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The FDA states that “adequate and well-controlled studies with Otezla (apremilast)” have not yet been conducted in pregnant women.

The FDA concludes, however, that all pregnancies, specifically in mice and cynomolgus (crab-eating macaque) monkeys, which were studied, have a “background rate” of 2% to 4% for major malfunctions and 15% to 20% for pregnancy loss, regardless of the amount of drug exposure. For this reason, the FDA states that Otezla should only be used in pregnant women if the potential benefit outweighs the potential risk.

Otezla, Labor and Delivery

The effects of Otezla on labor and delivery in pregnant women are unknown.

Otezla and Lactation

It is unknown whether or not Otezla is present in human breast milk. In mice breast milk, however, Otezla was detected. Again, for this reason, it is critical to be cautious about the potential risks of taking Otezla while breastfeeding.

Otezla and Fertility

The effects of Otezla on human fertility are unknown. In male mice, however, the FDA reports no effects on fertility in doses up to 50mg/kg/day. In female mice, where oral doses of 10, 20, 40, or 80mg/kg/day were distributed, estrous (reproductive) cycles were prolonged. Further, mice that became pregnant while taking a 20mg/kg/day dose and greater had an increased chance of early postimplantation loss, according to the FDA.

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