Diabetes drug also applicable to kidney failure
The diabetes drug metformin has long been considered contraindicated in patients with impaired renal function. However, the Committee for Medicinal Products (CHMP) of the European Medicines Agency (EMA) has now decided in favor of lower restrictions on use, reports the Federal Institute for Drugs and Medical Devices (BfArM).
Just over a year ago, based on the assessment of new data on the safety of metformin use in patients with renal insufficiency, the limit for creatinine clearance, at which metformin is contraindicated, was reduced by a quarter, according to the BfArM. Now the application has been extended to patients with impaired renal function.
The diabetes drug metformin may be used in future in patients with impaired kidney function. (Image: Andrey Popov / fotolia.com)The new risk assessment procedure, which is in the. October, the EMA has led to "the limit for creatinine clearance beyond which metformin is contraindicated even further, down to <30 ml / min (or eGFR <30 ml / min /1.73m2), lower, "reports the BfArM. Accordingly, patients with grade 3b renal impairment may now be treated with metformin. However, the dose should be adjusted according to the kidney function, the kidney function regularly checked and some other precautions must be observed, according to the BfArM. "For patients with severe renal insufficiency (GFR less than 30 ml / min), the contraindication remains," the Federal Institute continues. According to the BfArM, the previous contraindication for metformin in patients with renal insufficiency was the increased risk of lactic acidosis (hyperacidity of the blood due to the accumulation of lactic acid) in the case of existing kidney dysfunction. In the patient group with moderate renal impairment, which in the future should also benefit from treatment with metformin, this risk is minimized by clear recommendations. These include, for example, dose adjustment according to renal function, control of renal function before and regularly during treatment, and the required special attention in situations where renal function is deteriorating acutely. "The Specialist and Use Information of medicinal products containing metformin approved in Germany will be adapted to the new recommendations," the BfArM continues. (Fp)