Nitisinone Pregnancy and Breastfeeding Warnings
Nitisinone is also known as: Orfadin
Nitisinone Pregnancy Warnings
Animal studies have shown incomplete skeletal ossification of fetal bones (at 0.4 to 20 times the recommended human dose), increased gestational length (at 4 to 20 times the recommended human dose), and decreased offspring survival (at 0.4 times the recommended human dose). In addition, reduced litter size, decreased birth weight, and decreased survival after birth was observed in animals receiving 12 times the recommended clinical dose based on relative body surface area. There are no controlled data in human pregnancy. FDA pregnancy 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.
FDA pregnancy category: C Potential benefit should outweigh the potential risk.
Nitisinone Breastfeeding Warnings
Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.
Animals exposed to nitisinone in breast milk showed signs of ocular toxicity and decreased body weight.
- nitisinone Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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