Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November - 1 December 2016
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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
Start of referrals
| Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions |
|---|
Lactose of bovine origin Article-31 referral - Review started Lactose of bovine origin Article-31 referral - Timetable for the procedure |
Recommendations by PRAC
| Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free) |
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Ongoing referrals
| Procedure | Status | Update |
|---|---|---|
| Article-31 referral: Gadolinium-containing contrast agents | Under evaluation | PRAC adopted a list of outstanding issues to be addressed by the marketing-authorisation holders. |
| Article-31 referral: Retinoid-containing medicinal products | Under 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 VIII | Under evaluation | PRAC continued its assessment |
| Article-31 referral: Paracetamol-modified release | Under evaluation | PRAC continued its assessment |
| Article-20 procedure: SGLT2 inhibitors (previously Canagliflozin) | Under evaluation | PRAC continued its assessment |