Hydroxyethyl starch (HES) products - increased risk of renal dysfunction and mortality
(B Braun Melsungen AG and Fresenius Kabi Limited) Increased risk of renal dysfunction and mortality in critically ill or septic patients– class 1 action within 48 hours. (EL (13)A/18)
27 June 2013
Class 2 medicines recall
Action within 48 hours
Pharmacy, wholesaler and clinic-level recall
MDR 22-06/13
Product details
B Braun Melsungen AG and Fresenius Kabi Limited
Hydroxyethyl Starch (HES) products
Various PL numbers (see below)
Alert details
B Braun Melsungen AG
| Hydroxyethyl Starch (HES) products | ||
|---|---|---|
| Tetraspan 10% solution for infusion (500ml) | PL 03551/0107 | |
| Tetraspan 6% solution for infusion (500ml) | PL 03551/0106 | |
| Venofundin 60mg/ml solution for infusion (500ml) | PL 03551/0097 |
Fresenius Kabi Limited
| Hydroxyethyl Starch (HES) products | ||
|---|---|---|
| Voluven 10% solution for infusion (500ml) | PL 08828/0207 | |
| Voluven 6% solution for infusion (500ml) | PL 08828/0145 | |
| Volulyte 6% solution for infusion (500ml) | PL 08828/0174 |
All unexpired stock of these products is being recalled to pharmacy, clinic and wholesaler level irrespective of batch number and expiry date.
These products are being withdrawn after results from large randomised clinical trials have reported an increased risk of renal dysfunction and mortality in critically ill or septic patients who received hydroxyethyl starch (HES) compared with crystalloids (simple salt solutions). The UK Commission on Human Medicines (CHM) has concluded that the benefits no longer outweigh the risks.
No further hydroxyethyl starch (HES) products should be dispensed. An alternative resuscitation fluid should be selected according to clinical guidelines.
Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact:
- B Braun Medical Limited (UK) on 01142 259 155
- Fresenius Kabi Limited Customer Services on 01928 533 697
For medical information enquiries please contact:
- B Braun Medical Limited (UK) Medical Information on 01142 259 159
- Fresenius Kabi Limited Medical Information on 01928 533 612 or email pharmacovigilance.GB@fresenius-kabi.com
Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.