American journal of therapeutics
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In this study, we evaluated the efficacy and safety of acetazolamide in the management of chronic metabolic alkalosis in neonates and infants with chronic respiratory insufficiency. A retrospective chart review of 90 patients treated with acetazolamide between 2006 and 2007 admitted to the neonatal intensive care unit was performed. Blood gases and electrolytes obtained at baseline and by 24 hours after acetazolamide administration were compared. ⋯ Uncompensated respiratory acidosis developed in 4 (3.1%) treatment courses. Acetazolamide may be effective in decreasing serum bicarbonate in carefully selected patients. Its use and safety as an adjunctive therapy for chronic metabolic alkalosis in neonates and infants with chronic respiratory insufficiency needs further study.
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The Food and Drug Administration's MedWatch system--a voluntary surveillance program--received 600,000 adverse event reports on marketed drugs and devices in 2011. The Food and Drug Administration credits the MedWatch system with improving awareness, and expediting early detection, of drug and device risks and in illuminating the adoption of medical treatments. Reporting bias has been acknowledged as a limitation of the MedWatch system. ⋯ More than 25% of the names of reported suspect products were inaccurate, and 31% of suspect product start dates were inaccurate. Higher levels of completion and accuracy were associated with reports filed closer to the date when the adverse event was observed. Implications of the results and suggested improvements are discussed.