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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.

More information on this is included in the hyperlink below:

Start of review of nasal and mouth sprays containing fusafungine

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

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

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of the risk of serious side effects with these medicines, including the risk of breathing problems.

The PRAC recommended specifically that:

  • Codeine should be contraindicated in children below 12 years. This means it must not be used in this patient group.
  • Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have problems with breathing.
  • All liquid codeine medicines should be available in child-resistant containers to avoid accidental ingestion.

The effects of codeine are due to its conversion into morphine in the body. Some people convert codeine to morphine at a faster rate than normal, resulting in high levels of morphine in their blood. High levels of morphine can lead to serious effects, such as breathing difficulties.

Read more on the following hyperlink:

PRAC recommends restrictions on the use of codeine for cough and cold in children

 

PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines Medicines can still be given for their approved uses,
with new restrictions

 EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing the antihistamine hydroxyzine. This follows concerns over the risk of possible effects on heart rhythm with these medicines, which are available in most EU countries. Their approved uses (indications) vary considerably between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and for treatment of sleep disorders.

More information on this, is included in the hyperlink below.

 

PRAC recommendations to be considered by CHMP for final opinion

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of Corlentor/Procoralan (ivabradine) and has made recommendations aimed at reducing the risk of heart problems, including heart attack and bradycardia (excessively low heart rate), in patients taking the medicine. Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.

The PRAC made recommendations about the resting heart rate of patients before starting treatment or when the dose is adjusted, recommendations on when treatment should be stopped and recommendations regarding use with other medicines. Because patients treated with Corlentor/Procoralan are at an increased risk of developing atrial fibrillation (a heart condition that causes an irregular and often abnormally fast heart rate), the PRAC recommended monitoring for this condition in patients treated with Corlentor/Procoralan. In addition, the PRAC recommended that, when used for angina, Corlentor/Procoralan should only be used to alleviate symptoms as the available data do not indicate that the medicine provides benefits on outcomes such as reducing heart attack or cardiovascular death (death due to heart problems).

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The PRAC has recommended strengthening the restrictions on the use of valproate medicines due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated. Women for whom valproate is the only option after trying other treatments, should use effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions.

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The PRAC has completed an EU-wide review of testosterone-containing medicines following concerns over serious side effects on the heart and blood vessels, including heart attack. The PRAC review did not find consistent evidence that the use of testosterone in men who do not produce enough testosterone (a condition known as hypogonadism) increases the risk of heart problems. The committee considered that the benefits of testosteronecontinue to outweigh its risks but recommended that testosterone-containing medicines should only be used where lack of testosterone has been confirmed by signs and symptoms as well as laboratory tests.

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