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FDA Alerts Veterinarians of Possible Risks of Using Altrenogest Products
USAgNet - 07/09/2018

The U.S. Food and Drug Administration is alerting veterinary medical professionals, as well as those who work with horses and pigs, that a synthetic progesterone product commonly used in these animals may cause reproductive system disorders and other adverse effects in people who become exposed to the drug. The FDA is providing this alert because of the nature of the adverse events, some of which have occurred in teenage girls.

Altrenogest belongs to the class of drugs called progestins and is used to suppress estrus (commonly called "heat" or "season") in mares (female horses), and to synchronize estrus in gilts (young female pigs).

It is marketed under several brand names, including the equine products Regumate, Ovamed and Altren; and the swine products Matrix, Chronomate and Swinemate. The equine products are available via a veterinarian's prescription and can be administered directly on the base of the mare's tongue or on the mare's feed. The swine products are available over-the-counter and are administered on a portion of the gilt's feed. These liquid products may be administered to the animals on a daily basis for prolonged periods of time.

The agency has received 130 reports of accidental human exposure to altrenogest products between October 6, 1987 and May 30, 2018; 121 of those were for Regumate, approved in 1983, and nine reports were for Matrix, approved in 2003.

Although the FDA has not received any reports for the other (generic) products, the agency's alert includes these products because they are used in the same manner as Regumate and Matrix and on the same animal populations, and therefore have the same risk for adverse events.

Some reports described exposures in more than one person. Adverse effects were reported in 137 people, including 115 women and 22 men. Eighteen of the women affected were teenage girls. Some reports have described adverse effects in girls as young as 14 years of age.

Most people became exposed when the drug contacted their skin. Some of these exposures have occurred when people, who did not administer the drug, touched product residue on barn surfaces, equipment, or treated animals.

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