Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2016

News 15/04/2016

In April, the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) started a new safety review, extended the scope of an ongoing review procedure and agreed the rules of procedure for public hearings.

PRAC reviews diabetes medicine canagliflozin

The PRAC has started a review of the diabetes medicine canagliflozin after an increase in amputations mostly affecting toes was observed in an ongoing clinical trial called CANVAS. Canagliflozin is the active substance in two centrally authorised diabetes medicines, Invokana and Vokanamet (which also contains metformin).

More information is provided in the table below.

PRAC extends the scope of its review on direct-acting antivirals for hepatitis C

The PRAC also extended the scope of its ongoing safety review of medicines known as direct-acting antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi, Viekirax) used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).

At its previous meeting in March, the Committee had initiated a review following cases of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C.

In April 2016, data from a study became available regarding the risk of liver cancer (hepatocellular carcinoma) coming back in patients who were treated with these medicines. The study suggested that these patients were at risk of their cancer coming back earlier than patients with hepatitis C who were not treated with direct-acting antivirals. The scope of the ongoing review has therefore been extended to also assess the risk of liver cancer with these medicines.

More information is provided in the table below.

Rules of procedure on public hearings on selected safety reviews adopted

The PRAC has adopted the final rules of procedure for public hearings to be held by the Committee. The rules of procedure describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings. Public hearings are a new tool for EMA to engage European Union (EU) citizens in the supervision of medicines and to listen to their views and experiences.

More information is provided in a separate press release.


PDF icon Agenda - PRAC draft agenda of meeting 11-14 April 2016

Start of referral


Article-20 procedure: Canagliflozin

PDF icon Review started

Extension of scope

Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)

Article-20 referral: Direct-acting antivirals for treatment of hepatitis C (interferon-free)

PDF icon Updated review started
PDF icon Addendum to referral notification
PDF icon Addendum to PRAC list of questions
PDF icon Updated timetable for the procedure

Ongoing referrals

Article-31 referral: Gadolinium-containing contrast agentsUnder evaluationPRAC continued its assessment
Article-20 referral: ZydeligUnder evaluationPRAC continued its assessment

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