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Infliximab Pregnancy and Breastfeeding Warnings

Infliximab is also known as: Remicade

Infliximab Pregnancy Warnings

As of May 2000, the manufacturer (Centocor) has reported data on 27 women who were exposed to infliximab during the first trimester of pregnancy or immediately prior. There were three reports of miscarriages. One woman underwent an elective abortion (for personal reasons). One mother delivered a child with tetralogy of Fallot after a first trimester exposure to infliximab. One baby was born at week 37 and five babies were born at full term. A case has also been reported of a 26-year-old with a six-year history of colonic Crohn's disease who became pregnant while receiving infliximab infusions. She delivered her baby prematurely at week 24 of conception with a birth weight of 681 grams. The neonate had intracerebral and intrapulmonary bleeding, was disconnected from life support on day 3, and died shortly thereafter.

Infliximab has been assigned to pregnancy category B by the FDA. Animal reproduction studies have not been conducted with infliximab. There are no controlled data in human pregnancy. Infliximab is only recommended for use during pregnancy when benefit outweighs risk.

Infliximab Breastfeeding Warnings

There are no data on the excretion of infliximab into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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