FDA advice on metformin is curbing its use

The Food and Drug Administration (headquarters pictured) has approved a new drug for heart failure that has “overwhelming benefit” for patients, according to the researchers who trialled the medicine

The US Food and Drug Administration (FDA) states that metformin is contraindicated in people with serum creatinine levels over a certain threshold. However, the criteria are considered overly conservative by bodies such as the American Diabetes Association, which argues that estimated glomerular filtration rate (eGFR) is a better measure of renal function.

To investigate, researchers examined data on more than 11.5 million participants taking oral diabetes drugs (JAMA Internal Medicine, online, 5 January 2015)[1]
. Among those with an eGFR of 30–60mL/min — at which metformin is generally contraindicated but professional guidelines support cautious use — metformin was used by only around 50% of patients.

The low rate of metformin use is caused, at least in part, by the discrepancy between the FDA label and clinical guidelines, the researchers believe. They conclude: “The FDA is overdue to revisit the contraindication to metformin use in patients with renal insufficiency.” 


[1] Flory JH & Hennessy S. Metformin use reduction in mild to moderate renal impairment: Possible inappropriate curbing of use based on Food and Drug Administration contraindications. JAMA Internal Medicine 2015. doi:10.1001/jamainternmed.2014.6936.

Last updated
The Pharmaceutical Journal, PJ, 24 January 2015, Vol 294, No 7846;294(7846):DOI:10.1211/PJ.2015.20067599

You may also be interested in