PRAC News – March 2016


PRAC concludes the review of the known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease

The 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). Corticosteroids are widely used in the European Union (EU) to treat COPD and are usually taken by inhalation using an inhaler device.

The PRAC review confirms that COPD patients treated with inhaled corticosteroids are at increased risk of pneumonia; however the Committee’s view is that the benefits of inhaled corticosteroids continue to outweigh their risks. The PRAC also checked whether there were any differences in the risk of pneumonia between these products, and did not find conclusive evidence of such a difference. Pneumonia remains a common side effect for all of them.

More information is available on the HALMED portal.

PRAC recommends new safety measures for Zydelig

The Committee started its review of Zydelig (idelalisib) and issued, as a precaution, provisional advice for doctors and patients using the cancer medicine, to ensure that it continues to be used as safely as possible while the review is ongoing.

The European Medicines Agency (EMA) announced the start of this safety review on Friday 11 March, after a higher rate of serious adverse events was observed in three clinical trials, using the medicine in different ways from currently authorised, among patients receiving Zydelig compared with placebo (a dummy treatment). Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma.

Zydelig has not been placed on the Croatian market.

More information is available on the HALMED portal.

PRAC reviews direct-acting antivirals for hepatitis C

The PRAC also started a review of medicines known as direct-acting antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus). The review follows cases 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.

More information is available on the HALMED portal.

PRAC reviews gadolinium contrast agents used in MRI scans

The Committee started a review of the risk of gadolinium deposition in brain tissue following the use of gadolinium contrast agents in magnetic resonance imaging (MRI) scans. Gadolinium contrast agents are diagnostic products that may be given to patients before or during MRI scans to help doctors obtain better images of organs and tissues.

More information is available on the HALMED portal.

More information on the March 2016 PRAC meeting can be found here.