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The PRAC has concluded a review of a meta-analysis of data from three observational studies (1-3) assessing the risk of developing antibodies against recombinant factor VIII products in previously untreated patients (PUPs) with severe haemophilia A (factor VIII level < 1%). Inhibitor development is the most serious and challenging complication in the treatment of haemophilia A.

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13 May 2016; EMA/PRAC/332348/2016

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.

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Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary disease

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of the risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab) and has recommended new measures to minimise this risk. PML is a rare and very serious brain infection caused by John Cunningham (JC) virus. New advice may help early detection of PML and improve patients’ outcomes.

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EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has finalised a review of SGLT2 inhibitors (a class of type 2 diabetes medicines) and has made recommendations to minimise the risk of diabetic ketoacidosis. Diabetic ketoacidosis is a serious complication of diabetes caused by low insulin levels. Rare cases of this condition, including life-threatening ones, have occurred in patients taking SGLT2 inhibitors for type 2 diabetes and a number of these cases have been atypical, with patients not having blood sugar levels as high as expected. Healthcare professionals should therefore consider the possibility of ketoacidosis in patients taking SGLT2 inhibitors who have symptoms consistent with the condition even if blood sugar levels are not high.

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The European Medicines Agency (EMA) has started a review of nasal and mouth sprays containing the antibiotic fusafungine, used to treat infections of the upper airways such as sinusitis (sinus infection) and tonsillitis (inflammation of the tonsils caused by an infection).

The review has been requested by the Italian medicines agency (AIFA) following an increase in the rate of reports of serious allergic reactions including anaphylactic reactions with fusafungine. The majority of the serious allergic reactions were so-called bronchospastic reactions (excessive and prolonged contractions of the airways’ muscles leading to difficulty breathing), which occurred in both adults and children soon after the use of the medicine.

In addition to these safety concerns, AIFA had concerns about the benefit of fusafungine as well as its potential role in promoting antibiotic resistance (the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth). It therefore requested a re-evaluation of the benefit-risk balance for fusafungine-containing medicines.

The EMA will now review the available data on the benefits and risks of medicines containing fusafungine, and issue an opinion on the marketing authorisations of these medicines across the European Union (EU).

While the review is ongoing and pending further communication, patients should speak to their doctor or pharmacist if they have any questions or concerns.

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Start of review of nasal and mouth sprays containing fusafungine

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.

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

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.


References

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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EMA

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.

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EMA, Tysabri

Review confirms small increased cardiovascular risk with daily doses at or above 2,400 mg

European Medicines Agency’s (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen (at or above 2,400 mg per day).

The review clarifies that the risk with high-dose ibuprofen is similar to the risk seen with some other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors and diclofenac.

More information is provided in the following hyperlink:

PRAC recommends updating advice on use of high-dose ibuprofen

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