According to a news report on cbsnews.com, the United States Food and Drug Administration is warning of defective negative food allergy test kits that are causing Anaphylaxis, injuries, and potential fatalities. Allergy skin tests are used to check children and adults for food allergies. If the food allergy test kits provide false negative results, adults and children could suffer potentially life-threatening allergic reactions because they are mistakenly told they do not have certain allergy risks. The FDA will now require skin tests to include a warning asking doctors to consider double-checking the skin test results with more accurate methods.
Back in December, the U.S. FDA reported it had received “increased” incident reports of false negatives from certain kits manufactured by ALK-Abello. Those affected kits are used to diagnose peanut allergies. Peanut allergies are often considered one of the most deadly food allergies because they can cause a severe and potentially life-threatening allergic reaction called Anaphylaxis. Anaphylaxis is a severe allergic reaction that can affect the entire body, leading to a sudden drop in blood pressure and difficulty breathing. If left untreated, Anaphylaxis can be fatal.
Peanuts are a common ingredient in many foods, and it can be difficult to avoid them completely. Even trace amounts of peanuts or peanut residue can trigger an allergic reaction in some people. In addition, peanuts are often processed in the same facilities or on the same equipment as other foods, which can lead to cross-contamination and accidental exposure.
For people with peanut allergies, it is important to avoid all foods that contain peanuts or peanut products and to carry emergency medications such as epinephrine to treat Anaphylaxis in case of accidental exposure. It’s also important to be aware of the signs and symptoms of Anaphylaxis and to seek emergency medical attention if symptoms occur.
The FDA also reported that these false negative results had not been an isolated issue. Moreover, some of the liquid extracts that are used to test for non-food allergic reactions are standardized to meet specific potency benchmarks. However, the FDA stated that the extracts used for testing food allergies, such as peanuts, do not have specific potency benchmarks to meet.
ALK-Abello and Greer Laboratories, the makers of the most popular food allergy skin test kits, did not provide any comments concerning the FDA’s new labeling requirement.
The peanut skin test kits that were part of the FDA’s initial recall had about 90 cases of false negative results. Of those, there were 17 reports of serious injury.
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