(U.S.) FDA Alert: Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Monday, April 11, 2016

(U.S.) FDA Alert: Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function



Revised Warnings

  See the FDA Drug Safety Communication for additional information, including a data summary and a list of metformin-containing drugs.

 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. 
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

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