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Pharmacovigilance / «Medical specialists»

Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function

Recommendations for patients with kidney impairment updated in product information

The European Medicines Agency (EMA) has concluded that metformin-containing medicines can now be used in patients with moderately reduced kidney function (GFR [glomerular filtration rate]=30–59 ml/min) for the treatment of type 2 diabetes. The product information for these medicines will be updated to revise the current contraindication and give information about doses, monitoring and precautions in patients with reduced kidney function.

The recommendations are the result of a review by EMA of metformin-containing medicines following concerns that current scientific evidence does not justify a contraindication in patients with moderate reduction of kidney function. The current product information also varies between countries and products in the EU and is no longer consistent with clinical guidelines.

More information on the following hyperlink:

Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function

 
Information for medical specialists

Effectiveness of measures for pregnancy prevention and for minimising possible risk of neuropsychiatric disorders to be evaluated

The European Medicines Agency (EMA) has started a review of retinoid medicines to evaluate measures currently in place for pregnancy prevention and for minimising the possible risk of neuropsychiatric disorders.

Retinoids (which include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin) are taken by mouth or applied as creams or gels to treat several conditions mainly affecting the skin, including acne and psoriasis. Some retinoids are also used to treat certain forms of cancer.

More information on:

Retinoid-containing medicinal products

 
Information for medical specialists

The PRAC started a review of medicines containing factor VIII to evaluate the risk of developing inhibitor proteins in patients starting treatment for haemophilia A. This follows the recent publication of a study whose authors suggested that inhibitors develop more frequently in patients receiving factor VIII medicines made by DNA recombinant technology than in those receiving factor VIII medicines derived from blood.

More information is available on:

Factor VIII

 
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