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Information for citizens
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««« IMPORTANT! »»»
Information for citizens

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.

More information on this is included in the hyperlink below:

Start of review of nasal and mouth sprays containing fusafungine

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.

More information:

SGLT2 inhibitors