Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 October 2014

News 10/10/2014

European Medicines Agency updates on key outcomes of the meeting

The Pharmacovigilance Risk Assessment Committee (PRAC) concluded three safety reviews at its October meeting.

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

The Committee has recommended further restrictions on the use of valproate medicines due to the risk of malformations and developmental problems in children exposed to valproate in the womb. The PRAC also recommended that doctors who prescribe valproate provide women with full information to ensure that they understand the risks and to support their treatment decisions.

Valproate is used to treat epilepsy and bipolar disorder. Some valproate medicines have also been used in certain EU Member States to prevent migraine attacks.

More information is available in the table below.

PRAC review does not confirm increase in heart problems with testosterone medicines

The PRAC review did not find consistent evidence that the use of testosterone in its authorised indication in men who do not produce enough testosterone (a condition known as hypogonadism) increases the risk of heart problems. The Committee considered that the benefits of testosterone continue to outweigh its risks but recommended that testosterone-containing medicines should only be used where lack of testosterone has been confirmed by signs and symptoms as well as laboratory tests.

More information is available in the table below.

PRAC recommends further measures to minimise risk of blood vessel blockage with Iclusig

The Committee completed its review of the cancer medicine Iclusig (ponatinib), which aimed to examine the risk of blood clots or blockage of the arteries or veins and to assess whether further measures were needed to minimise this risk.

The PRAC considered that the benefits of Iclusig continue to outweigh its risks; however, it recommended that the product information for patients and healthcare professionals should be updated with strengthened warnings, particularly about the risk of blood clots and blockages of the arteries.

More information is available in the table below.

Five days left to respond to the consultation on public hearings

The EMA has launched a public consultation on PDF icon draft rules of procedures for public hearings to be held by the PRAC. Comments are invited until 15 October 2014 and should be sent to using the Microsoft Office document icon comments submission form .

The rules of procedures describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings.

Public hearings are a new tool for the EMA to engage EU citizens in the regulatory process of the supervision of medicines and to listen to their views and experiences. The contributions made by the public during a public hearing will be considered by the PRAC and will inform the Committee's decision-making.


PDF icon Agenda - PRAC draft agenda of meeting 6-9 October 2014

Recommendations by PRAC

Valproate and related substances

Article-31 referral: Valproate and related substances

PDF icon Summary of PRAC recommendation

Testosterone-containing medicines

Article-31 referral: Testosterone-containing medicines

PDF icon Summary of PRAC recommendation


Article-20 procedure: Iclusig

PDF icon Summary of PRAC recommendation

Related content

How useful was this page?

Add your rating
2 ratings