• Increase font size
  • Default font size
  • Decrease font size
Information for citizens
Information for medical specialists
Information for companies
««« IMPORTANT! »»»
Information for citizens

EMA to review certain injectable medicines to treat allergy

Risks of some methylprednisolone products in patients allergic to cows' milk proteins to be investigated

The European Medicines Agency (EMA) has started a review of certain medicines given by injection to treat severe, rapidly developing (acute) allergic reactions. The medicines involved contain the corticosteroid methylprednisolone as active ingredient. They also include as an additional ingredient lactose (milk sugar), which potentially contains traces of cows' milk proteins that could affect treatment of acute reactions in the small number of highly sensitive patients allergic to these proteins.

More information:

Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

 
Information for citizens

PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C

Review of liver cancer risk not conclusive and further studies are needed

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that patients treated with medicines known as direct-acting antivirals for hepatitis C may be at risk of hepatitis B re-activation. As a result of this review, the PRAC has recommended that, before starting treatment, all patients should be screened for hepatitis B virus; those patients co-infected with hepatitis B and C viruses must then be monitored and managed according to current clinical guidelines.

More information:

PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C

 
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

 
Top