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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016

In March, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded one safety review. It also discussed three new safety reviews. For one of these, regarding the cancer medicine Zydelig, the PRAC proposed provisional measures, as a precaution, to protect patients while the medicine is being reviewed.

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.

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