News and Educations

Meeting highlights from the PRAC meeting in November 2016


At its meeting in November 2016, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded the safety review of direct-acting antivirals for treatment of hepatitis C and started the safety review of certain injectable medicines for treatment of allergic reactions.

PRAC warns of risk of hepatitis B re-activation in patients treated 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 hepatocellular carcinoma (liver cancer) in patients treated with these medicines and concluded that further studies should be carried out before firm conclusions can be drawn.

More information is provided on HALMED's website.

Review started on certain injectable medicines to treat allergic reactions

The PRAC started a review of certain medicines given by injection to treat 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 on HALMED's website.

PRAC continued the review within referral procedures for gadolinium-containing contrast agents, factor VIII medicines, modified- and prolonged-release paracetamol medicines and SGLT2 inhibitors.

More information on the PRAC November 2016 meeting can be found here.