Pregnancy There are no studies in pregnant women, and case reports have been inadequate to inform of drug-associated risk Unknown if risk of major birth defects and miscarriage in patients with amyotrophic lateral sclerosis Animal data In studies in which riluzole was orally administered to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses Based on these results, advise women of possible risks to fetus associated with use of riluzole during pregnancy In rats, oral administration of riluzole resulted in decreased fertility indices and increases in embryo lethality Lactation Unknown if distributed...
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