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The new EU proposal: metformin can be safely used for modera

  The European Medicines Agency (EMA) has also announced that metformin is safe for the treatment of moderate renal impairment in patients with type 2 diabetes, following the FDA's expansion of the indication for metformin and its safe use in patients with mild to moderate renal impairment - Moderate renal injury was defined as a glomerular filtration rate (GFR) of 30-59 mL / min.

  Metformin has been contraindicated in moderately kidney-injured patients because it increases the risk of a rare and serious complication, lactic acidosis, which is associated with increased risk of adverse effects of metformin. However, the use of metformin in patients with moderate renal impairment has been controversial in various countries.

  At the request of the Dutch Medicines Agency, the EMA announced in February this year that a recommendation to use metformin in moderately kidney-damaged patients was reviewed in order to harmonize recommendations across the European Union on the drug.

  After reviewing a number of scientific literature, clinical data, epidemiological studies and clinical guidelines, the EMA announced that patients with moderate renal dysfunction could benefit from metformin. However, patients with severe renal insufficiency (GFR <30 mL / min) still banned metformin.

  EMA announces the updating of the label for metformin, revises its current contraindications, and adds information on dosage, monitoring and preventive measures for patients with renal insufficiency.

  As early as April this year, FDA has announced that metformin can be safely used in patients with moderate renal insufficiency. It is recommended that metformin manufacturers modify their label information to incorporate new drug recommendations and recommend eGFR as a tool for assessing patient renal function and determining whether or not they can take the drug. Prior to this, FDA has been using serum creatinine concentration to assess renal function. EGFR is more effective than serum creatinine because eGFR also includes other important parameters such as age, sex, race and body weight.

  Source: EU Relaxes Metformin Indication to Include Moderate CKD.October 14, 2016.


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