Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2016

News 02/12/2016

PRAC starts a safety referral and concludes one

At its meeting this week, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded a safety review and started a new one. It also discussed two ongoing referrals.

PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C

The PRAC has confirmed that patients treated with medicines known as direct-acting antivirals for hepatitis C may be at risk of hepatitis B re-activation. As a result of this review, the PRAC has recommended that all patients should be screened for hepatitis B virus before starting treatment; those patients co-infected with hepatitis B and C viruses must then be monitored and managed according to current clinical guidelines.

The PRAC also reviewed the available data on liver cancer (hepatocellular carcinoma) in patients treated with direct-acting antivirals and concluded that further studies should be carried out before firm conclusions can be drawn.

More information is provided in the public health communication below.

Review started on certain injectable medicines to treat allergic reactions

The PRAC started a review of certain medicines given by injection to treat severe, rapidly developing (acute) allergic reactions. The medicines involved contain the corticosteroid methylprednisolone as active ingredient. They also include as an additional ingredient lactose (milk sugar), which potentially contains traces of cows' milk proteins that could affect treatment of acute reactions in the small number of highly sensitive patients allergic to these proteins.

The review is triggered by reports of reactions to the medicines themselves in patients being treated for allergic conditions with these medicines who were also allergic to cows' milk proteins.

More information is provided in the public health communication 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 in January 2017.

Agenda

PDF iconAgenda - PRAC draft agenda of meeting 28 November - 1 December 2016

Start of referrals

Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

Article-31 referral: Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

PDF iconReview started

PRAC list of questions

PDF iconTimetable for the procedure

PDF iconReferral notification

Recommendations by PRAC

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

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

PDF iconSummary of PRAC recommendation

Ongoing referrals

ProcedureStatusUpdate
Article-31 referral: Gadolinium-containing contrast agentsUnder evaluationPRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.
Article-31 referral: Retinoid-containing medicinal productsUnder evaluation

PRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders.

PRAC also agreed to convene a targeted meeting to consult patients and healthcare professionals in the context of this referral. The list of questions for these stakeholders will be adopted in January 2017.

Article-31 referral: Factor VIIIUnder evaluationPRAC continued its assessment
Article-31 referral: Paracetamol-modified releaseUnder evaluationPRAC continued its assessment
Article-20 procedure: SGLT2 inhibitors (previously Canagliflozin)Under evaluationPRAC continued its assessment

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