The US Food and Drug Administration (FDA) announces that it is requiring safety labeling changes to the prescribing information for the class of hydroxyethyl starch products to amend the Boxed Warning to warn about the risk of mortality, kidney injury, and excess bleeding. FDA is also requiring related changes to the Indications and Usage, Contraindications, Warnings and Precautions, and Adverse Reactions sections.
Hydroxyethyl starch (HES) products are approved for the treatment of hypovolemia (low blood volume). Recent data have associated administration of these products with certain serious risks. FDA has completed a review of data and information on the safety of HES products, including data from randomized clinical trials, meta-analyses, and observational studies. These data and information reflect the following serious risks associated with use of HES products:
- mortality, acute kidney injury (AKI) (including need for renal replacement therapy (RRT), and excess bleeding in surgical patients who are treated with HES products; and
- mortality and AKI in blunt trauma patients who are treated with HES products.
FDA has concluded that changes to the Boxed Warning are warranted to highlight the risk of mortality, kidney injury, and excess bleeding, as well as to include a statement that HES products should not be used unless adequate alternative treatment is unavailable. In addition, FDA has determined that changes should be made to other sections of the prescribing information for HES products, including the Indications and Usage, Contraindications, Warnings and Precautions, and Adverse Reactions sections.
Recommendation for Patients:
Patients should be aware of the risks associated with the use of HES products and discuss these risks with their healthcare provider.
- Be aware that death, kidney injury, and excess bleeding have been associated with the use of HES products.
- Be sure to follow up with your healthcare provider as requested and follow all instructions. Report any unusual symptoms immediately.
- Symptoms of kidney injury can include: change in the frequency, amount, or color of urine, blood in the urine, difficulty urinating, swelling of the legs, ankles, feet, face, or hands, unusual weakness or fatigue, nausea and vomiting, shortness of breath.
Information for Health Professionals:
Do not use HES products unless adequate alternative treatment is unavailable.
Please refer to the following website in FDA for details:
http://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/labeling-changes-mortality-kidney-injury-and-excess-bleeding-hydroxyethyl-starch-products
In Hong Kong, there are 4 registered pharmaceutical products containing hydroxyethyl starch, namely Voluven Infusion 6% (HK-50474) and Volulyte 6% Solution for Infusion (HK-58087) which are registered by Fresenius Kabi Hong Kong Limited; and Tetraspan 6% Solution for Infusion (HK-56978) and Tetraspan 10% Solution for Infusion (HK-56979) which are registered by B. Braun Medical (HK) Ltd. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to hydroxyethyl starch.
Related news on the increased risks of mortality, kidney injury and excess bleeding associated with the use of hydroxyethyl starch was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 15 Jun 2013, with the last update posted on 30 Jun 2018. Letters to inform local healthcare professionals were issued by the DH on 17 Jun 2013 and 15 Jan 2018.
In Dec 2013, the Registration Committee of the Pharmacy and Poisons Board decided that products containing hydroxyethyl starch should contain the relevant safety information (hydroxyethyl starch is contraindicated in sepsis, burns, renal impairment or renal replacement therapy, critically ill patients, etc., and in patients undergoing open heart surgery in association with cardiopulmonary bypass the use of hydroxyethyl starch is not recommended due to the risk of excess bleeding).
The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Jul 8, 2021
Issued at HKT 17:00
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