • Fluoxetin, fluconazole 8 FDA Drug Risk Classification in Pregnancy • Category D • There is positive evidence of human fetal risk • Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. • However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective. • Phenytoin, cancer chemotherapy 9 3 2013-10-04 FDA Drug Risk Classification in Pregnancy • Category X • Adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks. • The use of the product is contraindicated in women who are or may become pregnant. • Thalidomide, isotretinoin 10 MedWatch Reporting by Consumers • MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions and problems with medical products, such as drugs and medical devices. 11 4