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Information for citizens

The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of HPV vaccines to further clarify aspects of their safety profile. Like all medicines the safety of these vaccines is monitored by the PRAC. The review will look at available data with a focus on rare reports of two conditions: complex regional pain syndrome and postural orthostatic tachycardia syndrome. The review does not question that the benefits of HPV vaccines outweigh their risks.

More information:

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 July 2015

Pharmacovigilance / «Citizens»

Risk of diabetic ketoacidosis to be examined

The European Medicines Agency (EMA) has started a review of canagliflozin, dapagliflozin and empagliflozin, which are medicines known as SGLT2 inhibitors used to treat type 2 diabetes. The aim of the review is to evaluate the risk of diabetic ketoacidosis, a serious condition that usually develops in people with type 1 diabetes when insulin levels are too low.

The review of SGLT2 inhibitors has been requested by the European Commission following reports1 of diabetic ketoacidosis in patients on SGLT2 inhibitor treatment for type 2 diabetes. All cases were serious and some required hospitalisation. Although diabetic ketoacidosis is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased. These uncharacteristic blood levels could delay diagnosis and treatment.

EMA will now review all available data on the risk of diabetic ketoacidosis with SGLT2 inhibitors and consider whether any changes are needed in the way these medicines are used in the EU.

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SGLT2 inhibitors

Information for citizens

The European Medicines Agency (EMA) has started a review of inhaled corticosteroid-containing medicines used to treat chronic obstructive pulmonary disease (COPD). COPD is a long-term inflammatory disease of the lungs in which the airways and air sacs in the lungs become damaged or blocked. Corticosteroids are widely used in the European Union (EU) to treat COPD and are usually taken by inhalation using an inhaler device.

The review of inhaled corticosteroid-containing medicines has been requested by the European Commission to evaluate the risk of pneumonia (inflammation of the lungs) when these medicines are used for COPD. The risk of pneumonia with these medicines is known and was first identified in 2007 when a study showed that patients treated with an inhaled corticosteroid, fluticasone, were at higher risk of developing pneumonia than those given placebo (dummy treatment).1 Since then, new studies of individual inhaled corticosteroids and combined study results (meta-analyses) on the class of inhaled corticosteroids have provided further data on the risk of pneumonia and it was considered necessary that a thorough review be performed to further characterise this risk.

EMA will now review all available data on the risk of pneumonia with inhaled corticosteroids for COPD and consider the need to update the existing prescribing advice across the EU.


1. Calverley PM, Anderson JA, Celli B, et al. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. The New England journal of medicine 2007;356:775-89.

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