May 23 2022

Classification of the active ingredient frovatriptan

Risk level in pregnancy: This medicine is classified as Category C.

The administration to pregnant rats during organogenesis period of 100, 500, and 1000 mg/kg/day of frovatriptan showed a dose-dependent relationship with the total number of fetuses with dilated ureters, pelvic cavitation, hydronephrosis and hydroureter. Failed to establish a dose-effect free of malformations. It was also detected a delay in maturation, with a delay in ossification in sternum, skull and nasal bones in all treated groups. The weight was slightly lower in treated animals, and there was an increased incidence of embryonic death.

Frovatriptan revealed clastogenic in cultured human lymphocytes in the absence of metabolic activation.

The manufacturer, in turn, states that there are no controlled studies on the influence of frovatriptan in humans, so that the safety of using this medication have not been established. Animal studies have demotrado reproductive toxicity.

The potential risk of using frovatriptan in pregnant women is unknown, so it should not be used during pregnancy unless clearly necessary.

Update 31.07.2009

Meaning of category C

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.