Safety Alerts & Recalls

What does this mean?

Metformin is an important medicine for controlling Type 2 diabetes. You should continue to take your metformin containing medicine as directed by your healthcare provider.

This alert is not likely to affect people who are currently taking a metformin containing product. This change to the metformin prescribing information is important for people with Type 2 diabetes whose kidneys do not function as well or for people whose may have some kidney impairment in the future. This labeling change gives healthcare providers the option to prescribe metformin to patients with mild impairment in kidney function and to some patients with moderate impairment in kidney function.

If you are currently taking or about to take a medicine containing metformin, here are some important things to remember:

--- Tell your health care provider if you have severe kidney problems.

--- If you are going to have dye injected into a vein for an X-ray procedure, be sure to remind your healthcare provider or technician that you are taking metformin.

--- Do not take metformin if you have severe kidney problems.

--- Read the patient Medication Guide or Patient Package Insert you receive with your prescription for a metformin-containing medicine. It explains the benefits and risks associated with the use of the medicine.

--- Talk to your health care professional if you have any questions or concerns about metformin.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: http://www.fda.gov/Safety/MedWatch/default.htm

FDA Expands Use of Metformin-Containing Drugs in Certain Patients with Reduced Kidney Function

The U.S. Food and Drug Administration (FDA) has requested labeling changes regarding the recommendations for the use of metformin-containing medicines for diabetes in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. The new labeling will expand the use of metformin to include some patients with mild to moderate kidney function.

The FDA was asked to review several 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. The FDA has concluded from the review that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. They are also recommending that the measure of kidney function used to determine whether a patient can receive metformin be changed to one that provides a better estimate of kidney function in patients with kidney disease (i.e., glomerular filtration rate estimating equation (eGFR)).

The prescribing information for all metformin-containing medicines will be updated with this new information.

For more information, please visit: more information here

Source: FDA
Publication Date: 2016-05-02
Last Updated: 2016-06-02
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