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AHRQ Research Studies
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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
Results
1 to 2 of 2 Research Studies DisplayedLipska KJ, Flory JH, Hennessy S
Citizen petition to the US Food and Drug Administration to change prescribing guidelines: The metformin experience.
Although healthcare professionals rarely submit citizen petitions, they can exert a powerful impact on the labeling requirements for drugs. Metformin is one such example. The authors filed 2 petitions to the FDA, asking the FDA to change the label and to relax the renal contraindications. In 2016, the FDA issued a safety communication that partially granted our requests by requiring the manufacturers of metformin to change the labeling of metformin in several ways.
AHRQ-funded; HS023898.
Citation: Lipska KJ, Flory JH, Hennessy S .
Citizen petition to the US Food and Drug Administration to change prescribing guidelines: The metformin experience.
Circulation 2016 Nov 1;134(18):1405-08. doi: 10.1161/circulationaha.116.023041.
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Keywords: Medication, Medication: Safety, Adverse Drug Events (ADE), Kidney Disease and Health, Diabetes
Brookhart MA, Freburger JK, Ellis AR
Comparative short-term safety of sodium ferric gluconate versus iron sucrose in hemodialysis patients.
Despite different pharmacologic properties, little is known about the comparative safety of sodium ferric gluconate versus iron sucrose in hemodialysis patients. This study found that, overall, the 2 iron formulations studied exhibited similar safety profiles; however, ferric gluconate was associated with a slightly decreased risk for infection-related outcomes compared to iron sucrose among patients with a hemodialysis catheter.
AHRQ-funded; 290200500401.
Citation: Brookhart MA, Freburger JK, Ellis AR .
Comparative short-term safety of sodium ferric gluconate versus iron sucrose in hemodialysis patients.
Am J Kidney Dis 2016 Jan;67(1):119-27. doi: 10.1053/j.ajkd.2015.07.026.
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Keywords: Comparative Effectiveness, Kidney Disease and Health, Medication: Safety, Outcomes, Adverse Drug Events (ADE)