PRAC reviews known risk of pneumonia with inhaled corticosteroids for chronic obstructive pulmonary disease
|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.
EMA reviews direct-acting antivirals for hepatitis C
Review to investigate possible hepatitis B re-activation
The European Medicines Agency (EMA) has 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).
EMA recommends new safety measures for Zydelig
Measures include close monitoring and use of antibiotics to prevent pneumonia
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) to ensure that it continues to be used as safely as possible. Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called non-Hodgkin lymphoma).