Expert opinion on drug safety
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Expert Opin Drug Saf · Mar 2009
ReviewDrug safety profile of darbepoetin alfa for anemia of chronic kidney disease.
Anemia of chronic kidney disease due to deficiency of erythropoietin is common and has clinical consequences. Erythropoiesis stimulating agents including darbepoetin alfa (DA) are effective in correcting anemia. DA is generally well tolerated and has side effect profile similar to recombinant human erythropoietin. ⋯ DA has been tested extensively in preclinical and clinical studies and significant experience has accumulated in clinical practice. Global safety profile of DA must consider recent data indicating worse survival, poor cardiovascular outcomes and thrombotic risks of targeting near normal hemoglobin levels and administering high doses of erythropoiesis stimulating agents. Strategies to achieve and maintain a reasonable, individualized target hemoglobin level with minimal variations in hemoglobin level are needed.
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Aprotinin is a polypeptide serine protease inhibitor used to prevent bleeding and need for transfusions in patients having heart surgery. A recent analysis of an observational study data set suggested the use of aprotinin was associated with an increased risk of developing renal failure. ⋯ Nonetheless, the evidence points to aprotinin use being associated with a transient small rise in plasma creatinine concentration in certain patients. There is no evidence for an increased risk of developing new renal failure requiring dialysis/renal replacement therapy.
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Clozapine was the first atypical 'broad spectrum' antipsychotic drug to be marketed and the first agent approved for the treatment of schizophrenia refractory to other medications. It is also effective for the treatment of aggressive behaviour in schizophrenic and demented patients and in the management of psychosis and aggression in Parkinson's disease and Lewy body dementia. ⋯ Clozapine treatment in the elderly requires a careful geriatric assessment. However, its use is strongly limited by the possibility of onset of severe adverse effects such as potentially fatal agranulocytosis, myocarditis and others such as seizures, weight gain and metabolic adverse effects.