Allergen Extracts Have High Safety Standards

Non standardized allergen extracts were safe to use

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) You may think of extracts as cooking ingredients but many extracts are used for medical purposes. A new study shows that many non-standardized allergen extracts are safe for diagnosis and treatment.

Many plant and animal extracts are developed to help diagnose and treat diseases. While some extracts are not standardized, the Food and Drug Administration (FDA) does review the extracts for effectiveness and safety.

If the extracts were unsafe that could lead to allergic reactions or anaphylactic shock.

"Ask your doctor about allergy testing and allergy extract use. "

The study was led by Jay E. Slater, M.D., Center for Biologics Evaluation and Research at the FDA. Researchers examined data and FDA recommendations of non-standardized allergen extracts since 1972 to test for safety and effectiveness.

The FDA has a list of 1,269 non-standardized extracts that range from plants to animals. The list includes extracts of cattle dander, rat hair, tree pollens, weed pollens, grass pollens, flower pollen, grain pollen, eggs, fish and shellfish, vegetables and fruits.

The extracts could be used to diagnose allergies or used in some form of treatment, such as immunotherapy.

Researchers determined safety and effectiveness by setting up certain thresholds as stands to measure against. Allergen extract use was responsible for 178 adverse reactions included anaphylaxis, bronchial spasms and angioedema, which is similar to hives.

Allergen extract use was responsible for 13 deaths since 1972.

The researchers concluded that as long as guidelines were followed, allergen extracts were safe to use. While the allergen extracts met safety standards set by the FDA, the effectiveness of the extracts left something to be desired.

Out of all the allergen extracts tested, only 54 percent met the thresholds for effectiveness. Considering that the extracts do not have standardized formulas, they are not measured against a standard for potency. Standardized allergen extracts include common irritants such as mites, cat hair, common grass pollens, ragweed and bee venom.

The level of effectiveness was due to most of the extracts, 565 in total, having little to no literature on how to use the extracts for diagnostic or treatment purposes. These extracts include camel hair, bay leaves and tree extracts such as willows and walnut.

Using the allergen extracts were safe so patients should be at ease for any testing or diagnostic purposes. Doctors need to consider the effectiveness of  these allergen extracts before any use.

The study was funded by the FDA.

The study was published in the April edition of the Journal of Allergy and Clinical Immunology.

Reviewed by: 
Review Date: 
April 12, 2012
Last Updated:
April 14, 2012