Safety advice on particular drugs or classes of drugs
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| The United States: FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function |
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The U.S. Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use 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. FDA 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.
FDA concluded, from the review of studies published in the medical literature, that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. FDA is requiring changes to the metformin labeling to reflect this new information and provide specific recommendations on the drug’s use in patients with mild to moderate kidney impairment.
FDA is also requiring manufacturers to revise the labeling to recommend 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 renal function (i.e., glomerular filtration rate estimating equation (eGFR)). This is because in addition to blood creatinine concentration, the glomerular filtration rate takes into account additional parameters that are important, such as the patient’s age, gender, race and/or weight.
Healthcare professionals should follow the latest recommendations when prescribing metformin-containing medicines to patients with impaired kidney function. Patients should talk to their health care professionals if they have any questions or concerns about taking metformin.
The labeling recommendations on how and when kidney function is measured in patients receiving metformin will include the following information:
• Before starting metformin, obtain the patient’s eGFR.
• Metformin is contraindicated in patients with an eGFR below 30 mL/minute/1.73 m2.
• Starting metformin in patients with an eGFR between 30-45 mL/minute/1.73 m2 is not recommended.
• Obtain an eGFR at least annually in all patients taking metformin. In patients at increased risk for the development of renal impairment such as the elderly, renal function should be assessed more frequently.
• In patients taking metformin whose eGFR later falls below 45 mL/minute/1.73 m2, assess the benefits and risks of continuing treatment. Discontinue metformin if the patient’s eGFR later falls below 30 mL/minute/1.73 m2.
• Discontinue metformin at the time of or before an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/minute/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm494829.htm
In Hong Kong, there are 121 registered pharmaceutical products containing metformin, which are prescription only medicines. Related news on starting a review of metformin-containing medicines by EMA was posted on the website of Drug Office on 1 February 2016. So far, the Department of Health (DH) has received seven adverse drug reaction cases related to metformin, and two of them involved lactic acidosis after taking the drug. In view of the above FDA announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board. DH will remain vigilant on the conclusion of the review by the EMA and safety updates from other overseas drug regulatory authorities.
Ends/ Saturday, April 09, 2016
Issued at HKT 12:00
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