Review of diabetes medicines called SGLT2 inhibitors started
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.
Start of review of inhaled corticosteroids for chronic obstructive pulmonary disease
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.
Review of Tysabri started
The European Medicines Agency (EMA) has started a review of the multiple sclerosis medicine Tysabri (natalizumab). The aim of the review is to assess whether the advice given to healthcare professionals and patients on how to manage the known risk of progressive multifocal leukoencephalopathy (PML) with this medicine should be revised in the light of new scientific evidence.
PML is a rare brain infection caused by John Cunningham virus (JCV), which has symptoms that may be similar to those of a multiple sclerosis attack, and may result in severe disability or death. It is already known that the risk of PML increases the longer a patient has been receiving Tysabri, especially in patients treated for more than two years. The risk of PML is also higher if the patient used immunosuppressant medicines (medicines that reduce the activity of the immune system) before starting Tysabri, or if the patient has tested positive for antibodies against the virus that causes PML (a sign that the virus may be present in the body).
Scientific evidence on PML is rapidly growing. New data seem to indicate that the methods used to calculate the risk of PML may need to be revised and that testing for PML in patients with no symptoms may need to be performed more frequently than currently recommended. New diagnostic tests have recently been developed and there is a need to assess whether this has an impact on the current prescribing advice.
EMA will now evaluate the available data on the risk of PML with Tysabri with the aim of better defining the risk of PML and identifying further measures to minimise it, and will issue an opinion on whether changes to the marketing authorisation are needed.