FDA Approves Drug That Reduces Gas Emissions From Animal, or Its Waste

Officials with the FDA have announced today the approval of lubabegron type A medicated article (Experior, Elanco), the first animal drug that when fed to beef cattle under specific conditions, results in less ammonia gas released as a byproduct of their waste.

Experior partially reduced ammonia gas emissions from manure from an individual animal or a pen of animals in semi-controlled conditions in enclosed housing, according to multiple studies of the drug that included 4,000 cattle. However, the studies did not measure ammonia gas emissions on a herd or farm scale. The results of the study showed a low incidence of health issues overall, and no difference between control animals and those receiving Experior.

In a simultaneous yet separate review, the Veterinary Drugs Directorate (VDD) of Health Canada has also reviewed Experior. This underscores the continued collaboration between the FDA’s Center for Veterinary Medicine and VDD, aimed at facilitating access to veterinary drugs across both countries, according to a briefing document from the FDA published online today.

Ammonia gas emissions can come from many sources, including the manure of beef cattle. Ammonia gas emissions are a concern because they have been implicated in atmospheric haze and noxious odors. High concentrations of ammonia can cause irritation of the eyes, nose and throat in both humans and animals. Additionally, ammonia gases can contribute to a process called eutrophication, in which bodies of water become enriched with excess nutrients, especially nitrogen and phosphorous. This nutrient enrichment in the water causes algae blooms, which block sunlight to aquatic plants, and eventually results in the death of aquatic animals due to a lack of oxygen in the water.

Reference

FDA In Brief: FDA approves first animal drug that reduces gas emissions from an animal or its waste [FDA brief]. Gaithersburg, MD; FDA website: November 6, 2018. https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm625209.htm