Adverse Events

We are committed to safe, quality products and when things don’t go as planned (because sometimes they don’t) it is our policy to review, retest, and notify other customers when products do not meet high quality standards.If you experience an adverse event while using our products, we urge you to notify our office immediately.  Please call customer service at (515) 769-2340.

Important notice regarding the use of oral commercial milk replacer in foals receiving intravenous equine plasma:

For years plasma products have proven to be safe and are highly valued by leading veterinary clinics throughout the world. In an effort to make plasma products even safer, we have been pursuing underlying causes behind each adverse event. In pursuit thereof, there has been a significantly high correlation of foals receiving commercial milk replacer products prior to plasma administration and increased susceptibility to an adverse event. Our company has examined this trend since the 2005 foaling season and has examined the possibilities behind such adverse events both in vitro and in vivo.

Please use caution when administering plasma products post-administration to commercial milk replacer products.

We hypothesize that ingredients of bovine origin in milk replacer products may cross-react with equine antibodies later introduced to the foal through a plasma transfusion. This could occur as bovine proteins are introduced through the milk replacer and taken up systemically through the open gut. An adverse event may occur during equine plasma administration due to the possibility of anti-bovine antibody found in some equine blood products. These anti-bovine antibodies may exist in a donor’s plasma due to bovine-origin ingredients used in equine vaccine production. Another possibility for adverse events could be due to nonspecific equine antibody cross-reactivity with bovine protein. The slow and gradual introduction of bovine protein to the foal’s system can be immunologically tolerable. However, a sudden increase of nonspecific, cross-reactive antibody through a plasma transfusion could cause an immunological shock to the at-risk foal’s body. Either of these possibilities may cause a type II (cytotoxic) or type III (complement immune complex) hypersensitivity reaction.

As this is merely a postulate of the mechanism behind the adverse event, several observations support this correlation. While statistical data has been difficult to generate, we have followed this trend and found a strong correlation that leads us to notify the industry. We have been unable to reproduce this adverse event in vivo, however, we have been able to demonstrate light cross-reactivity between plasma and milk replacer or bovine serum in a series of agar gel immunodiffusion tests.

Further, one farm administered two liters of plasma each to 230 foals, of which only three foals received milk replacer prior to plasma administration; all three foals experienced an adverse event. One of the three foals did not begin milk replacement until it was 4 days old, suggesting that a risk may still be present even after gut closure. The three foals recovered fully following treatment.

Please note these observations are only correlations and lack conclusive scientific data proving plasma-transfused foals are more susceptible to adverse events with previous exposure to milk replacer. Due to the nature of biologics, not all foals that receive milk replacer and plasma will have an adverse event. This is an area of continued research for our company.

While we understand the need for plasma in conjunction with commercial milk replacer may still arise, we encourage veterinarians to administer plasma prior to the use of milk replacer. This could slow the rate at which antibody cross-reacts with bovine protein as the proteins will be taken up into the blood stream gradually, reducing the extent of immunological shock to the body. This is NOT an attempt to discredit or endorse any brand of commercial milk replacer, as it is a necessary product. This is a matter of product compatibility and not product quality.

We encourage customers to report every adverse event experienced, whether the event involves commercial milk replacer or not. Informing our company regarding an adverse event allows us to continue to maintain high plasma quality and identify risk factor trends. Please do not hesitate to contact Sarah Meyer at 515-769-2340 or by email at sarah at mgbiologics.com.