Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2016

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12/02/2016

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 February 2016

PRAC concludes three safety reviews

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded three safety reviews at its February meeting.

Updated recommendations to minimise the risk of the rare brain infection PML with Tysabri

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

More information is available in the table below.

PRAC recommends stopping the marketing of fusafungine nose and mouth sprays

The Committee recommended that the marketing authorisation for fusafungine-containing medicines be revoked, so the medicines can no longer be marketed in the European Union (EU). This follows a review by the PRAC which concluded that the benefits of fusafungine did not outweigh its risks, particularly the risk of serious allergic reactions. Fusafungine is an antibiotic and anti-inflammatory nose and mouth spray used to treat upper airway infections such as rhinopharyngitis (common cold).

More information is available in the table below.

SGLT2 inhibitors: recommendations to minimise risk of diabetic ketoacidosis

The PRAC 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. There are currently three SGLT2 inhibitors authorised in the EU (canagliflozin, dapagliflozin and empagliflozin).

More information is available in the table below.

Ongoing referrals

More information on other ongoing referrals is included in the table below.

Information on all topics discussed by the PRAC is available below in the agenda for the meeting. A record of the discussions held this week will be provided in the minutes of this meeting, which will be published following the next PRAC meeting scheduled to take place from 14-17 March. 

Agenda

 
Agenda - PRAC draft agenda of meeting 8-11 February 2016

  

Recommendations by PRAC

Tysabri

Article-20 procedure: Tysabri

 

Summary of PRAC recommendation

 

Fusafungine containing medicinal products for oromucosal and nasal use

Article-31 procedure: Fusafungine containing medicinal products for oromucosal and nasal use

 

Summary of PRAC recommendation

 

SGLT2 inhibitors

Article-20 procedure: SGLT2 inhibitors

 

Summary of PRAC recommendation

 

Ongoing referrals

ProcedureStatusUpdate
Article-31 referral: Inhaled corticosteroids containing medicinal products indicated in the treatment of chronic obstructive pulmonary diseaseUnder evaluationPRAC continued its assessment.

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