Overview

Succinylated gelatin (modified fluid gelatin) is a synthetic colloid used for volume replacement. It is iso-oncotic in relation to plasma and has a half-life of four (4) hours¹.

Background of Safety Issue

In December 2016, the French regulatory agency, Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) approved a Direct Healthcare Professional Communication (DHPC) to inform health professionals regarding cross-reactions involving succinylated gelatin (modified fluid gelatin) products and galactose-alpha-1,3-galactose (alpha-gal).

Studies found that most patients with red meat allergies were sensitised to gelatin, and some of them were clinically allergic to both. Detection of alpha-gal in gelatin and correlation between the results of the alpha-gal and gelatin tests suggest the possibility that alpha-gal is one of the targets of reactivity to gelatin. The risk of anaphylactic reactions for succinylated gelatin (modified fluid gelatin) could be greatly increased in patients with a history of allergy to red meat or showing positive results in the anti-alpha-gal IgE test².

Adverse Drug Reaction Reports

NPRA has received 251 ADR reports with 326 adverse effects associated with the use of products containing succinylated gelatin (modified fluid gelatin). Of these, there are 27 reports of anaphylactic reactions/ anaphylaxis/ anaphylactic shock. However, it was not stated in these reports whether the patients had allergy to red meat/offal or positive anti-alpha-gal lgE test results³.

Advice for Healthcare Professionals

• The risk of sensitisation and consequent anaphylactic reaction to gelatin-containing solutions could be highly increased in patients with history of allergy to red meat (mammal meat) and offal, and/or those who tested positive for anti-alpha-gal IgE antibodies.
• In these patients, succinylated gelatin (modified fluid gelatin) should be administered only after a careful assessment of benefit/risk, including alternative treatments, and only under close supervision of well-trained personnel with resuscitation equipment ready.
• Please report any adverse drug reactions suspected to be associated with the use of succinylated gelatin (modified fluid gelatin) to NPRA.

A directive [Ruj. Kami: (28) dlm. BPFK/PPP/07/25 Jld. 2] has been issued by NPRA for updates to the local product packaging insert related to this safety issue. Please refer to the directive for more information.

References:

1. Soares, RR et al. (2009). Intraoperative volume replacement: crystalloids versus colloids in surgical myocardial revascularization without cardiopulmonary bypass. Rev. Bras. Anestesiol. 59(4): 439-451.
2. Agence Nationale de Sécurité du Médicament et des Produits de Santé (2016). DHPC – Gelofusine, Gelaspan and Plasmion (modified gelatin alone or in combination): risk of cross-reaction in case of allergy to red meat and offal.
3. The Malaysian Adverse Drug Reaction database, NPRA [Accessed: 24 May 2018]

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.