The PRAC news – October 2013


PRAC confirms that benefits of all combined hormonal contraceptives exceed the risks

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the risk of venous thromboembolism (VTE, 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.

According to this review, 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 also 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 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 hydrohyethil-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 hydrohyethyl-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.

New referral procedure on valproate started in October 2013

The PRAC has started a review of valproate and related substances and their use in pregnant women. Valproate-containing medicines are used for treating epilepsy and bipolar disorders. The review of valproate-containing 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.

Here you may find more about the PRAC recommendations from October 2013.