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Safety Information

Revised: 12 November 2013

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

Hydroxyethyl starch solutions (Voluven, Volulyte 6%) associated with increased risk of mortality and renal impairment

8 July 2013

Recent publications have indicated an increased risk of mortality as well as renal impairment with the use of hydroxyethyl starch solutions when used in certain patient populations1–4. Patients being treated for sepsis may be at greatest risk.

Products Affected

Hydroxyethyl starch containing products (Voluven and Volulyte 6%) are used for fluid resuscitation or replacement when there is hypovolaemia (low blood volume). These products are also used for the maintenance of adequate circulating blood volume during surgical procedures.

Additional Information and Advice

The sponsor, Fresenius Kabi, is updating the data sheets stating that these products should not be used in patients with:

This is in addition to other contraindications including patients:

In critically ill patients, crystalloids or blood should be used. Voluven or Volulyte 6% should only be used if crystalloids are not sufficient to stabilise the patient and if the anticipated benefit justifies the risk outlined in the recent literature.

Healthcare professionals should consider a dose reduction depending on the actual needs and severity of the patient’s condition, with the lowest possible effective dose given. Renal function should be monitored in all patients and hydroxyethyl starch solutions should be discontinued at the first sign of renal injury.

Regulator Actions

Medsafe is continuing to review this safety concern and will provide further information once this review is complete.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

Medsafe cannot give advice about an individual's medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

How to report an adverse reaction

References
  1. Perel P, Roberts I, Ker K. 2013. Colloids versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database of Systematic Reviews 2: CD000567
  2. Perner A, Haase N, Guttormsen AB, et al. 2012. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. New England Journal of Medicine 367: 124–34
  3. Guidet B, Martinet O, Boulain T, et al. 2012. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: The CRYSTMAS study. Critical Care 16: R94
  4. Wiedermann CJ, Joannidis M. 2012. Mortality after hydroxyethyl starch 130/0.4 infusion: an updated meta-analysis of randomized trials. Swiss Medical Weekly 142: w13656

Update to Original Communication

12 November 2013

The safety of all hydroxyethyl starch containing medicines was reviewed by the Medicines Adverse Reactions Committee (MARC) in September 2013. The MARC considered that use in surgical patients did not raise any safety concerns. The MARC noted that the meta-analyses and clinical studies had limitations sufficient to preclude a firm conclusion being made on the benefits and risks of these medicines in critically ill patients.

The MARC considered that there were differences in the effects of different starches that should be investigated further and recommended that a statutory benefit risk review should be performed.

The supplier of Starquin200 (solution for infusion 6% and 10%) has withdrawn this product from the New Zealand market.

Minutes of the 155th MARC meeting – 12 September 2013

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