Hydroxyethyl Starch Solutions: FDA Safety Communication – Boxed Warning on Increased Mortality and Severe Renal Injury and Risk of Bleeding

June 26, 2013

June 26, 2013 – The American Food and Drug Administration (FDA) has just released (June 06 2013) the following important information concerning patients who receive hydroxyethyl Starch (HES) solutions in the course of their treatment.

ISSUE: FDA has analyzed recent data that indicate an increased risk of (i) mortality and renal injury requiring renal replacement therapy in critically ill adult patients, including patients with sepsis and those admitted to the ICU; and (ii) excess bleeding particularly in patients undergoing open heart surgery in association with cardiopulmonary bypass. Refer to the FDA Safety Communication for more details about the data analysis.

FDA has concluded that HES solutions should not be used in critically ill adult patients, including patients with sepsis and those admitted to the ICU, and a Boxed Warning to include the risk of mortality and severe renal injury is warranted. In addition, FDA has reviewed a meta-analysis of studies conducted in patients undergoing open heart surgery in association with cardiopulmonary bypass and has determined that an additional warning about excessive bleeding is needed in the Warnings and Precautions Section of the package insert.

BACKGROUND: Hydroxyethyl starch (HES) solutions are used for the treatment of hypovolemia (low blood volume) when plasma volume expansion is desired. Recent data have associated the use of these products with an increased risk of severe adverse events when used in certain patient populations.

RECOMMENDATION: Patients should be aware of the risks associated with the use of HES solutions and discuss these risks with their healthcare provider (refer to the FDA Safety Communication for detailed recommendations for patients).

Recommendations for Health Professionals include the following:

– Do not use HES solutions in critically ill adult patients including those with sepsis, and those admitted to the ICU.
– Avoid use in patients with pre-existing renal dysfunction.
– Discontinue use of HES at the first sign of renal injury.
– Need for renal replacement therapy has been reported up to 90 days after HES administration. Continue to monitor renal function for at least 90 days in all patients.
– Avoid use in patients undergoing open heart surgery in association with cardiopulmonary bypass due to excess bleeding.
– Discontinue use of HES at the first sign of coagulopathy.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[06/24/2013 – FDA Safety Communication – FDA]


Risk of serious fungal infections with Golimumab [Simponi]

May 31, 2009

May 31, 2009 – In a safety information to rheumatological healthcare professionals, posted May 27, 2009, FDA and Centocor Ortho Biotech remind healthcare professionals of the risk of srious fungal infections associated with Tumor Necrosis Factor – alpha (TNF-α) inhibitors, including Golimumab [Simponi].

2009 05 29 Golimumab [Simponi] Illustration enIn earlier communications, FDA has reported that histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking other TNF-α inhbitors such as Certolizumab [Cimzia], Etanercept [Enbrel], Adalimumab [Humira], and Infliximab [Remicade]. This has resulted in delays in the approriate antifungal treatment of affected patients, sometimes even resulting in death. It is important that all adverse events potentially associated with Golimumab [Simponi] be reported by patients and healthcare professionals alike so that the adverse event profile reported in the prescribing information can be updated appropriately as post-approval experience is gathered.

Read the May 2009 Dear Healthcare Professional Letter sent out by Centocor here. The Prescribing Information and Medication Guide for Golimumab [Simponi] is available here. Please report any adverse event with Golimumab [Simponi] to the FDA MedWatch Program.

It should be noted here that all TNF-α inhibiting drugs mentioned herein, inclusive Golimumab [Simponi] carry in their prescribing information “Boxed Warnings” which alert to the serious riks for infections and sometimes other serious conditions (follow the links above for further details).


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