Its Center for Veterinary Medicine announced Tuesday that producers using altrenogest products, which are delivered as a feed additive for gilts, need to be careful with how the products are handled.
Altrenogest products are a type of progestins and are used to delay estrus in horses and to synchronize estrus in gilts, the FDA said.
In swine, name brand products include Matrix, Chronomate and Swinemate, and the products can be purchased over-the-counter for use in feed, the agency said. In horses, the additive can be given orally or added to feed and brand name products include Regumate, Ovamed and Altren.
The FDA has received 130 reports of unintended human exposure – several of which were for the swine additive Matrix, which was approved in 2003, the agency said. There have been no reported incidents with generic versions of the products, but they were included in the safety communication as they work in the same manner.
“We issued the communication to remind people to clean up and decontaminate these areas so that others aren’t inadvertently exposed,” an agency spokesperson told FeedNavigator. “These products should be handled with care, and people administering them need to stay aware of the potential for adverse effects.”
In the last several years, there have been reported incidents where individuals came in contact with the medicated additive, she said. “We are particularly concerned about the reports affecting teenage girls,” she added.
“Most of these individuals were not directly handling the product, but were exposed when they touched equipment or surfaces that had product residue on them,” the spokesperson said.
Safety notice details
Among the reports of unintended exposure to the products some have involved exposure for multiple people, said the FDA.
“Adverse effects were reported in 137 people, including 115 women and 22 men,” the agency said. “Eighteen of the women affected were teenage girls – some reports have described adverse effects in girls as young as 14 years of age.”
Unintended contact and adverse events also may be under-reported, the FDA said. “Reproductive adverse effects reported in women and girls include abnormal or absent menstrual cycles, and in men include decreased libido. Other adverse effects reported after exposure include: headaches, fever, abdominal pain, nausea, diarrhea, vomiting and rashes.”
“Most people became exposed when the drug contacted their skin,” the agency said. “Some of these exposures have occurred when people, who did not administer the drug, touched product residue on barn surfaces, equipment, or treated animals.”
It is important for swine producers to take precautions to prevent exposure to the medicated additive, the agency said. Labeling calls for the use of “impermeable, non-porous protective gloves" and disposable latex gloves may not be adequate.
Any equipment used with the products and any spilled material needs to be cleaned and decontaminated to reduce the chance of unintended exposure, the agency said.
The agency is currently working with Merck, the company that sponsors both Regumate and Matrix, to establish potential processes to reduce the chance of accidental exposure, the spokesperson said.
“Any label changes would then automatically apply to the generic products,” she added.