The U.S. Food and Drug Administration reported today that it has approved the first drug to prevent fescue toxicosis, a disease that can cause reproductive problems in horses.
Equidone Gel (domperidone), which is marketed and distributed by Dechra Veterinary Products of Overland Park, Kan., is a dopamine antagonist that works at the cellular level to block the agonistic action of toxins produced by an endophytic fungus living on fescue grass.
The product is administered orally by syringe once a day. The gel comes in disposable 25 cc syringes that can be used for multiple doses. The strength is 110 mg domperidone per cc of gel.
The FDA has approved Equidone Gel (domperidone), a dopamine antagonist that works at the cellular level to block the agonistic action of toxins produced by an endophytic fungus living on fescue grass.
In a letter to veterinarians, the FDA said, “Equidone Gel is the only FDA-approved animal drug that contains domperidone as the active ingredient. Now that Equidone Gel is approved and available for veterinary use in the United States, domperidone should not be imported from other countries or compounded from bulk…You may have specific patients that require domperidone in strengths or forms that are not offered by Equidone Gel. In these limited cases, domperidone can only be legally compounded by using FDA-approved Equidone Gel as the starting material.”
The safety and effectiveness of Equidone Gel was evaluated in both laboratory and field studies. The most common side effects reported were premature lactation and failure of passive transfer.
Fescue makes up more than 35 million acres of pastureland in the United States, according to the FDA. The endophytic fungus, called Neotyphodium coenophialum, lives on the grass and produces toxins that interfere with the hormones involved in pregnancy and milk production.
Mares grazing on tall fescue pastures infected with the toxin can suffer from increased length of pregnancies; difficulty giving birth; mare and foal deaths; weak, stillborn or immature foals; agalactia; retained placentas; premature separation of the placenta at birth and increased placental weights and thickness, according to the FDA.