Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 7-10 October 2013

News 11/10/2013

PRAC confirms that benefits of all combined hormonal contraceptives continue to outweigh risks

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the risk of venous thromboembolism (VTE or blood clots in veins) with combined hormonal contraceptives (CHCs) and has concluded that the benefits of CHCs at preventing unwanted pregnancies continue to outweigh their risks.

There is no reason for women who have been using CHCs without any problem to stop taking the medicines on the basis of this review. It is important that women are made aware of the risk of VTE and its signs and symptoms, and that doctors take into consideration a woman's individual risk factors when prescribing a contraceptive.

The PRAC recommendation will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) which will adopt an EMA final opinion at its meeting of 18-21 November 2013. The final stage of the review procedure is the adoption by the European Commission of a legally-binding decision applicable in all European Union Member States.

PRAC confirms that hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically-ill patients

The PRAC has completed its review of hydroxyethyl-starch (HES) solutions following an assessment of new information and commitments from companies for additional studies and risk minimisation activities. The Committee confirmed that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients, because of an increased risk of kidney injury and mortality. HES solutions may, however, continue to be used in patients to treat hypovolaemia (low blood volume) caused by acute blood loss, provided that appropriate measures are taken to reduce potential risks and that additional studies are carried out.

A link to more information on the reviews of CHCs and HES is available in the table below.

New referral procedure on valproate started in October 2013

The EMA has started a review of valproate and related substances and their use in pregnant women. Valproate medicines are used for treating epilepsy and bipolar disorder. The review of valproate medicines has been requested by the UK's Medicines and Healthcare Products Regulatory Agency following the publication of new studies suggesting that in some children, problems in development, which can include autism, may be long-lasting.

For an overview of all information available following the meeting of the PRAC, see the table below.


PDF icon Agenda - PRAC draft agenda of meeting 7-10 October 2013

Start of referral procedure

Valproate and related substances

Valproate and related substances

PDF icon Referral notification

PDF icon PRAC list of questions

PDF icon Timetable for the procedure

PDF icon Annex I

Recommendations by PRAC

Combined hormonal contraceptives

Combined hormonal contraceptives

PDF icon Summary of PRAC recommendation

Hydroxyethyl-starch-containing medicines

Article-31 referral: Hydroxyethyl starch solutions for infusion

Article-107i procedure: Hydroxyethyl starch solutions for infusion

PDF icon Summary of PRAC recommendation

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