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The PRAC is investigating the cancer medicine docetaxel following cases of neutropenic enterocolitis in patients in France. Most of the patients were being treated for operable breast cancer.

A preliminary assessment by the PRAC indicates that the frequency of this known side effect has not increased in the last two years. A thorough evaluation of available data is being carried out and final conclusions will be published once the review has been completed.

More detailed information on:

Pharmacovigilance Risk Assessment Committee (PRAC): 6-9 March 2017

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of Uptravi (selexipag), following the deaths of 5 patients taking the medicine in France. Based on a preliminary review of available data, EMA advises that Uptravi may continue to be used, but use must be in line with the current prescribing information.

The PRAC will further explore all available data. Once the review is completed, final conclusions will be published.

More information:

EMA reviewing safety of Uptravi for pulmonary arterial hypertension (updated)

EMA to review certain injectable medicines to treat allergy

Risks of some methylprednisolone products in patients allergic to cows' milk proteins to be investigated

The European Medicines Agency (EMA) has 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.

More information:

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

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

Review of liver cancer risk not conclusive and further studies are needed

EMA’s Pharmacovigilance Risk Assessment Committee (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, before starting treatment, all patients should be screened for hepatitis B virus; those patients co-infected with hepatitis B and C viruses must then be monitored and managed according to current clinical guidelines.

More information:

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

The PRAC has concluded a review of a meta-analysis of data from three observational studies (1-3) assessing the risk of developing antibodies against recombinant factor VIII products in previously untreated patients (PUPs) with severe haemophilia A (factor VIII level < 1%). Inhibitor development is the most serious and challenging complication in the treatment of haemophilia A.

More information on this is included in the hyperlink below:

13 May 2016; EMA/PRAC/332348/2016

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