EMA committee maintains recommendation to suspend hydroxyethyl-starch solutions for infusion

The Pharmacovigilence Risk Assessment Committee has advised that women planning to become pregnant not be prescribed dolutegravir while the committee assesses associated risks.

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The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed its recommendation to suspend hydroxyethyl-starch (HES) solutions for infusion in the European Union.

HES solutions for infusion are used as plasma volume replacement following acute blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered to be sufficient.

In January 2018, the PRAC recommended suspending the marketing authorisations of HES solutions for infusion on the grounds that they continued to be used in critically ill patients and patients with sepsis, despite restrictions introduced in 2013 to reduce the risk of kidney injury and death in such patients.

However, in April 2018, the European Commission, requested the PRAC to consider whether this decision could result in an unmet medical need and assess the feasibility and likely effectiveness of risk minimisation measures.

At its most recent meeting, held on 14–17 May 2018, the PRAC confirmed its initial recommendations having now assessed the relevant data on these specific aspects. The recommendations will now be sent to the EMA’s Coordination Group for Mutual Recognition and Decentralised Procedures — Human — for consideration at its next meeting.

At its meeting, the PRAC also evaluated the preliminary results from a study that found four cases of birth defects, such as spina bifida in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir.

While it assesses the evidence, the PRAC has advised that dolutegravir should not be prescribed to women seeking to become pregnant, and women who can become pregnant should use effective contraception while taking the drug.

Last updated
The Pharmaceutical Journal, EMA committee maintains recommendation to suspend hydroxyethyl-starch solutions for infusion;Online:DOI:10.1211/PJ.2018.20204889

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