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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
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1 to 1 of 1 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