Metformin is an oral medication that helps control blood sugar levels in people with type 2 diabetes. According to Drugs.com, the product is sometimes used in combination with other medications such as insulin, but is not approved for the treatment of type 1 diabetes.
Until now, metformin’s labeling strongly recommended against use in patients with mild to moderate impairment in kidney function “because use of metformin in these patients can increase the risk of developing a serious and potentially deadly condition called lactic acidosis, in which too much lactic acid builds up in the blood.”
In its recent safety announcement, FDA stated that it was asked “to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function, and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin.” After concluding its review, the Agency found that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” As such, FDA states that it is requiring changes to the product’s labeling to reflect its new findings and to provide specific suggestions regarding the use of metformin in patients whose kidneys do not work normally.
In addition, FDA’s safety announcement states that it is also recommending “that the measure of kidney function used to determine whether a patient can receive metformin be changed from one based on a single laboratory parameter (blood creatinine concentration) to one that provides a better estimate of kidney function in patients with kidney disease (i.e., glomerular filtration rate estimating equation (eGFR)).”
FDA Announces Update to Nonproprietary Naming Convention for Biosimilar Products
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...