Safety Trials

GASTROGARD was well tolerated in controlled efficacy and safety studies.

In the previously described dose-confirmation and field trials, no adverse effects attributable to omeprazole treatment were noted.⁶

Additional safety studies were conducted in which clinical chemistry, hematology, and physical examinations were performed, and tissues and organs were examined at necropsy for gross lesions. Tissue samples were also taken for histopathologic examination.⁶

In the first of these trials, a sham dose-controlled safety study, 18 Thoroughbred horses (9 geldings and 9 females) ranging in age from 4 to 20 years received 20 mg/kg/day omeprazole (5x the recommended dose) or sham dosing for 91 days.6 In a second, placebo-controlled tolerance study, six adult Thoroughbred horses (3 gelded males and 3 females) were treated with GASTROGARD at a dosage of 40 mg/kg/day (10x the recommended dose) or sham dosed for 3 weeks, then necropsied. In addition to twice-daily observations, physical examinations were conducted on days -1, 2, 9, and 21. In both studies, no treatment-related adverse effects on the animals' health were observed.⁶

A placebo-controlled study in foals evaluated the safety of GASTROGARD at doses of 4, 12, or 20 mg/kg (1x, 3x, or 5x the recommended dose) once daily for 13 weeks. Twenty-four Tennessee Walking Horse foals (12 female and 12 male) ranging in age from 66 to 110 days at study initiation were randomly assigned to treatment groups. Each foal was observed at least twice daily, and physical examinations were conducted at weeks 1, 2, 4, 8, and 13. Overall, GASTROGARD given orally tyoung horses at 1x, 3x, or 5x the recommended daily dose had no adverse effects on animal health.⁶

Reproductive Safety

In a male reproductive safety study, 15 Thoroughbred and 5 Standardbred stallions between 3 and 12 years of age were randomly assigned to receive GASTROGARD at 12 mg/kg/day (3x the recommended dose) or sham dosing for 71 days. Semen quality, reproductive behavior, and genitalia were examined to assess breeding soundness. No treatment-related adverse effects on semen quality, testicular volume, or reproductive behavior were observed.^6> A safety study in breeding mares has not been conducted.

Safe for Concomitant Use

In the clinical trials, GASTROGARD was used concomitantly with other therapies, which included anthelmintics, antibiotics, nonsteroidal and steroidal anti-inflammatory agents, diuretics, tranquilizers,and vaccines. No interactions were observed.