REGULATORY
Infographic : key events
A summary of the key European regulatory events regarding hydroxyethyl starches is presented
Regulatory timeline
2012
Event Publication of 6S , CHEST and VISEP studies
Outcome Review of data led to key regulatory decisions by the European Medicines Agency
Pharmacovigilance Risk Assessment Committee ( PRAC ) review conducted in light of safety concerns 1
2013
Event PRAC recommendation
Appeal against decision by MA holders
Change in indication
Additional contraindications cited
Added adverse effects
Restriction on patient populations
Additions to guidance
Outcome Recommendation to suspend marketing authorisations for all HES products in all patient populations 2
Revised recommendation to allow EU-wide use of HES in restricted patient populations and revised product information issued 3
Hypovolaemia ( treatment / prophylaxis ): a crystalloid should first be given
Contraindicated in critical illness ( including sepsis ), burns , renal impairment / replacement , organ transplant , severe coagulopathy ; impaired hepatic function
Renal / hepatic injury
HES to only be used during the first 24h of fluid resuscitation ; not recommended in open heart surgery ; other treatment options should be considered in trauma and surgery because of long-term safety issues
Use HES at lowest effective dose for shortest possible time
Monitor kidney function for at least 90 days and discontinue use at first sign of renal injury
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