ADR that result in revision of patient information
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| European Union: PRAC recommends suspending marketing authorisations for infusion solutions containing hydroxyethyl-starch |
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has concluded following a review of the available evidence that the benefits of infusion solutions containing hydroxyethyl-starch (HES) no longer outweigh their risks and therefore recommended that the marketing authorisations for these medicines be suspended.
Infusion solutions containing HES are medicines mainly used to replace lost blood volume in hypovolaemia (low blood volume caused by dehydration or blood loss) and hypovolaemic shock (a steep fall in blood pressure caused by drop in blood volume). They are used in critically ill patients including patients with sepsis (bacterial infection of the blood) or burn or trauma injuries, or patients who are undergoing surgery.
The review of infusion solutions containing HES was triggered by the German medicines agency, the Federal Institute for Drugs and Medical Devices (BfArM), following three recent studies that compared HES with other products used for volume replacement called crystalloids in critically ill patients. The studies showed that patients with severe sepsis treated with HES were at a greater risk of kidney injury requiring dialysis. Two of the studies also showed that in patients treated with HES there was a greater risk of mortality. The PRAC was therefore requested to assess the available evidence and how it impacts on the risk-benefit balance of HES infusion solutions in the management of hypovolaemia and hypovolaemic shock.
The PRAC assessed data from the scientific literature and the data submitted by the companies, and took advice from a group of external experts. The PRAC was of the opinion that, when compared with crystalloids, patients treated with HES were at a greater risk of kidney injury requiring dialysis and had a greater risk of mortality. The PRAC also considered that the available data only showed a limited benefit of HES in hypovolaemia, which did not justify its use considering the known risks. The PRAC therefore concluded that the marketing authorisations for these medicines be suspended.
The suspension should remain in place unless the marketing authorisation holder can provide convincing data to identify a group of patients in whom the benefits of the medicines outweigh their risks.
Please refer to the following website at EMA for details:
http://www.ema.europa.eu/../news_detail_001814.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are 6 registered pharmaceutical products containing hydroxyethyl starch and are all non-prescription medicines. The Drug Office of Department of Health has contacted the registration certificate holders of the above products for updates and details of the situation. Only 2 products are marketed in Hong Kong and they are registered by Fresenius Kabi Hong Kong Ltd: Voluven Infusion 6% (HK-50474) and Volulyte 6% Solution for Infusion (HK-58087). In view of the findings by EMA, a letter to inform healthcare professionals will be issued and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The Drug Office of Department of Health will remain vigilant on new safety information related to infusion solutions containing hydroxyethyl starch issued by other regulatory authorities.
Ends/ Saturday, June 15, 2013
Issued at HKT 12:00
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