Идентификация

Review to investigate possible hepatitis B re-activation

The European Medicines Agency (EMA) has started a review of medicines known as direct-acting antivirals used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).

Read more: EMA reviews direct-acting antivirals for hepatitis C

Practice run on public hearings

EMA conducted an internal practice exercise (dry run) in order to test the process and procedures for public hearings. Using a fictional scenario of a safety review, the PRAC experienced how such a hearing would take place. This has enabled EMA to ensure all practical arrangements needed for these hearings are in place and PRAC members to test this new form of interaction. Following this successful simulation, the PRAC is ready to incorporate public hearings as part of its core activities.

Public hearings are a new tool for EMA to engage European Union (EU) citizens in the regulation of medicines and to listen to their views and experiences. The pharmacovigilance legislation has given the PRAC the possibility to hold public hearings as part of certain safety reviews of medicines. Contributions made by the public during these hearings will be considered by the PRAC and inform the Committee’s decision-making.

Public hearings will be held on a case-by-case basis, where the Committee determines that collecting the views of the public would bring added value to its review. The first public hearing could take place as early as the fourth quarter of 2016, as soon as a relevant topic is identified.

More information is available on our 'public hearings' webpage as well as in the rules of procedure for these hearings.

Measures include close monitoring and use of antibiotics to prevent pneumonia

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using the cancer medicine Zydelig (idelalisib) to ensure that it continues to be used as safely as possible. Zydelig is currently authorised in the EU to treat two types of blood cancers called chronic lymphocytic leukaemia (CLL) and follicular lymphoma (one of a group of cancers called non-Hodgkin lymphoma).

Read more: EMA recommends new safety measures for Zydelig

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of Zydelig (idelalisib), confirming that the medicine’s benefits outweigh its risks in the treatment of two types of blood cancers, chronic lymphocytic leukaemia (CLL) and follicular lymphoma. The PRAC however confirmed that there is a risk of serious infections with Zydelig, including Pneumocystis jirovecii pneumonia and has updated recommendations to manage this risk issued at the beginning of the review.

More information on:

PRAC concludes review of Zydelig and issues updated recommendations for use

EMA to review modified-release paracetamol

Measures to minimise risk and reduce harm of overdose to be considered

More information on this is included in the hyperlink below:

Paracetamol-modified release

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

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 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.

More information on this is included in the hyperlink.

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.

More information on this is included in the hyperlink.