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Information for citizens

The PRAC has concluded a review of a meta-analysis of data from three observational studies (1-3) assessing the risk of developing antibodies against recombinant factor VIII products in previously untreated patients (PUPs) with severe haemophilia A (factor VIII level < 1%). Inhibitor development is the most serious and challenging complication in the treatment of haemophilia A.

More information on this is included in the hyperlink below:

13 May 2016; EMA/PRAC/332348/2016

 
Information for citizens

EMA reviews direct-acting antivirals for hepatitis C

On 17 March 2016, the European Medicines Agency (EMA) started a review of medicines known as direct-acting antivirals used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).

Direct-acting antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) are important medicines for the treatment of chronic hepatitis C and can be used without interferons, which are less well tolerated. Until recently, interferons were part of treatment regimens for hepatitis C. Interferons are known to act against both hepatitis B and C viruses, which may be present at the same time in some patients.

The review was triggered by reports of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C. Hepatitis B re-activation refers to a return of active infection in a patient whose hepatitis B infection had been inactive. The review will assess the extent of hepatitis B re-activation in patients treated with direct-acting antivirals for hepatitis C and evaluate whether any measures are needed to optimise the treatment.

In addition, in April 2016 data from a study1 became available regarding the risk of liver cancer (hepatocellular carcinoma) coming back in patients who were treated with direct-acting antivirals for hepatitis C. The study suggested that these patients were at risk of their cancer coming back earlier than patients with hepatitis C who were not treated with direct-acting antivirals. The scope of the ongoing review has therefore been extended to also assess the risk of liver cancer with these medicines. While the review is ongoing, patients should speak to their doctor or pharmacist if they have any questions or concerns.

More information on this is included in the hyperlink below:

EMA reviews direct-acting antivirals for hepatitis C

 
Information for citizens

Review finds no differences in this risk between products

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the known risk of pneumonia (infection of the lungs) with inhaled corticosteroid-containing medicines when used to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term disease of the lungs in which the airways and air sacs in the lungs become damaged or blocked, leading to breathing difficulties. Corticosteroids are widely used in the European Union (EU) to treat COPD and are usually taken by inhalation using an inhaler device.

An update of the product information is being recommended to adequately reflect the current knowledge. There is no change to the way these medicines should be used; however, doctors and patients should be vigilant for signs and symptoms of pneumonia in patients with COPD as the clinical features of pneumonia overlap with those of exacerbations of the underlying disease.

More information on this is included in the hyperlink below:

Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease

 
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