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Dimethyl fumarate Pregnancy and Breastfeeding Warnings

Dimethyl fumarate is also known as: Tecfidera

Dimethyl fumarate Pregnancy Warnings

Animal studies have revealed evidence of embryofetotoxicity. There are no controlled data in human pregnancy. Dimethyl fumarate is only recommended for use during pregnancy when there are no alternatives and benefits outweigh risks. There is a pregnancy registry for dimethyl fumarate. Encourage pregnant patients to enroll at 1-800-456-2255. 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.

Dimethyl fumarate Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown The effects in the nursing infant are unknown.

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